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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
  Purpose

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.


Condition Intervention
Migraine
 Device: Cranial electrostimulation
Device: Sham Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by University of Toledo Health Science Campus:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 54
Study Start Date: December 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Treatment Device: Cranial electrostimulation
Use cranial electrostimulation device for 20 minutes daily for 28 days
Other Name: Fisher Wallace Cranial Electrostimulator
Sham Comparator: Control Device: Sham Device
Sham Electrostimulator device daily for 20 minutes

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265797

Locations
United States, Ohio
University of Toledo, Health Science Campus
Toledo, Ohio, United States, 43614
Sponsors and Collaborators
University of Toledo Health Science Campus
Investigators
Principal Investigator: Gretchen Tietjen, MD University of Toledo, HSC
  More Information

No publications provided

Responsible Party: Gretchen Tietjen, MD, Principal Investigator, University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT01265797     History of Changes
Other Study ID Numbers: UTHSC-13
Study First Received: December 15, 2010
Last Updated: January 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013