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1.  Levetiracetam in the preventive treatmentof transformed migraine: A prospective, open-label, pilot study 
Background:
Most preventive agents used for transformed migraine (TM)have not been studied specifically for the treatment of this syndrome. Open-label trials have demonstrated the effectiveness of levetiracetam in the treatment of refractory headaches.
Objective:
The aim of this study was to assess the effectiveness and tolerabilityof levetiracetam in the preventive treatment of refractory TM.
Methods:
This prospective, open-label, pilot study was conducted at TheNew England Center for Headache, Stamford, Connecticut. We included patients aged ≥ 18 years with refractory TM according to the criteria proposed by Silberstein et al. All participants had failed on at least 1 but not more than 3 preventive drugs. Other preventive drugs were allowed if they had been received at a stable dose for > 30 days. The dosage of the levetiracetam tablets ranged from 1000 to 3000 mg/d in 2 divided doses. The treatment phase lasted 3 months. The primary end point was headache frequency (expressed as the number of headache days per month), and the secondary end point was the frequency of moderate or severe headache (d/mo). Other end points were headache score, Migraine Disability Assessment (MIDAS) Questionnaire score, and Headache Impact Test (HIT-6) score. Statistical analyses were performed in the intent-to-treat (ITT) population (patients who received at least 1 dose of study medication) using data subjected to the last-observation-carried-forward algorithm. We also conducted per-protocol (PP) analyses in patients who completed the study.
Results:
The ITT population consisted of 36 patients (26 women, 10 men;mean [SD] age, 46.5 [17.4] years). The mean headache frequency at baseline was 24.9 d/mo, and a significant reduction in headache frequency was obtained at l, 2, and 3 months of treatment (19.4, 18.4, and 16.2 d/mo, respectively; all, P < 0.001 Reproduction in whole or part is not permitted. vs baseline). At baseline, the mean number of moderate or severe headache days was 16.8 d/mo compared with 13.2, 11.9, and 9.7 d/mo at 1, 2, and 3 months, respectively (P=NS, <0.01, and <0.01, respectively). The mean MIDAS score was significantly reduced at 3 months compared with baseline (40.8 vs 62.8 d/mo; P = 0.01). The mean HIT-6 score was 59.4 at 3 months versus 63.4 at baseline (P < 0.01). In the PP population, the mean (SD) headache frequency was reduced from 26.1 (4.1) d/mo at baseline to 14.3 (4.8) d/mo at the end of the study (P < 0.001). The mean (SD) headache score was reduced from 51.3 (17.1) at baseline to 34.0 (22.0) at 3 months (P < 0.016).
Conclusion:
The results of this study in patients with TM support the role of levetiracetam in the preventive treatment of refractory TM.
doi:10.1016/j.curtheres.2005.06.006
PMCID: PMC3964555  PMID: 24672124
levetiracetam; transformed migraine; chronic daily headache; preventive treatment; prevention
2.  Sleep Onset/Maintenance Difficulties and Cognitive Function in Nondemented Older Adults: the Role of Cognitive Reserve 
Background
This study examined the relationship between cognitive function and sleep onset/maintenance difficulties (SO/MD) in nondemented older adults. We hypothesized that SO/MD negatively impacts cognition and that older adults with lower education would be especially vulnerable to its effects.
Methods
The sample comprised 549 older adults from the Einstein Aging Study (EAS), a community-based sample. Participants completed neuropsychological assessment and a sleep questionnaire. Univariate ANCOVAs were performed with cognitive performance as a dependent variable, SO/MD (present or absent) and education (lower:≤12 years; higher:>12 years) as between-subjects factors, and age, ethnicity, gender, depression, and cardiovascular comorbidies as covariates.
Results
Participants were an average age of 79.7±5.0 years (range=71–97). Fifty-seven percent (n=314) of the sample met criteria for SO/MD. Among participants with SO/MD, those with lower education performed more poorly on a test of category fluency than participants with higher education (means: 35.2 vs. 41.0, p<0.001); among older adults without SO/MD, educational attainment had no measurable effect on cognition (SO/MD × education interaction (F(1,536)=14.5, p=0.00)).
