Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches

This study has been completed.
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: February 2, 2015
Last verified: February 2015
  Purpose
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.

Condition Intervention
Migraine
Device: Cranial Electrostimulator
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:


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

Primary Outcome Measures:
  • Mean Headache Days [ Time Frame: 28 day period during run-in month and blinded month ] [ Designated as safety issue: No ]
    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).

  • Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9) [ Time Frame: 14 days recall; measured at end of run-in month and blinded month ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Headache Days [ Time Frame: 28 day period in run-in month and open label month ] [ Designated as safety issue: No ]
    Mean change in headache days between 28 day run-in month and 28 day open label month, i.e. run-in month mean minus open label month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).

  • Depression Score (Patient Health Questionnaire-9) [ Time Frame: 14 day recall, recorded at the end of run-in and open label months ] [ Designated as safety issue: No ]
    Mean difference of PHQ-9 score between the run-in month and open label month, i.e. PHQ-9 score from run-in month minus open label 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.

  • Headache Impact Test-6 [ Time Frame: after run-in month, after blinded month ] [ Designated as safety issue: No ]
    Mean difference in HIT-6 score between run-in month and blinded month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability.

  • Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches) [ Time Frame: 28 day period in run-in month and open label month ] [ Designated as safety issue: No ]
    Mean difference in HIT-6 score between run-in month and open label month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability.

  • Generalized Anxiety Disorder Score (GAD 7) [ Time Frame: 14 days recall; measured at end of run-in month and blinded month ] [ Designated as safety issue: No ]
    Mean difference in GAD 7 score between run-in month and blinded month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety

  • Generalized Anxiety Disorder Score (GAD 7) [ Time Frame: 14 day recall, recorded at the end of run-in and open label months ] [ Designated as safety issue: No ]
    Mean difference in GAD 7 score between run-in month and open label month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety

  • Somatic Symptom Severity (Patient Health Questionnaire 15) [ Time Frame: 28 days recall; measured at end of run-in month and blinded month ] [ Designated as safety issue: No ]
    Mean difference in PHQ 15 score between run-in month and blinded month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 ("not bothered at all") to 2 ("bothered a lot"). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms

  • Somatic Symptom Score (Patient Health Questionnaire-15) [ Time Frame: 28 day period in run-in month and open label month ] [ Designated as safety issue: No ]
    Mean difference in PHQ 15 score between run-in month and open label month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 ("not bothered at all") to 2 ("bothered a lot"). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms.

  • Epworth Sleepiness Scale Score [ Time Frame: recorded at the end of run-in month and blinded month ] [ Designated as safety issue: No ]
    Mean difference of Epworth Sleepiness Scale score between run-in month and blinded month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in "recent times". The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep.

  • Epworth Sleepiness Scale Score [ Time Frame: Score recorded at the end of run-in and open label month ] [ Designated as safety issue: No ]
    Mean difference of Epworth Sleepiness Scale score between run-in month and open label month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in "recent times". The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep.


Enrollment: 68
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cranial Electrostimulator
wears active cranial electrostimulation device for 20 minutes daily for 28 days
Device: Cranial Electrostimulator
participant wears active cranial electrostimulation device for 20 minutes daily for 28 days
Other Name: Fisher Wallace Cranial Electrostimulator
Sham Comparator: Sham device
wears sham device for 20 minutes daily for 28 days
Device: Sham Device
participant wears sham device for 20 minutes daily for 28 days

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   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: August 7, 2013
Last Updated: February 2, 2015
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 August 22, 2016