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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cranial Electrostimulator | Active Comparator | wears active cranial electrostimulation device for 20 minutes daily for 28 days |
|
| Sham device | Sham Comparator | wears sham device for 20 minutes daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranial Electrostimulator | Device | participant wears active cranial electrostimulation device for 20 minutes daily for 28 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen Tietjen, MD | University of Toledo, HSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toledo, Health Science Campus | Toledo | Ohio | 43614 | United States |
Enrolled participants were randomized to receive verum or sham intervention. Completion of one (run-in) month headache diary was required before obtaining device.
Recruitment dates: Dec 2010 - Jan 2013 Recruitment status: Not enrolling. Location: Neurology Clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Verum | Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days |
| FG001 | Sham | Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-in Month |
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| Blinded Month |
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| Open Label Month |
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The overall number of baseline participants used for analysis is the number completing the blinded period from the run-in period, and differs from the number of participants started in the Participant Flow Module due to drop-out and other causes listed in the participant flow module.
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| ID | Title | Description |
|---|---|---|
| BG000 | Verum | Verum : wears active Electrostimulator device daily for 20 minutes for 28 days |
| BG001 | Sham | Sham Device : wears Sham device daily for 20 minutes for 28 days |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | 95% Confidence Interval | headache days/ 28 day period | 28 day period during run-in month and blinded month |
|
Over the 28 day blinded period, and 28 day open label period for those wishing to continue after completion of the study (total of 8 weeks)
Inquiry regarding adverse events was made at the visits following the blinded and open label period. We also recorded adverse events reported during phone calls with participants during the blinded and open label period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Verum | Verum : wears active cranial electrostimulation (CES) device for 20 minutes daily for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual Flickering | Eye disorders | Non-systematic Assessment | Sensation of visual flickering related to electrical pulse, was irritating and possibly worsened headache while wearing |
Recall bias in completing survey instruments. Incomplete diary data with regards to headache symptoms, acute medication use and relief limited analysis for other proposed secondary outcomes.Higher than anticipated drop-out rate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gretchen Tietjen, MD | University of Toledo | 419-383-3544 | gretchen.tietjen@utoledo.edu |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Sham Device | Device | participant wears sham device for 20 minutes daily for 28 days |
|
| 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 |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | 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). | Posted | Mean | 95% Confidence Interval | headache days/ 28 day period | 28 day period in run-in month and open label month |
|
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|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 14 day recall, recorded at the end of run-in and open label months |
|
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|
|
| Primary | 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. | The number of participants included the individuals who have completed the run-in period and the blinded period. The data was analyzed 'per protocol' based on the number of participants completing the blinded period. | Posted | Mean | 95% Confidence Interval | depression score/14 day recall | 14 days recall; measured at end of run-in month and blinded month |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | after run-in month, after blinded month |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 28 day period in run-in month and open label month |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | 14 days recall; measured at end of run-in month and blinded month |
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|
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | 14 day recall, recorded at the end of run-in and open label months |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | 28 days recall; measured at end of run-in month and blinded month |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 28 day period in run-in month and open label month |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | recorded at the end of run-in month and blinded month |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Score recorded at the end of run-in and open label month |
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| 0 |
| 34 |
| 6 |
| 34 |
| EG001 | Sham | Sham: wears sham cranial electrostimulation (CES) device for 20 minutes daily for 28 days | 0 | 34 | 0 | 34 |
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| D009422 | Nervous System Diseases |