Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches

NCT01265797 | Completed Results

• 1 other identifier: UTHSC-13
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• Mean Headache Days

  Mean change in headache days between 28 day run-in month and 28 day blinded month, i.e. run-in month mean minus blinded month mean. A good response is \>= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).

  28 day period during run-in month and blinded month

• Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9)

  Mean difference of PHQ-9 score between the run-in month and blinded month, i.e. PHQ-9 score from run-in month minus blinded month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.

  14 days recall; measured at end of run-in month and blinded month

Secondary Outcomes (10)

• Headache Days

  28 day period in run-in month and open label month

• Depression Score (Patient Health Questionnaire-9)

  14 day recall, recorded at the end of run-in and open label months

• Headache Impact Test-6

  after run-in month, after blinded month

• Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches)

  28 day period in run-in month and open label month

• Generalized Anxiety Disorder Score (GAD 7)

  14 days recall; measured at end of run-in month and blinded month

Study Arms (2)

Cranial Electrostimulator

ACTIVE COMPARATOR

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

Device: Cranial Electrostimulator

Sham device

SHAM COMPARATOR

wears sham device for 20 minutes daily for 28 days

Device: Sham Device

Interventions

Cranial Electrostimulator DEVICE

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

Also known as: Fisher Wallace Cranial Electrostimulator

Cranial Electrostimulator

Sham Device DEVICE

participant wears sham device for 20 minutes daily for 28 days

Sham device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead

Study Sites (1)

University of Toledo, Health Science Campus

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

Recall bias in completing survey instruments. Incomplete diary data with regards to headache symptoms, acute medication use and relief limited analysis for other proposed secondary outcomes.Higher than anticipated drop-out rate.

Results Point of Contact

• Title: Gretchen Tietjen, MD
• Organization: University of Toledo

gretchen.tietjen@utoledo.edu

419-383-3544

Study Officials

• Gretchen Tietjen, MD

  University of Toledo, HSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 23, 2010
• Study Start: December 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 10, 2015
• Results First Posted: February 10, 2015

Record last verified: 2015-02

Locations

US (1)