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1.  Effect of Intrathecal Baclofen Concentration on Spasticity Control: Case Series 
Background/Objective:
Intrathecal baclofen (ITB) has been shown to be an effective treatment for severe spasticity of spinal or cerebral origin. Although most patients respond well to an ITB trial, there are often difficulties in achieving and/or maintaining such effectiveness with ITB pump treatment. There are few published guidelines for dosing efficacy and no studies looking at the effect of concentration of ITB on spasticity management.
Methods:
Case series of 3 adults with severe spasticity treated with ITB pump: a 44-year-old man with C7 tetraplegia using a 40-mL Medtronic SynchroMed II pump with 500-μg/mL concentration; a 35-year-old woman with traumatic brain injury with right spastic hemiplegia using a 18-mL Medtronic SynchroMed EL pump with 2,000-μg/mL concentration; and a 43-year-old woman with spastic diplegic cerebral palsy using a 40-mL Medtronic SynchroMed II pump with 2,000-μg/mL concentration.
Results:
After reducing ITB concentrations in the pump, either as part of a standard protocol for dye study to assess the integrity of pump and catheter system or secondary to plateau in therapeutic efficacy, patients experienced temporary, significant reduction in spasticity based on range of motion, Modified Ashworth scores, and verbal feedback.
Conclusions:
Decreasing the concentration of ITB seems to affect spasticity control. Further research in this area is needed for those patients with refractory spasticity to optimize efficacy of ITB therapy.
PMCID: PMC2582431  PMID: 18959357
Spasticity; Baclofen; Intrathecal; Tetraplegia; Hemiplegia; Cerebral palsy; Traumatic brain injury
2.  Lasting reduction of severe spasticity after ending chronic treatment with intrathecal baclofen. 
OBJECTIVE--To investigate whether the dose of intrathecal baclofen necessary for a sufficient reduction of muscle tone and spasms changes during treatment of severe spasticity. METHODS--A group of 27 patients received intrathecal baclofen for 61 (SD 18) months. RESULTS--Spasticity remained absent or strongly reduced after stopping the intrathecal baclofen infusion in seven patients. The dose of baclofen could be reduced to 40% of that dose which was originally necessary in 10 patients. The dose remained the same or increased slightly in 10 patients. Possible reasons for the continuing reduction of spasticity after terminating long term intrathecal baclofen infusion in some patients could be: lasting morphological changes in spinal cord neurons by second messenger controlled modulation of gene expression, a toxic effect of baclofen on spinal neurons, muscular atrophy, inflammation due to the catheter, or progression of multiple sclerosis. CONCLUSIONS--A higher initial daily dose of intrathecal baclofen might lead to a faster, lasting suppression of spasticity and the development of spastic symptoms might even be prevented by pre-emptive treatment with baclofen in patients with newly acquired lesions of the spinal cord.
PMCID: PMC1073798  PMID: 8708647
3.  Intrathecal baclofen: Its effect on symptoms and activities of daily living in severe spasticity due to spinal cord injuries: A pilot study 
Indian Journal of Orthopaedics  2009;43(1):46-49.
Background:
Spasticity is a major problem related to spinal cord injuries. Use of intrathecal baclofen with an implanted pump seems a very useful mode of therapy in patients in whom oral antispasmodic agents are either not effective or produce intolerable side-effects.
Materials and Methods:
Twenty-four patients with mean age 50 years (range 32-72 years) had intrathecal baclofen pump implanted for the severe spasticity of spinal origin. One patient died following implantation of pump due to natural causes and was not included in the study. The patients were followed up for mean 22 months (range, one to five years).
Results:
All 24 patients showed improvement in their spasm following the procedure. Improvement was noted in pain (12), sleep disturbance (20) and sphincter control (14). Patients had improvement in activities of daily living such as feeding ability (10), self care (10), indoor and outdoor mobility (19), and driving (4). One patient had catheter leakage immediately after the surgery and required change of catheter. The radio telemetry allows very good adjustment of the dose according the individual patients needs.
Conclusion:
Intrathecal baclofen pump improves the symptoms of spasm and also the quality of life. It helps the patient to live more independently. It is not an irreversible surgery for the patient and hence it is very useful in the changing the dynamics in this group of patients.
doi:10.4103/0019-5413.45323
PMCID: PMC2739492  PMID: 19753179
Activities of daily living; intrathecal baclofen; spasticity; spinal cord injury
4.  Effects of Intrathecal Baclofen on Perceived Sexual Functioning in Men With Spinal Cord Injury 
Background/Objective:
Reports in the literature suggest that administration of intrathecal baclofen to control spasticity may have deleterious effects on erectile function in men with spinal cord injury (SCI). A prospective study was conducted to document any changes in perceived sexual function after implant of a baclofen pump.
Methods:
Seven adult men with SCI (ASIA A or B) who received intrathecal baclofen through an implantable pump for treatment of severe spasticity were followed for an average of 670 days (22.4 months) after implant. Perceived sexual function was assessed using the Brief Sexual Function Inventory. Severity of spasticity and overall health-related quality of life were also assessed.
Results:
Participants reported improvements in spasticity severity and overall health-related quality of life. Two of 7 participants reported some negative changes in perceived sexual function after baclofen pump implant, noted in the areas of reduced sex drive and problems with erections (frequency, rigidity, difficulty in achieving). However, most participants reported minimal effects on sexual function, and 2 participants reported marked improvement in perceived sexual function from pre- to post-implant. Analysis of changes in perceived sexual function over time suggest that problems may be associated with an increase in baclofen dose and may be reversible with a reduction in dose.
Conclusions:
Intrathecal baclofen may impact perceived sexual function particularly at higher doses. However, the effects seem to be reversible with withdrawal or reduction of baclofen administration.
PMCID: PMC2435042  PMID: 18533419
Spinal cord injuries; Baclofen; Spasticity; Sildenafil citrate; Sexual function; Erectile dysfunction
5.  Intrathecal Baclofen Pump for Spasticity 
Executive Summary
Objective
To conduct an evidence-based analysis of the effectiveness and cost-effectiveness of intrathecal baclofen for spasticity.
The Technology
Spasticity is a motor disorder characterized by tight or stiff muscles that may interfere with voluntary muscle movements and is a problem for many patients with multiple sclerosis (MS), spinal cord injury (SCI), cerebral palsy (CP), and acquired brain injury (ABI).(1). Increased tone and spasm reduces mobility and independence, and interferes with activities of daily living, continence and sleep patterns. Spasticity may also be associated with significant pain or discomfort (e.g., due to poor fit in braces, footwear, or wheelchairs), skin breakdown, contractures, sleep disorders and difficulty in transfer.
Goals of treatment are to decrease spasticity in order to improve range of motion, facilitate movement, reduce energy expenditure and reduce risk of contractures. Existing treatments include physical therapy, oral medications, injections of phenol or botulinum toxin, or surgical intervention.
Baclofen is the oral drug most frequently prescribed for spasticity in cases of SCI and MS.(1) Baclofen is a muscle relaxant and antispasticity drug. In the brain, baclofen delivered orally has some supraspinal activity that may contribute to clinical side effects. The main adverse effects of oral baclofen include sedation, excessive weakness, dizziness, mental confusion, and somnolence.(2) The incidence of adverse effects is reported to range from 10% to 75%.(2) Ochs et al. estimated that approximately 25-30% of SCI and MS patients fail to respond to oral baclofen.(3;4)
Adverse effects appear to be dose-related and may be minimized by initiating treatment at a low dose and gradually titrating upwards.(2) Adverse effects usually appear at doses >60 mg/day.(2) The rate of treatment discontinuation due to intolerable adverse effects has generally been reported to range from 4% to 27%.(2)
When baclofen is administered orally, only a small portion of the original dose crosses the blood brain barrier and enters the central nervous system (CNS) fluid, which is the site of drug action. In order to bypass the oral route, baclofen may be administered intrathecally by infusion directly to the CNS.
Candidates for intrathecal baclofen infusion are patients with spasticity who have intractable spasticity uncontrolled by drug therapy, or who experience intolerable side effects from oral baclofen.
Advantages of intrathecal baclofen infusion are:
Direct drug administration to the cerebrospinal fluid (CSF)
The central side effects of oral baclofen, such as drowsiness or confusion, appear to be minimized with intrathecal administration.
The intrathecal delivery of baclofen concentrates the drug in the CSF at higher levels than those attainable via the oral route.
Intrathecal administration can use concentrations of baclofen of less than one hundredth of those used orally.(5)
Adjustable/programmable continuous infusion makes it possible to finely titrate patients’ doses and to vary the doses over the hours of the day. For example, the dose can be relatively low to give the patients the extensor tone needed for ambulation during the day and increased at night, thereby improving quality of sleep.
Reversible (in contrast to surgery).
A patient who is a candidate for intrathecal baclofen infusion must have no contraindications to the insertion of an intrathecal catheter (e.g., anticoagulant therapy, coagulopathy, local or systemic infection, anatomical abnormality of the spine).
Review Strategy
The Medical Advisory Secretariat reviewed the literature to assess the effectiveness, safety, and cost-effectiveness of intrathecal baclofen to treat patients who have intractable spasticity uncontrolled by drug therapy, or who experience intolerable side effects to oral baclofen.
The Medical Advisory Secretariat used its standard search strategy to retrieve international health technology assessments and English-language journal articles from selected databases.
