Susan L. LeCates

PedMIDAS Development of a questionnaire to assess disability of migraines in children

BackgroundFor adults, disability produced by migraines has been assessed with a migraine-specific disability tool—MIDAS. The objective of this study was to develop and validate a similar tool that accurately depicts the disability of headaches in school-age children and adolescents. MethodsA six-question tool (PedMIDAS) was developed and administered to patients attending a tertiary referral center for pediatric headaches. Internal consistency and test/retest reliability were assessed. Validity was assessed by correlating scores with headache frequency, severity, and duration. Changes in the total score in response to treatment were assessed in a portion of the patients. ResultsThe PedMIDAS questionnaire was administered to 441 patients for a total of 724 trials. The mean score at the initial visit was 44.3 ± 47.9, whereas the overall mean score was 25.1 ± 36.5. A 2-week test/retest reliability assessment for 56 patients confirmed the stability of the instrument with a Pearson coefficient of 0.80. The correlation of the PedMIDAS score with frequency, severity, and duration had Pearson’s coefficient values of 0.58, 0.27, and 0.23. The PedMIDAS score was reduced to 20.0 ± 32.3 (p < 0.0001) at the first follow-up assessment with subsequent continued reduction. ConclusionsThe PedMIDAS questionnaire provided a developmentally sensitive, reliable, and valid assessment of the disability of childhood and adolescent headaches. This questionnaire provides a tool to assess the impact of migraines in children and to monitor response to treatment. Further research should focus on additional validation of the PedMIDAS using a larger population and sampling from other populations (e.g., primary care and community samples).

Coenzyme Q10 deficiency and response to supplementation in pediatric and adolescent migraine.

Background.—Coenzyme Q10 (CoQ10) has been suggested to be effective in the prevention of migraine, and levels can be quantified with standardized reference ranges.

Cognitive Behavioral Therapy Plus Amitriptyline for Chronic Migraine in Children and Adolescents A Randomized Clinical Trial

IMPORTANCE Early, safe, effective, and durable evidence-based interventions for children and adolescents with chronic migraine do not exist. OBJECTIVE To determine the benefits of cognitive behavioral therapy (CBT) when combined with amitriptyline vs headache education plus amitriptyline. DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial of 135 youth (79% female) aged 10 to 17 years diagnosed with chronic migraine (≥15 days with headache/month) and a Pediatric Migraine Disability Assessment Score (PedMIDAS) greater than 20 points were assigned to the CBT plus amitriptyline group (n = 64) or the headache education plus amitriptyline group (n = 71). The study was conducted in the Headache Center at Cincinnati Childrens Hospital between October 2006 and September 2012; 129 completed 20-week follow-up and 124 completed 12-month follow-up. INTERVENTIONS Ten CBT vs 10 headache education sessions involving equivalent time and therapist attention. Each group received 1 mg/kg/d of amitriptyline and a 20-week end point visit. In addition, follow-up visits were conducted at 3, 6, 9, and 12 months. MAIN OUTCOMES AND MEASURES The primary end point was days with headache and the secondary end point was PedMIDAS (disability score range: 0-240 points; 0-10 for little to none, 11-30 for mild, 31-50 for moderate, >50 for severe); both end points were determined at 20 weeks. Durability was examined over the 12-month follow-up period. Clinical significance was measured by a 50% or greater reduction in days with headache and a disability score in the mild to none range (<20 points). RESULTS At baseline, there were a mean (SD) of 21 (5) days with headache per 28 days and the mean (SD) PedMIDAS was 68 (32) points. At the 20-week end point, days with headache were reduced by 11.5 for the CBT plus amitriptyline group vs 6.8 for the headache education plus amitriptyline group (difference, 4.7 [95% CI, 1.7-7.7] days; P = .002). The PedMIDAS decreased by 52.7 points for the CBT group vs 38.6 points for the headache education group (difference, 14.1 [95% CI, 3.3-24.9] points; P = .01). In the CBT group, 66% had a 50% or greater reduction in headache days vs 36% in the headache education group (odds ratio, 3.5 [95% CI, 1.7-7.2]; P < .001). At 12-month follow-up, 86% of the CBT group had a 50% or greater reduction in headache days vs 69% of the headache education group; 88% of the CBT group had a PedMIDAS of less than 20 points vs 76% of the headache education group. Measured treatment credibility and integrity was high for both groups. CONCLUSIONS AND RELEVANCE Among young persons with chronic migraine, the use of CBT plus amitriptyline resulted in greater reductions in days with headache and migraine-related disability compared with use of headache education plus amitriptyline. These findings support the efficacy of CBT in the treatment of chronic migraine in children and adolescents. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00389038.

Effectiveness of Topiramate in the Prevention of Childhood Headaches

Background.—Migraine is a significant problem for many children. Topiramate has been suggested to be effective for the prophylaxis of migraine in adults, but has not yet been examined in children. The drug has been demonstrated to be safe and effective for childhood seizure disorders. The objective of this study was to demonstrate the safety and efficacy of topiramate for the prevention of pediatric migraine.

Development of a patient-based grading scale for PedMIDAS.

The objective was to develop and validate a patient-based grading scale for PedMIDAS. PedMIDAS was administered to 329 children, who rated their overall disability based on the adult MIDAS grades. This patient-based rating and PedMIDAS scores were compared to develop the grading scale. Headache disability was rated little to none, 49.5%; mild, 26.7%; moderate, 15.8%; and severe, 7.9%, with PedMIDAS raw scores of 4.9 ± 6.3, 17.8 ± 14.9, 40.6 ± 34.2, and 91.4 ± 69.8. Convergence of these results yielded an empirically derived grading system: Grade I, 0-10; II, 11-30; III, 31-50 and IV, > 50. Higher grades corresponded to an increased need for prophylactic treatment. A patient-based grading scale further increases the utility of PedMIDAS in assessing migraine disability in children, so that it can be widely used in routine clinical evaluation and management.