Conclusions
Consistent with the cognitive reserve hypothesis, older adults with lower education appear selectively vulnerable to the negative effects of sleep onset/maintenance difficulties on tests of verbal fluency.
doi:10.1017/S1355617711001901
PMCID: PMC3682475  PMID: 22317892
Sleep; Neuropsychology; Cognitive Reserve; Elderly; Education; Depression
3.  Migraine and behavior in children: influence of maternal headache frequency 
The Journal of Headache and Pain  2012;13(5):395-400.
We took advantage of a large population study in order to measure child behavior, as captured by the Child Behavior Checklist (CBCL) as a function of headache status in the children and their mothers. Of the target sample, consents and analyzable data were obtained from 1,856 families (85.4 %). Headache diagnoses were defined according to the second edition of the International Classification of Headache Disorders, and behavioral and emotional symptoms were assessed by the validated Brazilian version of the CBCL. We calculated the relative risk of abnormalities in the CBCL domains as a function of headache status in the children, after adjusting by a series of main effect models. Children with migraine were more likely to present abnormal scores in several of the CBCL scales, relative to children without migraine, and maternal migraine status contributed little to the model. However, when the mother had daily headaches, both children with and without migraine had similar CBCL scores. In multivariate analyses, migraine status in the children predicted CBCL scores (p < 0.01). Headache status and headache frequency in the mother did not predict CBCL scores in children with migraine but predicted in children without migraine (p < 0.01). The burden of migraine to the family is complex. Children with migraine are more likely to have behavioral and emotional symptoms than children without migraine. Children without migraine may be affected, in turn, by frequent headaches experienced by their mothers.
doi:10.1007/s10194-012-0441-x
PMCID: PMC3381068  PMID: 22460944
Headache; Migraine; Psychiatric comorbidity; Maternal headache; Childhood; Epidemiology
4.  Topiramate plus nortriptyline in the preventive treatment of migraine: a controlled study for nonresponders 
A sizeable proportion of migraineurs in need of preventive therapy do not significantly benefit from monotherapy. The objective of the study is to conduct a randomized controlled trial testing whether combination therapy of topiramate and nortriptyline is useful in patients who had less than 50% decrease in headache frequency with the use of the single agents. Patients with episodic migraine were enrolled if they had less than 50% reduction in headache frequency after 8 weeks of using topiramate (TPM) (100 mg/day) or nortriptyline (NTP) (30 mg/day). They were randomized (blinded fashion) to have placebo added to their regimen, or to receive the second medication (combination therapy). Primary endpoint was decrease in number of headache days at 6 weeks, relative to baseline, comparing both groups. Secondary endpoint was proportion of patients with at least 50% reduction in headache frequency at 6 weeks relative to baseline. A total of 38 patients were randomized to receive combination therapy, while 30 continued on monotherapy (with placebo) (six drop outs in the combination group and three for each single drug group). For the primary endpoint, mean and standard deviation (SD) of reduction in headache frequency were 4.6 (1.9) for those in polytherapy, relative to 3.5 (2.3) for those in monotherapy. Differences were significant (p < 0.05]. Similarly, 78.3% of patients randomized to receive polytherapy had at least 50% headache reduction, as compared to 37% in monotherapy (p < 0.04). Finally we conclude that combination therapy (of TPM and NTP) is effective in patients with incomplete benefit using these agents in monotherapy.
doi:10.1007/s10194-011-0395-4
PMCID: PMC3253150  PMID: 22008899
Topiramate; Nortriptyline; Migraine; Prevention; Combination; Therapy
5.  Topiramate plus nortriptyline in the preventive treatment of migraine: a controlled study for nonresponders 
A sizeable proportion of migraineurs in need of preventive therapy do not significantly benefit from monotherapy. The objective of the study is to conduct a randomized controlled trial testing whether combination therapy of topiramate and nortriptyline is useful in patients who had less than 50% decrease in headache frequency with the use of the single agents. Patients with episodic migraine were enrolled if they had less than 50% reduction in headache frequency after 8 weeks of using topiramate (TPM) (100 mg/day) or nortriptyline (NTP) (30 mg/day). They were randomized (blinded fashion) to have placebo added to their regimen, or to receive the second medication (combination therapy). Primary endpoint was decrease in number of headache days at 6 weeks, relative to baseline, comparing both groups. Secondary endpoint was proportion of patients with at least 50% reduction in headache frequency at 6 weeks relative to baseline. A total of 38 patients were randomized to receive combination therapy, while 30 continued on monotherapy (with placebo) (six drop outs in the combination group and three for each single drug group). For the primary endpoint, mean and standard deviation (SD) of reduction in headache frequency were 4.6 (1.9) for those in polytherapy, relative to 3.5 (2.3) for those in monotherapy. Differences were significant (p < 0.05]. Similarly, 78.3% of patients randomized to receive polytherapy had at least 50% headache reduction, as compared to 37% in monotherapy (p < 0.04). Finally we conclude that combination therapy (of TPM and NTP) is effective in patients with incomplete benefit using these agents in monotherapy.