Summary of Findings
Level 2 evidence supports the effectiveness of intrathecal baclofen infusion for the short-term reduction of severe spasticity in patients who are unresponsive or cannot tolerate oral baclofen
Level 3 evidence supports the effectiveness of intrathecal baclofen for the long-term reduction of severe spasticity in patients who are unresponsive or cannot tolerate oral baclofen
Level 4 qualitative evidence demonstrates functional improvement for patients who are unresponsive or cannot tolerate oral baclofen
Intrathecal baclofen is cost-effective with costs which may or may not be avoided in the Ontario health system
True functional use remains to be determined
PMCID: PMC3382401  PMID: 23074476
6.  Intrathecal baclofen therapy in severe head injury, first time in Nepal, a technique suitable for underdeveloped countries 
Asian Journal of Neurosurgery  2011;6(1):49-51.
Intrathecal baclofen (ITB) has been found to be helpful not only for spasticity but also for unconsciousness in a vegetative patient. This is the first case of ITB in Nepal, and here we discuss the effectiveness of ITB for spasticity in a patient in vegetative state. We also discuss about a simple technique for ITB used in Nepal where baclofen pump is not available. Here, we present a case of a 40-year-old male patient who had severe head injury with diffuse axonal injury treated conservatively. He went on to a vegetative state and subsequently developed severe spasticity of all the limbs. ITB was started under the guidance of one of the authors , Prof. Taira. Baclofen was injected to the spinal intrathecal space through a catheter which is used for spinal anesthesia. Spasticity improved significantly and his higher mental function also showed signs of improvement. He finally became fully conscious and well oriented. ITB is very useful in cases of severe spasticity and vegetative condition, a state of unconsciousness lasting longer than a few weeks. Even with a simple technique in the absence of baclofen pump, ITB can be used with its optimum effect.
doi:10.4103/1793-5482.85638
PMCID: PMC3205552  PMID: 22059105
Intrathecal baclofen; Nepal; spasticity; vegetative state
7.  Intrathecal baclofen withdrawal syndrome- a life-threatening complication of baclofen pump: A case report 
Background
Intrathecal baclofen pump has been used effectively with increasing frequency in patients with severe spasticity, particularly for those patients who are unresponsive to conservative pharmacotherapy or develop intolerable side effects at therapeutic doses of oral baclofen. Drowsiness, nausea, headache, muscle weakness, light-headedness and return of pretreatment spasticity can be caused by intrathecal pump delivering an incorrect dose of baclofen. Intrathecal baclofen withdrawal syndrome is a very rare, potentially life-threatening complication of baclofen pump caused by an abrupt cessation of intrathecal baclofen.
Case presentation
A 24-year-old man with a past medical history of cerebral palsy and spastic quadriparesis developed hyperthermia, disseminated intravascular coagulation, rhabdomyolysis, acute renal failure and multisystem organ failure leading to a full-blown intrathecal baclofen withdrawal syndrome. Intrathecal baclofen pump analysis revealed that it was stopped due to some programming error. He was treated effectively with supportive care, high-dose benzodiazepines and reinstitution of baclofen pump.
Conclusion
The episodes of intrathecal baclofen withdrawal syndrome are mostly caused by preventable human errors or pump malfunction. Educating patients and their caregivers about the syndrome, and regular check-up of baclofen pump may decrease the incidence of intrathecal baclofen withdrawal syndrome. Oral baclofen replacement may not be an effective method to treat or prevent intrathecal baclofen withdrawal syndrome. Management includes an early recognition of syndrome, proper intensive care management, high-dose benzodiazepines and prompt analysis of intrathecal pump with reinstitution of baclofen.
doi:10.1186/1472-6904-4-6
PMCID: PMC514562  PMID: 15301690
8.  Baclofen Pump Intervention for Spasticity Affecting Pulmonary Function 
Introduction:
Muscle spasticity may adversely affect pulmonary function after spinal cord injury (SCI). However, there is limited information regarding the treatment of spasticity as a determinant of pulmonary function. This study presents the case of a man with C4 tetraplegia who had severe spasticity and difficulty weaning from ventilatory support.
Methods:
Case presentation.
Results:
Severe spasticity likely contributed to respiratory compromise in this patient. Successful and rapid weaning from the ventilator occurred within 3 weeks of baclofen pump placement.
Conclusions:
Randomized clinical trials among SCI patients with significant spasticity are needed to determine whether intervention with a baclofen pump facilitates earlier ventilatory weaning.
PMCID: PMC1864906  PMID: 16396387
Spinal cord injuries; Spasticity; Ventilator weaning; Baclofen pump; Respiratory impairment; Tetraplegia
9.  Complications of Intrathecal Baclofen Pump: Prevention and Cure 
ISRN Neurology  2012;2012:575168.
