This trial is active, not recruiting.

Condition migraine
Treatments cranial electrostimulation, sham device
Sponsor University of Toledo Health Science Campus
Start date December 2010
End date February 2013
Trial size 54 participants
Trial identifier NCT01265797, UTHSC-13


Cranial electrotherapy stimulation 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
(Active Comparator)
cranial electrostimulation Fisher Wallace Cranial Electrostimulator
Use cranial electrostimulation device for 20 minutes daily for 28 days
(Sham Comparator)
sham device
Sham Electrostimulator device daily for 20 minutes

Primary Outcomes

Frequency of headache days in diary
time frame: 84 days

Secondary Outcomes

Total duration of headache
time frame: 84 days
Headache Impact Test-6
time frame: Upon enrollment, after experimental phase, completion of open label phase
Migraine Disability Assessment Questionnaire
time frame: Upon enrollment, after experimental period, completion of open label

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Subjects satisfying the IHS 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 CES - Contraindications to Fisher Wallace stimulator, such as cardiac pacemakers or implantable defibrillators, known or suspected heart disease, or pregnancy - Seizure disorders

Additional Information

Official title Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
Principal investigator Gretchen Tietjen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by University of Toledo Health Science Campus.