Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Gretchen Tietjen, MD, University of Toledo Health Science Campus

ClinicalTrials.gov Identifier:

NCT01265797

First received: December 15, 2010

Last updated: January 21, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 15, 2010

Last Updated Date

January 21, 2013

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency of headache days in diary [ Time Frame: 84 days ] [ Designated as safety issue: No ]

A good response is >= 50% reduction in headache day frequency and is congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache.

Original Primary Outcome Measures ^ICMJE

Frequency of headache days in diary [ Time Frame: 84 days ] [ Designated as safety issue: No ]

A good response is >= 50% reduction in heachae day requency and is congruent with teh Guidelines for Trial of Behavioral Treatments for Recurrent Headache.

Change History

Complete list of historical versions of study NCT01265797 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Total duration of headache [ Time Frame: 84 days ] [ Designated as safety issue: No ]
Headache Impact Test-6 [ Time Frame: Upon enrollment, after experimental phase, completion of open label phase ] [ Designated as safety issue: No ]
Migraine Disability Assessment Questionnaire [ Time Frame: Upon enrollment, after experimental period, completion of open label ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Total duration of headache [ Time Frame: 84 days ] [ Designated as safety issue: No ]
Headache Impact Test-6 [ Time Frame: Upon enrollment, after experimental phase, completion of open lable phase ] [ Designated as safety issue: No ]
Migraine Disability Assessment Questionnaire [ Time Frame: Upon enrollment, after experimental period, completion of open lable ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches

Official Title ^ICMJE

Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Migraine

Intervention ^ICMJE

Device: Cranial electrostimulation
Use cranial electrostimulation device for 20 minutes daily for 28 days

Other Name: Fisher Wallace Cranial Electrostimulator
Device: Sham Device
Sham Electrostimulator device daily for 20 minutes

Study Arm (s)

Active Comparator: Active Treatment
Intervention: Device: Cranial electrostimulation
Sham Comparator: Control
Intervention: Device: Sham Device

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01265797

Other Study ID Numbers ^ICMJE

UTHSC-13

Has Data Monitoring Committee

Responsible Party

Gretchen Tietjen, MD, University of Toledo Health Science Campus

Study Sponsor ^ICMJE

University of Toledo Health Science Campus

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gretchen Tietjen, MD

University of Toledo, HSC

Information Provided By

University of Toledo Health Science Campus

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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