Increasingly, spasticity is managed with surgically implanted Intrathecal Baclofen pumps. Intrathecal Baclofen pump revision surgery unrelated to programmable pump end-of-life is not uncommon, requiring special attention during pre-, intra-, and postoperative management. We aimed to identify and describe complications of Intrathecal Baclofen pump as well as to report avoidance and management of complications. Methods and Materials. Through 2002–2006, at the department of neurosurgery, Henry Ford and Oakwood Health Systems, Intrathecal Baclofen pumps were implanted in 44 patients: 24 children versus 20 adults; 30 “primary-implant-patients”; 14 “revision-only patients”. We evaluated reasons for revision surgeries and diagnostic workup requirements. Results. Eight primary-implant-patients required 14 revisions and 7 of revision-only patients needed 13 procedures. Seven patients with slowly increasing baclofen-resistant spasticity had either (i) unsuspected pump-catheter connector defects, (ii) an X-ray-documented pump-catheter connector defect, (iii) X-ray-demonstrated fractured catheter with intrathecal fragment. Implant infections occurred in 4 cases. Scintigraphy revealed occult CSF leakage N=1 and intrinsic pump failure N=1. Conclusion. Intrathecal Baclofen pumps, although very gratifying, have a high, technique-related complication incidence during implant life. Meticulous technique, high clinical suspicion, appropriate workup, and timely surgical management can reduce surgical complications of Intrathecal Baclofen pump implantation.
doi:10.5402/2012/575168
PMCID: PMC3323842  PMID: 22548189
10.  Intrathecal baclofen for long-term treatment of spasticity: a multi-centre study. 
Twenty eight patients with severe, intractable spasticity have been treated by chronic intrathecal administration of baclofen. An implantable programmable drug-administration-device (DAD) was used with a permanent intrathecal catheter. Infusion of 50 to 800 micrograms/day of baclofen completely abolished spasticity. Follow-up was up to two years. Therapeutic effect was documented by clinical assessment of tone, spasms and reflexes and by electrophysiological recordings of mono- and polysynaptic reflex activity. Complications and untoward side-effects of the procedure were few. This procedure is recommended for spasticity of spinal origin refractory to physiotherapy and oral medication. It is a preferable alternative to ablative surgical intervention.
PMCID: PMC1031830  PMID: 2487035
11.  Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity 
OBJECTIVES—To compare clinical effectiveness and health related quality of life in patients with severe spasticity who received intrathecal baclofen or a placebo.
METHODS—In a double blind, randomised, multicentre trial 22 patients were followed up during 13 weeks and subsequently included in a 52 week observational longitudinal study. Patients were those with chronic, disabling spasticity who did not respond to maximum doses of oral baclofen, dantrolene, and tizanidine. After implantation of a programmable pump patients were randomly assigned to placebo or baclofen infusion for 13 weeks. After 13 weeks all patients received baclofen. Clinical efficacy was assessed by the Ashworth scale, spasm score, and self reported pain, and health related quality of life by the sickness impact profile (SIP) and the Hopkins symptom checklist (HSCL).
RESULTS—At three months the scores of the placebo and baclofen group differed slightly for the spasm score (effect size=0.20) and substantially for the Ashworth scale (effect size=1.40) and pain score (effect size=0.94); health related quality of life showed no significant differences. Three months after implantation the baclofen group showed a significant, substantial improvement on the SIP "physical health", "mental health", "mobility", and "sleep and rest" subscales and on the HSCL mental health scale; patients receiving placebo showed no change. After one year of baclofen treatment significant (P<0.05) improvement was found on the SIP dimensions "mobility" and "body care and movement" with moderate effect sizes. Improvement on the SIP subscale "physical health" (P<0.05; effect size 0.86), the SIP overall score (without "ambulation"), and the "physical health" and overall scale of the HSCL was also significant, with effect sizes >0.80. Changes in health related behaviour were noted for "sleep and rest" and "recreation and pastimes" (P<0.01, P<0.05; effect size 0.95 and 0.63, respectively). Psychosocial behaviour showed no improvement.
CONCLUSIONS—Intrathecal baclofen delivered by an implanted, programmable pump resulted in improved self reported quality of life as assessed by the SIP, and HSCL physical health dimensions also suggest improvement.


PMCID: PMC2169658  PMID: 9285459
12.  How should an infected perinephric haematoma be drained in a tetraplegic patient with baclofen pump implanted in the abdominal wall? – A case report 
BMC Urology  2002;2:9.
Background
We present a case to illustrate controversies in percutaneous drainage of infected, perinephric haematoma in a tetraplegic patient, who had implantation of baclofen pump in anterior abdominal wall on the same side as perinephric haematoma.
Case presentation
A 56-year-old male with C-4 tetraplegia had undergone implantation of programmable pump in the anterior abdominal wall for intrathecal infusion of baclofen to control spasticity. He developed perinephric haematoma while he was taking warfarin as prophylactic for deep vein thrombosis. Perinephric haematoma became infected with a resistant strain of Pseudomonas aeruginosa, and required percutaneous drainage. Positioning this patient on his abdomen without anaesthesia, for insertion of a catheter from behind, was not a realistic option. Administration of general anaesthesia in this patient in the radiology department would have been hazardous.
