Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches

Study Overview
=================
Brief Summary
-----------------
Cranial electrotherapy stimulation (CES) may be a safe adjunct to medical treatment for pain relief in migraine patients. However, despite the number of CES studies done, many have been open label, single blinded, or have utilized a small group of patients.

Detailed Description
-----------------
This study will evaluate the efficacy of the Fisher Wallace Cranial Stimulator in persons with chronic migraine who have not achieved satisfactory pain control on their current medications.

Official Title
-----------------
Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Device: Cranial Electrostimulator
* Device: Sham Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects satisfying the IHS (International Headache Society) criteria for migraine Subjects have not achieved satisfactory pain control on their current medication Ability to maintain a daily headache diary Stable medication use related to migraine for at least 4 weeks prior to enrollment in the study Exclusion Criteria: Previous exposure to or experience with cranial electrotherapy stimulation (CES) Contraindications to Fisher Wallace stimulator, such as cardiac pacemakers or implantable defibrillators, known or suspected heart disease, or pregnancy Seizure disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cranial Electrostimulator<br>wears active cranial electrostimulation device for 20 minutes daily for 28 days | Device: Cranial Electrostimulator<br>* participant wears active cranial electrostimulation device for 20 minutes daily for 28 days<br>* Other names: Fisher Wallace Cranial Electrostimulator;|
| Sham Comparator: Sham device<br>wears sham device for 20 minutes daily for 28 days | Device: Sham Device<br>* participant wears sham device for 20 minutes daily for 28 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Headache Days | Mean change in headache days between 28 day run-in month and 28 day blinded month, i.e. run-in month mean minus blinded month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache). | 28 day period during run-in month and blinded month | 
| Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9) | Mean difference of PHQ-9 score between the run-in month and blinded month, i.e. PHQ-9 score from run-in month minus blinded month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms. | 14 days recall; measured at end of run-in month and blinded month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Days | Mean change in headache days between 28 day run-in month and 28 day open label month, i.e. run-in month mean minus open label month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache). | 28 day period in run-in month and open label month | 
| Depression Score (Patient Health Questionnaire-9) | Mean difference of PHQ-9 score between the run-in month and open label month, i.e. PHQ-9 score from run-in month minus open label month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms. | 14 day recall, recorded at the end of run-in and open label months | 
| Headache Impact Test-6 | Mean difference in HIT-6 score between run-in month and blinded month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability. | after run-in month, after blinded month | 
| Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches) | Mean difference in HIT-6 score between run-in month and open label month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability. | 28 day period in run-in month and open label month | 
| Generalized Anxiety Disorder Score (GAD 7) | Mean difference in GAD 7 score between run-in month and blinded month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety | 14 days recall; measured at end of run-in month and blinded month | 
| Generalized Anxiety Disorder Score (GAD 7) | Mean difference in GAD 7 score between run-in month and open label month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety | 14 day recall, recorded at the end of run-in and open label months | 
| Somatic Symptom Severity (Patient Health Questionnaire 15) | Mean difference in PHQ 15 score between run-in month and blinded month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 (not bothered at all) to 2 (bothered a lot). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms | 28 days recall; measured at end of run-in month and blinded month | 
| Somatic Symptom Score (Patient Health Questionnaire-15) | Mean difference in PHQ 15 score between run-in month and open label month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 (not bothered at all) to 2 (bothered a lot). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms. | 28 day period in run-in month and open label month | 
| Epworth Sleepiness Scale Score | Mean difference of Epworth Sleepiness Scale score between run-in month and blinded month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in recent times. The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep. | recorded at the end of run-in month and blinded month | 
| Epworth Sleepiness Scale Score | Mean difference of Epworth Sleepiness Scale score between run-in month and open label month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in recent times. The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep. | Score recorded at the end of run-in and open label month |