Back to resultsCranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cranial Electrostimulator
Sham Device
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
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
Sites / Locations
- University of Toledo, Health Science Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Cranial Electrostimulator
Sham device
Arm Description
wears active cranial electrostimulation device for 20 minutes daily for 28 days
wears sham device for 20 minutes daily for 28 days
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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).
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.
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.
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.
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
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
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
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.
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.
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.
Full Information
NCT ID
NCT01265797
First Posted
December 15, 2010
Last Updated
February 2, 2015
Sponsor
University of Toledo Health Science Campus
1. Study Identification
Unique Protocol Identification Number
NCT01265797
Brief Title
Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
Official Title
Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toledo Health Science Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cranial Electrostimulator
Arm Type
Active Comparator
Arm Description
wears active cranial electrostimulation device for 20 minutes daily for 28 days
Arm Title
Sham device
Arm Type
Sham Comparator
Arm Description
wears sham device for 20 minutes daily for 28 days
Intervention Type
Device
Intervention Name(s)
Cranial Electrostimulator
Other Intervention Name(s)
Fisher Wallace Cranial Electrostimulator
Intervention Description
participant wears active cranial electrostimulation device for 20 minutes daily for 28 days
Intervention Type
Device
Intervention Name(s)
Sham Device
Intervention Description
participant wears sham device for 20 minutes daily for 28 days
Primary Outcome Measure Information:
Title
Mean Headache Days
Description
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).
Time Frame
28 day period during run-in month and blinded month
Title
Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9)
Description
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.
Time Frame
14 days recall; measured at end of run-in month and blinded month
Secondary Outcome Measure Information:
Title
Headache Days
Description
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).
Time Frame
28 day period in run-in month and open label month
Title
Depression Score (Patient Health Questionnaire-9)
Description
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.
Time Frame
14 day recall, recorded at the end of run-in and open label months
Title
Headache Impact Test-6
Description
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.
Time Frame
after run-in month, after blinded month
Title
Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches)
Description
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.
Time Frame
28 day period in run-in month and open label month
Title
Generalized Anxiety Disorder Score (GAD 7)
Description
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
Time Frame
14 days recall; measured at end of run-in month and blinded month
Title
Generalized Anxiety Disorder Score (GAD 7)
Description
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
Time Frame
14 day recall, recorded at the end of run-in and open label months
Title
Somatic Symptom Severity (Patient Health Questionnaire 15)
Description
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
Time Frame
28 days recall; measured at end of run-in month and blinded month
Title
Somatic Symptom Score (Patient Health Questionnaire-15)
Description
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.
Time Frame
28 day period in run-in month and open label month
Title
Epworth Sleepiness Scale Score
Description
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.
Time Frame
recorded at the end of run-in month and blinded month
Title
Epworth Sleepiness Scale Score
Description
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.
Time Frame
Score recorded at the end of run-in and open label month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen Tietjen, MD
Organizational Affiliation
University of Toledo, HSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo, Health Science Campus
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
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