Results and Conclusion
Percutaneous drainage was carried out by anterior approach under propofol sedation. The site of entry of percutaneous catheter was close to cephalic end of baclofen pump. By carrying out drainage from anterior approach, and by keeping this catheter for ten weeks, we took a risk of causing infection of the baclofen pump site, and baclofen pump with a resistant strain of Pseudomonas aeruginosa. The alternative method would have been to anaesthetise the patient and position him prone for percutaneous drainage of perinephric collection from behind. This would have ensured that the drainage track was far away from the baclofen pump with minimal risk of infection of baclofen pump, but at the cost of incurring respiratory complications in a tetraplegic subject.
doi:10.1186/1471-2490-2-9
PMCID: PMC128809  PMID: 12220481
13.  Management of severe spasticity with intrathecal baclofen delivered by a manually operated pump. 
Intrathecal baclofen abolishes spasticity in many patients with neurological diseases but there are few studies on its long-term effectiveness. Since 1986 a manually operated subcutaneous pump has been used to deliver baclofen intrathecally in 21 patients with a follow up of at least one year. Most patients had multiple sclerosis and all were wheelchair-bound. Sixteen patients had a complete and sustained benefit. In four other patients the treatment was effective in the short term but not in the long term. In the remaining patient the pump never worked. Complications included meningitis, pump failure, erosion through the skin, and baclofen overdose. Nevertheless, only three patients have asked to discontinue the treatment. We conclude that intrathecal baclofen, delivered by a manually operated implanted pump, is an effective treatment for severe spasticity in most patients.
PMCID: PMC1072919  PMID: 8201328
14.  Sexual Dysfunction Associated With Intrathecal Baclofen Use: A Report of Two Cases 
Background/Objective:
Intrathecal baclofen is considered standard treatment for severe spasticity of spinal cord and cerebral origin. Recognized side effects include fatigue and constipation. There are few reported findings of sexual dysfunction in men and none in women.
Methods:
Two case reports.
Results:
A male and a female patient with spasticity treated with intrathecal baclofen were recognized to have sexual dysfunction side effects from treatment. On reduction of the intrathecal baclofen dose, complete return to baseline sexual function was achieved for both subjects.
Conclusions:
Intrathecal baclofen can impair sexual function and ejaculation in some patients. Clinicians should be aware of this risk and ask about it during routine clinic follow-up for spasticity. Dosing adjustments need to be considered in these patients.
PMCID: PMC2435028  PMID: 18533420
Baclofen; Intrathecal; Spinal cord injuries; Cerebral palsy; Sexual dysfunction; Spasticity; Gamma-aminobutyric acid-B receptors
15.  Clinical and Neurophysiologic Assessment of Strength and Spasticity During Intrathecal Baclofen Titration in Incomplete Spinal Cord Injury: Single-Subject Design 
Background/Objective:
Spasticity after spinal cord injury (SCI) is commonly managed with oral and intrathecal baclofen (ITB), with less attention to the effects on voluntary motor control. Studies combining clinical and neurophysiologic assessments during dose optimization are rare. Study aims (a) systematically evaluate effects of varied doses of oral and ITB on clinical and neurophysiologic measures of strength and spasticity and (b) relate clinical and neurophysiologic findings.
Methods:
A 41-year-old man with an incomplete T11-ASIA D SCI was studied during ITB titration. Spasticity and strength in the lower extremities were assessed clinically and neurophysiologically at 5 different daily dosages of baclofen: (a) 80 mg oral, (b) 80 mg oral/50 μg ITB, (c) 80 mg oral/125 μg ITB, (d) 30 mg oral/125 μg ITB, and (e) 125 μg ITB only.
Results:
A dose-dependent change in the Ashworth score and lower limb motor score was observed during titration of oral and ITB. Whereas the Hoffman (H)-reflex was abolished after the introduction of ITB, the flexion withdrawal reflex approximated a dose-dependent pattern. Changes in the motor score and EMG during voluntary muscle activation were proportionally smaller than the corresponding changes in clinical and neurophysiologic measures of spasticity. Neurophysiologic assessment largely paralleled clinical findings.
Conclusions:
This single-subject study shows that the control of spasticity can be achieved without detrimental effects on strength in incomplete SCI and suggests the need for including strength testing in comprehensive clinical assessment of spasticity. The study shows convergent validity between clinical and neurophysiologic assessments during ITB dose titration. Adding neurophysiologic assessment to clinical assessment may provide objectivity and sensitivity and facilitate decision-making during ITB titration.
PMCID: PMC2678290  PMID: 19569466
Spinal cord injuries; Paraplegia; Spasticity; Hypertonia; Muscle strength; Baclofen; Intrathecal; Reflexes; Hoffman reflex
16.  Intrathecal Baclofen for Spasticity Management: A Comparative Analysis of Spasticity of Spinal vs Cortical Origin 
Background/Objective:
To examine the differences in intrathecal baclofen management of individuals with spasticity of cortical vs spinal etiologies.
Design:
Retrospective chart review of 57 individuals with the diagnoses of severe cortical and spinal spasticity requiring an intrathecal baclofen pump.