doi:10.1007/s10194-011-0395-4
PMCID: PMC3253150  PMID: 22008899
Topiramate; Nortriptyline; Migraine; Prevention; Combination; Therapy
6.  Chronic Pain and Obesity in the Elderly: Results from the Einstein Aging Study 
OBJECTIVES
To determine the prevalence of chronic pain in the elderly and its relationship with obesity, associated co-morbidities and risk factors.
DESIGN
Cross-Sectional
SETTING
Community-based
PARTICIPANTS
A representative community sample of 840 elderly subjects age 70 or older.
MEASUREMENTS
We examined the prevalence of chronic pain and its relationship with obesity (categories defined by body mass index), other medical risk factors and psychiatric comorbidities. Chronic pain was defined by pain of at least moderate severity (≥ 4 on a 10-point scale) some, most or all of the time for the past three months.
RESULTS
The sample was mostly female (62.8%) and the average age was 80 years (range 70–101 years). The prevalence of chronic pain was 52% (39.7% in men; 58.9% in women). Those with chronic pain were more likely to report a diagnosis of depression (OR 2.5, 95%CI=1.40–4.55) and anxiety (OR 2.3, 95%CI=1.22–4.64). Compared to individuals with normal weight (BMI 18.5–24.9), obese subjects (BMI 30–34.9) were twice as likely (OR 2.1, 95%CI=1.33–3.28) while severely obese subjects (BMI ≥ 35) were more than four times as likely (OR 4.5, 95%CI=1.85–12.63) to have chronic pain. Obese subjects were significantly more likely to have chronic pain in the head, neck/shoulder, back, legs/feet, and abdomen/pelvis than non-obese subjects. In multivariate models, obesity (OR 2.0, 95%CI=1.27–3.26) and severe obesity (OR 4.1, 95%CI=1.57–10.82) were associated with chronic pain after adjusting for age, sex, diabetes, hypertension, depression, anxiety and education.
CONCLUSION
Chronic pain is common in this elderly population, affects women more than men and is highly associated with obesity.
doi:10.1111/j.1532-5415.2008.02089.x
PMCID: PMC2763486  PMID: 19054178
Chronic Pain; Obesity; Elderly
7.  The differential diagnosis of chronic daily headaches: an algorithm-based approach 
The Journal of Headache and Pain  2007;8(5):263-272.
Chronic daily headaches (CDHs) refers to primary headaches that happen on at least 15 days per month, for 4 or more hours per day, for at least three consecutive months. The differential diagnosis of CDHs is challenging and should proceed in an orderly fashion. The approach begins with a search for “red flags” that suggest the possibility of a secondary headache. If secondary headaches that mimic CDHs are excluded, either on clinical grounds or through investigation, the next step is to classify the headaches based on the duration of attacks. If the attacks last less than 4 hours per day, a trigeminal autonomic cephalalgia (TAC) is likely. TACs include episodic and chronic cluster headache, episodic and chronic paroxysmal hemicrania, SUNCT, and hypnic headache. If the duration is ≥4 h, a CDH is likely and the differential diagnosis encompasses chronic migraine, chronic tension-type headache, new daily persistent headache and hemicrania continua. The clinical approach to diagnosing CDH is the scope of this review.
doi:10.1007/s10194-007-0418-3
PMCID: PMC2793374  PMID: 17955166
Chronic daily headache; Differential diagnosis; Strategy
8.  Is there an inherent limit to acute migraine treatment efficacy? 
The Journal of Headache and Pain  2009;10(6):393-394.
doi:10.1007/s10194-009-0162-y
PMCID: PMC3476204  PMID: 19820895
9.  Migraine and cardiovascular disease: systematic review and meta-analysis 
Objective To evaluate the association between migraine and cardiovascular disease, including stroke, myocardial infarction, and death due to cardiovascular disease.
Design Systematic review and meta-analysis.
