Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches

NCT ID: NCT01265797

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-07-31

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cranial Electrostimulator

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

Group Type: ACTIVE_COMPARATOR

Cranial Electrostimulator

Intervention Type: DEVICE

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

Sham device

wears sham device for 20 minutes daily for 28 days

Group Type: SHAM_COMPARATOR

Sham Device

Intervention Type: DEVICE

participant wears sham device for 20 minutes daily for 28 days

Interventions

Cranial Electrostimulator

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

Intervention Type: DEVICE

Sham Device

participant wears sham device for 20 minutes daily for 28 days

Intervention Type: DEVICE

Other Intervention Names

Fisher Wallace Cranial Electrostimulator

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Toledo Health Science Campus

OTHER

Sponsor Role: lead

Responsible Party

Gretchen Tietjen, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gretchen Tietjen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toledo, HSC

Locations

University of Toledo, Health Science Campus

Toledo, Ohio, United States

Countries

United States

Other Identifiers

UTHSC-13

Identifier Type: -

Identifier Source: org_study_id