Methods:
Parameters evaluated included daily dosage of medication required, flex vs simple continuous delivery modes, dosing changes, need for other local spasticity treatment, and catheter complications.
Results:
There were no statistically significant differences between individuals with cortical spasticity and spinal spasticity when comparing daily dosage, number of contacts, and mode of delivery. At 6 months, there was a statistically significant difference in dosing between individuals with multiple sclerosis and those without. Within groups, there was a significant difference in average daily dosing over 3 years. A significant difference was found comparing the use of botulinum toxin type A for upper extremity spasticity within the cortical group. Nine individuals had catheter complications.
Conclusions:
Cortical and spinal spasticity appear to parallel each other with no significant differences in daily dosing, dosing changes, and mode of delivery of intrathecal baclofen. This did not hold true at all time points for the multiple sclerosis subgroup. The significant difference noted within groups for daily dosing over the first 3 years challenges the notion of stable dosing over time. Focal injections of Botox/phenol in the upper extremities are an important adjunct therapy for patients with cortical spasticity, even after the placement of an intrathecal baclofen pump. Our complication rate was slightly lower than that reported in the literature.
PMCID: PMC2853324  PMID: 20397440
Spinal cord injuries; Multiple sclerosis; Cerebral palsy; Stroke; Brain injury, traumatic; Baclofen, intrathecal; Botulinum toxin type A; Phenol; Spasticity, cortical, spinal; Intrathecal pump
17.  Intrathecal baclofen and the H-reflex. 
Baclofen was given intrathecally to six patients with severe lower limb spasticity due to traumatic spinal cord injury. The effects of the drug on spasticity and the ratio between the maximum amplitude of the H reflex and the M response from the soleus (Hmax/Mmax ratio) were assessed. In each patient, spasticity was reduced following intrathecal baclofen and in four patients there was a reduction in the amplitude of the H reflex and Hmax/Mmax ratio. These results suggest that the Hmax/Mmax ratio may be helpful in establishing optimum drug dosage, particularly when the drug is used on a chronic basis.
PMCID: PMC1031752  PMID: 2795085
18.  Status dystonicus resembling the intrathecal baclofen withdrawal syndrome: a case report and review of the literature 
Introduction
Status dystonicus is a rare but life-threatening disorder characterized by increasingly frequent and severe episodes of generalized dystonia that may occur in patients with primary or secondary dystonia. Painful and repetitive spasms interfere with respiration and may cause metabolic disturbances such as hyperpyrexia, dehydration, respiratory insufficiency, and acute renal failure secondary to rhabdomyolysis. Intrathecally administered baclofen, delivered by an implantable pump system, is widely used for the treatment of refractory spasticity. Abrupt cessation of intrathecal baclofen infusion has been associated with a severe withdrawal syndrome comprised of dystonia, autonomic dysfunction, hyperthermia, end-organ failure and sometimes death. The aetiology of this syndrome is not well understood. Status dystonicus describes the episodes of acute and life-threatening generalized dystonia, which occasionally manifest themselves in patients with dystonic syndromes.
Case presentation
We present the case of a nine-year-old Caucasian boy who experienced a severe episode of status dystonicus with no known cause and clinical features resembling those described in intrathecal baclofen withdrawal. Our patient subsequently underwent the placement of an intrathecal baclofen pump without incident.
Conclusion
The similarity between the clinical features of the case we present and those reported in connection to abrupt withdrawal of intrathecal baclofen is emphasized. Several drugs, although not intrathecal baclofen withdrawal, have previously been associated with status dystonicus. The similarity between the life-threatening dystonic episode experienced by our patient, and those reported in intrathecal baclofen withdrawal, highlights the possibility that, rather than representing a true physiological withdrawal syndrome, abrupt withdrawal of intrathecal baclofen may simply precipitate an episode of status dystonicus in susceptible individuals. The clinical similarities between the intrathecal baclofen withdrawal syndrome and status dystonicus have not previously been highlighted.
doi:10.1186/1752-1947-4-294
PMCID: PMC2939556  PMID: 20807402
19.  Spinal cord compression secondary to intrathecal catheter–induced granuloma: a report of four cases 
ABSTRACT
Objective: The management of nonmalignant pain by morphine pump implantation has become an effective and increasingly frequent strategy of care. We report a rare complication of intrathecal granuloma formation adjacent to the intrathecal catheter tip resulting in spinal cord compression in four patients undergoing intrathecal treatment for chronic pain.
Methods: Four patients presented with chronic back pain and lower extremity pain and weakness and were treated with morphine pump implantation (Fig 1). Each patient developed a mass at the level of the intrathecal catheter tip resulting in increased back pain and diminished neurological function. Following clinical examination and x-ray workup, the patients underwent surgical resection of the mass and removal of the intrathecal catheter. One patient received conservative saline therapy first, and another patient had granuloma resection first and removal of the intrathecal catheter at a later date. Pathological analysis showed granulation tissue with extensive necrosis and chronic inflammation, with negative culture results. No evidence of neoplasm was found.