Data sources Electronic databases (PubMed, Embase, Cochrane Library) and reference lists of included studies and reviews published until January 2009.
Selection criteria Case-control and cohort studies investigating the association between any migraine or specific migraine subtypes and cardiovascular disease.
Review methods Two investigators independently assessed eligibility of identified studies in a two step approach. Disagreements were resolved by consensus. Studies were grouped according to a priori categories on migraine and cardiovascular disease.
Data extraction Two investigators extracted data. Pooled relative risks and 95% confidence intervals were calculated.
Results Studies were heterogeneous for participant characteristics and definition of cardiovascular disease. Nine studies investigated the association between any migraine and ischaemic stroke (pooled relative risk 1.73, 95% confidence interval 1.31 to 2.29). Additional analyses indicated a significantly higher risk among people who had migraine with aura (2.16, 1.53 to 3.03) compared with people who had migraine without aura (1.23, 0.90 to 1.69; meta-regression for aura status P=0.02). Furthermore, results suggested a greater risk among women (2.08, 1.13 to 3.84) compared with men (1.37, 0.89 to 2.11). Age less than 45 years, smoking, and oral contraceptive use further increased the risk. Eight studies investigated the association between migraine and myocardial infarction (1.12, 0.95 to 1.32) and five between migraine and death due to cardiovascular disease (1.03, 0.79 to 1.34). Only one study investigated the association between women who had migraine with aura and myocardial infarction and death due to cardiovascular disease, showing a twofold increased risk.
Conclusion Migraine is associated with a twofold increased risk of ischaemic stroke, which is only apparent among people who have migraine with aura. Our results also suggest a higher risk among women and risk was further magnified for people with migraine who were aged less than 45, smokers, and women who used oral contraceptives. We did not find an overall association between any migraine and myocardial infarction or death due to cardiovascular disease. Too few studies are available to reliably evaluate the impact of modifying factors, such as migraine aura, on these associations.
doi:10.1136/bmj.b3914
PMCID: PMC2768778  PMID: 19861375
10.  Cutaneous Allodynia in the Migraine Population 
Annals of neurology  2008;63(2):148-158.
Objective
To develop and validate a questionnaire for assessing cutaneous allodynia (CA), and to estimate the prevalence and severity of CA in the migraine population.
Methods
Migraineurs (n = 11,388) completed the Allodynia Symptom Checklist, assessing the frequency of allodynia symptoms during headache. Response options were never (0), rarely (0), less than 50% of the time (1), ≥50% of the time (2), and none (0). We used item response theory to explore how well each item discriminated CA. The relations of CA to headache features were examined.
Results
All 12 questions had excellent item properties. The greatest discrimination occurred with CA during “taking a shower” (discrimination = 2.54), wearing a necklace (2.39) or ring (2.31), and exposure to heat (2.1) or cold (2.0). The factor analysis demonstrated three factors: thermal, mechanical static, and mechanical dynamic. Based on the psychometrics, we developed a scale distinguishing no CA (scores 0–2), mild (3–5), moderate (6–8), and severe (≥9). The prevalence of allodynia among migraineurs was 63.2%. Severe CA occurred in 20.4% of migraineurs. CA was associated with migraine defining features (eg, unilateral pain: odds ratio, 2.3; 95% confidence interval, 2.0 –2.4; throbbing pain: odds ratio, 2.3; 95% confidence interval, 2.1–2.6; nausea: odds ratio, 2.3; 95% confidence interval, 2.1–2.6), as well as illness duration, attack frequency, and disability.
Interpretation
The Allodynia Symptom Checklist measures overall allodynia and subtypes. CA affects 63% of migraineurs in the population and is associated with frequency, severity, disability, and associated symptoms of migraine. CA maps onto migraine biology.
doi:10.1002/ana.21211
PMCID: PMC2729495  PMID: 18059010
11.  Chronic disorders with episodic manifestations: focus on epilepsy and migraine 
Lancet neurology  2006;5(2):148-157.
Epilepsy and migraine are chronic neurological disorders with episodic manifestations that are commonly treated in neurological practice and frequently occur together. In this review we examine similarities and contrasts between these disorders, with focus on epidemiology and classification, temporal coincidence, triggers, and mechanistically based therapeutic overlap. This investigation draws attention to unique aspects of both epilepsy and migraine, while identifying areas of crossover in which each specialty could benefit from the experience of the other.
doi:10.1016/S1474-4422(06)70348-9
PMCID: PMC1457022  PMID: 16426991
12.  The differential diagnosis of chronic daily headaches: an algorithm-based approach 
The Journal of Headache and Pain  2007;8(5):263-272.
