Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches

University of Toledo Health Science Campus

Status: Completed

Conditions: Migraine

Treatments: Device: Sham Device; Device: Cranial Electrostimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT01265797

UTHSC-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Cranial Electrostimulator

Active Comparator group

Description:

wears active cranial electrostimulation device for 20 minutes daily for 28 days

Treatment:

Device: Cranial Electrostimulator

Sham device

Sham Comparator group

Description:

wears sham device for 20 minutes daily for 28 days

Treatment:

Device: Sham Device