Results: Patients showed varying degrees of improvement following removal of the intrathecal mass. Two patients had moderate pain reduction following resection of the granuloma; a third had minimal pain improvement; and a fourth had significant pain improvement but continued lower extremity weakness.
Conclusions: The formation of granulomas caused by intrathecal catheter implantation is a rare but serious complication. Imaging studies including magnetic resonance imaging with contrast and computed tomography with myelogram should be used to follow up a neurological examination consistent with spinal cord compression. Timely surgical intervention may result in marked improvement of symptoms.
doi:10.1055/s-0030-1267087
PMCID: PMC3427967  PMID: 22956937
20.  Long term effect (more than five years) of intrathecal baclofen on impairment, disability, and quality of life in patients with severe spasticity of spinal origin 
Objectives: To evaluate long term change in impairment, disability, and health related functional status in patients with severe spasticity who received intrathecal baclofen.
Methods: A long term (more than five years) observational longitudinal follow up study assessing 21 patients who received intrathecal baclofen given by programmable pump. Patients had chronic disabling spasticity which did not respond to oral antispasmolytic agents. Clinical efficacy was assessed by the Ashworth scale and spasm score; disability by the expanded disability status scale (EDSS), ambulation index (AI), and incapacity status scale (ISS); and health related quality of life by the sickness impact profile (SIP) and the Hopkins symptom checklist (HSCL).
Results: Compared with pretreatment values, there was a significant improvement in clinical efficacy (Ashworth scale and spasm score, p<0.05) but a small but significant worsening of disability (EDSS, AI, and ISS, p<0.05). Comparing pretreatment with 26 weeks after pump implantation, a worsening was observed in disability (EDSS and ISS, p<0.05) and perceived health status (SIP, psychosocial dimension, p<0.05).
Conclusions: Long term administration of intrathecal baclofen delivered by an implanted programmable pump resulted in improved clinical efficacy but not in improvement in disability or perceived health status.
doi:10.1136/jnnp.2003.014282
PMCID: PMC1738793  PMID: 15489386
21.  Treatment failure of intrathecal baclofen and supra-additive effect of nabiximols in multiple sclerosis-related spasticity: a case report 
Multiple sclerosis (MS)-related spasticity is associated with disability and impairment in quality of life. We report on a patient with secondary progressive MS and spastic tetraparesis (Expanded Disability Status Scale score 8.5). The right arm exhibited flexor spasticity resulting in functional disability despite multimodal symptomatic treatment. Intrathecal baclofen led to side effects despite decreasing efficacy. Low-dose nabiximols improved spasticity and function with recovery of daily-life activities and spasticity-related symptoms. Reduction of intrathecal baclofen ameliorated adverse drug reactions. Add-on cannabinoid therapy was effective in therapy-refractory spasticity with supra-additive effect in combining intrathecal baclofen and nabiximols, hypothetically explained by mutually complementing mechanisms of action.
doi:10.1177/1756285613475835
PMCID: PMC3625014  PMID: 23634192
cannabinoids; CB1 receptor; multiple sclerosis; nabiximols; secondary progressive multiple sclerosis; spastic tetraparesis; symptomatic treatment
22.  Selective Effects of Baclofen on Use-Dependent Modulation of GABAB Inhibition after Tetraplegia 
The Journal of Neuroscience  2013;33(31):12898-12907.
Baclofen is a GABAB receptor agonist commonly used to relief spasticity related to motor disorders. The effects of baclofen on voluntary motor output are limited and not yet understood. Using noninvasive transcranial magnetic and electrical stimulation techniques, we examined electrophysiological measures probably involving GABAB (long-interval intracortical inhibition and the cortical silent period) and GABAA (short-interval intracortical inhibition) receptors, which are inhibitory effects mediated by subcortical and cortical mechanisms. We demonstrate increased active long-interval intracortical inhibition and prolonged cortical silent period during voluntary activity of an intrinsic finger muscle in humans with chronic incomplete cervical spinal cord injury (SCI) compared with age-matched controls, whereas resting long-interval intracortical inhibition was unchanged. However, long-term (∼6 years) use of baclofen decreased active long-interval intracortical inhibition to similar levels as controls but did not affect the duration of the cortical silent period. We found a correlation between signs of spasticity and long-interval intracortical inhibition in patients with SCI. Short-interval intracortical inhibition was decreased during voluntary contraction compared with rest but there was no effect of SCI or baclofen use. Together, these results demonstrate that baclofen selectively maintains use-dependent modulation of largely subcortical but not cortical GABAB neuronal pathways after human SCI. Thus, cortical GABAB circuits may be less sensitive to baclofen than spinal GABAB circuits. This may contribute to the limited effects of baclofen on voluntary motor output in subjects with motor disorders affected by spasticity.
doi:10.1523/JNEUROSCI.1552-13.2013
PMCID: PMC3728695  PMID: 23904624
23.  Roles of Glycinergic and Gamma-aminobutyric-ergic Mechanisms in the Micturition Reflex in Rats 
Lower urinary tract symptoms  2009;1(S1):S70-S73.