Chronic daily headaches (CDHs) refers to primary headaches that happen on at least 15 days per month, for 4 or more hours per day, for at least three consecutive months. The differential diagnosis of CDHs is challenging and should proceed in an orderly fashion. The approach begins with a search for “red flags” that suggest the possibility of a secondary headache. If secondary headaches that mimic CDHs are excluded, either on clinical grounds or through investigation, the next step is to classify the headaches based on the duration of attacks. If the attacks last less than 4 hours per day, a trigeminal autonomic cephalalgia (TAC) is likely. TACs include episodic and chronic cluster headache, episodic and chronic paroxysmal hemicrania, SUNCT, and hypnic headache. If the duration is ≥4 h, a CDH is likely and the differential diagnosis encompasses chronic migraine, chronic tension-type headache, new daily persistent headache and hemicrania continua. The clinical approach to diagnosing CDH is the scope of this review.
doi:10.1007/s10194-007-0418-3
PMCID: PMC2793374  PMID: 17955166
Chronic daily headache; Differential diagnosis; Strategy
13.  Overview on the prevalence and impact of migraine 
The Journal of Headache and Pain  2004;5(Suppl 2):s88-s91.
Migraine is a highly prevalent headache disorder that has a substantial impact on the individual and society. Over the past decade, substantial advances in research have increased understanding of the pathophysiology, diagnosis, epidemiology, and treatment of the disorder. This article reviews the burden of migraine, emphasizing the population-based studies that used standardized diagnostic criteria.
doi:10.1007/s10194-004-0117-2
PMCID: PMC3451580
Migraine; Epidemiology; Impact
14.  A new questionnaire for assessment of adverse events associated with triptans: methods of assessment influence the results. Preliminary results 
The Journal of Headache and Pain  2004;5(Suppl 2):s112-s116.
Triptans are the treatment of choice for migraine sufferers with disabling attacks. However, the proportion of patients reporting side effects after any acute treatment may vary in regard to the method of assessment. This study was conducted in a neurology office focusing on headache in Italy. We prospectively surveyed adult headache sufferers who had been using the same triptan for at least 3 months (from March 2001 to May 2003). Participants were asked about their headache and treatment history. Subjects then completed a standardized questionnaire, assessing adverse events in two different ways. First, subjects were asked if they had any adverse events when using the triptan. If they answered yes, they were asked to list them and grade their severity as mild, moderate, or severe. After returning the first part of the questionnaire, subjects received a second form, where 49 possible adverse events were listed. Most of them were known triptan side effects; some confounders (side effects not expected to be related with triptan use) were added. We contrasted and correlated both sets of answers. We surveyed 108 subjects, (87.1% female, mean age 39.5 years). Most patients (65.5%) reported no side effects in the unprompted questionnaire. However, most of them (54.1%) reported at least one side effect in the prompted questionnaire. The majority of patients that reported side effects in the unprompted questionnaire said they had only one adverse event, while most reported two or more side effects in the prompted questionnaire. Both in the unprompted and in the prompted questionnaires, most side effects were rated as mild or moderate. Two (1.9%) subjects graded their adverse events as severe in the prompted questionnaire, but had not self-reported them. We conclude that when assessing the adverse events of triptans (or any class of medication), the method of data collection may dramatically influence the results.
doi:10.1007/s10194-004-0123-4
PMCID: PMC3451596
Triptans; Adverse events; Methods of assessment
15.  The global burden of migraine 
The Journal of Headache and Pain  2003;4(Suppl 1):s3-s11.
Migraine is a highly prevalent headache disorder that has a substantial impact on the individual and on society. Over the past decade, substantial advances in research have increased understanding of the pathophysiology, diagnosis, epidemiology, and treatment of the disorder. This article reviews the burden of migraine, emphasizing population-based studies that used standardized diagnostic criteria. We highlight descriptive epidemiology, burden of disease, patterns of diagnosis and treatment, as well as approaches to improving health care delivery for migraine.
doi:10.1007/s101940300001
PMCID: PMC3611680
Key words Migraine; Epidemiology; Impact

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