Characterization of chronic daily headaches in children in a multidisciplinary headache center

Background: Chronic daily headaches (CDH) occur in >4% of the adult population. The criteria for CDH, however, are controversial. In children, the characterization of frequent headaches and CDH is limited. Methods: A Headache Center to characterize headaches in children (3 to 18 years old) was established. Over 34 months, 577 children have been evaluated. With use of a definition of ≥15 headaches per month, 200 (34.6%) children had CDH. Results: The average age at the first headache in these children was 9.3 ± 3.6 years, whereas the average age at presentation to the Headache Center was 12.5 ± 3.1 years. Sixty-eight percent were girls, 88% were Caucasian, and 11% were African American. Ninety-two percent clinically had migraine headaches, whereas 60.5% met the International Headache Society migraine criteria. The pain was pulsatile in 79%, 63.5% had nausea with or without vomiting, and 59.5% had photophobia and phonophobia. Three subcategories emerged, with 37% having frequent headaches but not daily, 43.5% having episodic daily headaches, and 19.5% having a continuous headache. Conclusion: The features of CDH in children most closely match those of migraine. A clear division of these children using frequency identifies three groups: frequent headaches (15 to 29), daily intermittent, and daily continuous. The daily continuous group is the most unique; however, the nature of these headaches continues to remain migrainous.

Tolerability and Effectiveness of Prochlorperazine for Intractable Migraine in Children

Objective. To study the effectiveness of prochlorperazine in aborting severe, intractable migraines in children. Study Design. Patients for this study were drawn from the population seen and evaluated in the Headache Center at Cincinnati Childrens Hospital Medical Center. All patients were diagnosed with migraine headache by both clinical and International Headache Society criteria. The effectiveness of intravenous prochlorperazine in 20 consecutive patients referred to the emergency department for severe, prolonged migraines was retrospectively reviewed. Results. Patients evaluated in this study presented with a mean headache severity of 8.4 on a 0- to 10-point scale and an average duration of 54 hours. At 1 hour, 90% of the patients reported feeling better with 50% becoming pain-free. A 50% or greater reduction in severity occurred in 75% of patients at 1 hour and in 95% at 3 hours. At 3 hours, 95% of the patients reported feeling better, and 60% were pain-free. Only 1 patient failed to respond to prochlorperazine. Conclusion. Prochlorperzaine was shown to be highly effective in aborting intractable migraines in children. It was well tolerated with no significant side effects. Additional large, double-blinded, randomized, placebo-controlled studies are needed to further investigate its effectiveness.

A randomized, double-blinded, placebo-controlled, crossover, add-on study of CoEnzyme Q10 in the prevention of pediatric and adolescent migraine.

Objective: To evaluate the efficacy of Coenzyme Q10 (CoQ10) supplementation in the prevention of migraine in children using a placebo-controlled, double-blinded, crossover, add-on trial. Background: CoQ10 has been demonstrated to have efficacy in migraine prevention in adults but lacks pediatric research with more rigorous methodology. CoQ10 has been observed to be deficient in a significant number of children and adolescents presenting to tertiary headache centers. CoQ10 has the potential to modify both the inflammatory changes that occur during recurrent migraine and the alteration of mitochondrial function. A deficit of CoQ10 could thus affect the response to treatment and clinical characteristics of migraine in children and adults. Methods: One-hundred-and-twenty children and adolescents with migraine headache were randomized in a crossover, double-blind, placebo-controlled, randomized, add-on study to receive a placebo or CoQ10 (100 mg) supplement for 224 days. Data for 76 patients were available at the crossover point and 50 were analysed at the endpoint. Response to treatment, overall headache improvement, and headache disability were assessed. Results: Both the placebo and CoQ10 groups showed reduced migraine frequency [F(1, 60) = 15.68, p < 0.001], severity [F(1, 54) = 8.09, p = 0.006], and duration [F(1, 45) = 6.27, p = 0.016] over time. CoQ10 treated patients had a significantly greater improvement in frequency from subject reported baseline starting within 4 weeks of initiation. No group differences comparing the first 4 weeks of treatment with the last 4 weeks of treatment were found in migraine frequency [F(1, 60) = 2.34, p > 0.05], severity [F(1, 54) = 0.06, p > 0.05], or duration [F(1, 45) = 0.14, p > 0.05]. Conclusions: Overall, results of the study demonstrate that children and adolescents with migraine improved over time with multidisciplinary, standardized treatment regardless of supplementation with CoQ10 or placebo. There was no difference in headache outcomes between the CoQ10 and placebo groups at day 224. Due to the improvements seen in weeks 1–4, CoQ10 may lead to earlier improvement in headache severity, but given the sample size this conclusion warrants further investigation with a larger sample.

Inpatient Treatment of Status Migraine With Dihydroergotamine in Children and Adolescents

Objective.— To assess the effectiveness of aggressive therapy of status migraine in children and adolescents.

Outcome of a multidisciplinary approach to pediatric migraine at 1, 2, and 5 years.

Objective.—To assess the long‐term effectiveness and outcome of multidisciplinary treatment of childhood headaches 1, 2, and 5 years after initial treatment.