The micturition reflex is one of the autonomic reflexes mediated by the spinobulbospinal reflex pathway that passes through the pontine micturition center. In the central nervous system, glutamate is a major excitatory amino acid, while glycine and gamma-aminobutyric acid (GABA) are major inhibitory neurotransmitters and act to inhibit the micturition reflex at supraspinal and/or spinal sites. Glycine and GABA have additive or synergistic inhibitory effects on bladder activity. Hypofunction of glycinergic/GABAergic mechanisms in the lumbosacral spinal cord induces voiding dysfunctions, such as detrusor overactivity (DO) or detrusor-sphincter dyssynergia (DSD) after spinal cord injury (SCI) or bladder outlet obstruction in rats. Intrathecal, intravenous, or dietary glycine inhibits both bladder and urethral activity in normal and spinal cord injury (SCI) rats. Therefore, glycine might be a useful agent for the treatment of DO. Intrathecal muscimol and baclofen (GABAA and GABAB agonists, respectively) also inhibit non-voiding bladder contractions by suppressing C-fiber bladder afferents in SCI rats. They also improve DSD by suppressing Onuf’s nucleus and C-fiber bladder afferents. Baclofen is approved for the treatment of DO in SCI patients, but this agent has not been widely used because the therapeutic window of the drug is modest and the dose is limited by side-effects. Glutamic acid decraboxylase (GAD), the GABA synthesis enzyme, gene delivery by using non-replicating herpes simplex virus (HSV) vectors inhibits DO by suppressing C-fiber bladder afferents without affecting voiding contraction in SCI rats. Therefore, GAD gene therapy can restore urine storage function without affecting voiding function; it would be more beneficial than drug therapy for the treatment of urinary problems in SCI patients.
doi:10.1111/j.1757-5672.2009.00034.x
PMCID: PMC2910440  PMID: 20676389
gamma-aminobutyric acid; gene therapy; glutamate; glutamic acid decarboxylase; glycine
24.  Evaluation of usefulness of scintigraphic imaging in diagnosis of intrathecal drug delivery system malfunction – a preliminary report 
Polish Journal of Radiology  2013;78(3):21-27.
Summary
Background:
Implantable intrathecal drug delivery systems (IDDS) are basic tool enabling chronic intrathecal pharmacotherapy. Lack of expected clinical results of IDDS therapy necessitates search for the cause with the help of diagnostic imaging methods among other things. Beside radiological techniques, it is also possible to visually assess IDDS systems by nuclear medicine methods. In this study we assess utility of radioisotopic methods in differential diagnosis of failure of therapy with IDDS systems.
Material/Methods:
Scintigraphic studies were performed in selected patients with neurological diseases associated with spasticity, who had IDDS system implanted and were unable to maintain satisfying clinical effect of inrathecally infused baclofen. After emptying the IDDS system of the drug, radiotracer (99mTc-DTPA) solution was injected into the pump reservoir. Subsequently, a series of scintigraphic images was registered, demonstrating passage and distribution of the infused radiotracer.
Results:
In all investigated cases, scintigraphic study resulted in acquiring relevant additional diagnostic information. Normal or disrupted distribution of radiotracer in spinal canal allowed for a diagnosis drug resistance or demonstrated presence of arachnoid adhesions respectively. Early appearance of radiotracer in blood was considered a proof of leak. Our examinations had decisive influence on further patient treatment, allowing for diagnosis of drug resistance in one patient or complication related to IDDS system in three other cases including breakage of a catheter, pump malfunction and arachnoid adhesions.
Conclusions:
Scintigraphic methods carry significant amount of information facilitating final diagnosis of the cause of IDDS therapy failure. They should become an important element complementing the diagnostic strategy in patients with suspected failure of intrathecal drug administration systems. Interpretation of radioisotopic studies, since they are purely functional, must be performed in strict relation to clinical data and radiological examinations as they carry indispensable, basic information regarding morphology.
doi:10.12659/PJR.889130
PMCID: PMC3789929  PMID: 24115956
intrathecal drug delivery system; intrathecal baclofen; intrathecal; baclofen; scintigraphy; 99mTc-DTPA
25.  Status Epilepticus After Baclofen Withdrawal 
Baclofen is widely used in the treatment of spasticity of spinal origin. It is relatively free of side effects or toxic actions on the nervous system or other organs. Agitation, personality change, and auditory and visual hallucinations have been described following its abrupt withdrawal. One patient with generalized seizures and one with complex partial seizures after baclofen withdrawal have been reported. This paper presents a patient who developed status epilepticus after baclofen withdrawal, and who sustained hypoxic cerebral injury. This observation further emphasizes the possibility of infrequent complications of baclofen therapy, and the advisability of gradual changes in baclofen dosage.
PMCID: PMC2561766  PMID: 6737510

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