Clinical trial NCT01265797: Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
Official title: Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Headache Days
timeFrame: 28 day period during run-in month and blinded month
measure: Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9)
timeFrame: 14 days recall; measured at end of run-in month and blinded month
Secondary outcomes:
measure: Headache Days
timeFrame: 28 day period in run-in month and open label month
measure: Depression Score (Patient Health Questionnaire-9)
timeFrame: 14 day recall, recorded at the end of run-in and open label months
measure: Headache Impact Test-6
timeFrame: after run-in month, after blinded month
measure: Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches)
timeFrame: 28 day period in run-in month and open label month
measure: Generalized Anxiety Disorder Score (GAD 7)
timeFrame: 14 days recall; measured at end of run-in month and blinded month
measure: Generalized Anxiety Disorder Score (GAD 7)
timeFrame: 14 day recall, recorded at the end of run-in and open label months
measure: Somatic Symptom Severity (Patient Health Questionnaire 15)
timeFrame: 28 days recall; measured at end of run-in month and blinded month
measure: Somatic Symptom Score (Patient Health Questionnaire-15)
timeFrame: 28 day period in run-in month and open label month
measure: Epworth Sleepiness Scale Score
timeFrame: recorded at the end of run-in month and blinded month
measure: Epworth Sleepiness Scale Score
timeFrame: Score recorded at the end of run-in and open label month
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo, Health Science Campus
state: Ohio
Study officials:
affiliation: University of Toledo, HSC
name: Gretchen Tietjen, MD
role: PRINCIPAL_INVESTIGATOR
References: