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Non-Invasive Neurostimulation for the Prevention of Chronic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01667250
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
ElectroCore INC

Study Description
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Brief Summary:
The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect preliminary clinical data related to the safety and clinical benefits of daily use of non-invasive vagal nerve stimulation with the GammaCore device for the prevention of chronic migraine, and to support the development and approval of a larger pivotal study.

Condition or disease Intervention/treatment Phase
Chronic Migraine Device: GammaCore Active Device Device: GammaCore Sham Device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Prevention of Chronic Migraine
Study Start Date : October 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: GammaCore Active Device
Subjects will use an Active GammaCore Device
 Device: GammaCore Active Device
Sham Comparator: GammaCore Sham Device
Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
 Device: GammaCore Active Device
Device: GammaCore Sham Device


Outcome Measures
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Primary Outcome Measures :
  1. Safety - Number of Participants With Adverse Events [ Time Frame: Up to 8 weeks - duration of the Randomized period ]
    Safety was assessed by collecting Adverse Effects


Secondary Outcome Measures :
  1. Mean Change in Headache Days [ Time Frame: Run-in period (4 weeks no treatment) and Randomized period (8 weeks) ]
    Mean change in headache days. Change between 4 week run in period to the 8 weeks randomized period.

  2. Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe [ Time Frame: Run-in (4 weeks no treatment) and Randomized (8 weeks) ]
    Peak severity per headache day was reported each headache day in the subject diary. Pain was reported as mild, moderate or severe. Whereas as mild = least severe and severe = most severe.

  3. Use of Pain Relief Medication [ Time Frame: Randomized period - 8 weeks ]
    All abortive headache medication taken during randomized period

  4. Mean Change in Quality of Life Short Form Survey (SF-12) [ Time Frame: Run-in (4 weeks) and Randomized period (8 weeks) ]

    The Quality of Life Short Form Survey (SF-12) is a multipurpose short form survey with 12 questions that are combined, scored and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

    SF-12 were recorded in the subject diary at the Phase 1 follow-up visit (week 4) and during Phase 2 randomized period at week 4 and week 8.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is between the ages of 18 and 65 years.
  • Has been previously diagnosed as suffering from migraine, in accordance with the ICHD-2 Classification criteria (2nd), with or without aura.
  • Experiences at least 15 headache days per month (over the last 3 months).
  • Has age of onset of migraine less than 50 years old.
  • Agrees not to use any migraine prevention treatments (including Botox injections) and/or medications (exclusive of medications taken for acute relief of migraine symptoms).
  • Is able to provide written Informed Consent
  • Agrees to refrain from changing the type or dosage of any prophylactic medications for indications other than chronic migraine that in the opinion of the clinician may interfere with the study

Exclusion Criteria:

  • Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
  • Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore treatment site.
  • Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction.
  • Has an abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction)
  • Has had a previous bilateral, right, or left cervical vagotomy.
  • Has uncontrolled high blood pressure.
  • Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
  • Has a history of carotid endarterectomy or vascular neck surgery on the right side.
  • Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site.
  • Has a recent or repeated history of syncope.
  • Has a recent or repeated history of seizure.
  • Has a known history or suspicion of substance abuse or addiction.
  • Has had a surgery for migraine prevention.
  • Has received Botox injections for migraine prevention within the past 6 months.
  • Has taken medications for migraine prophylaxis in the previous 30 days.
  • In the opinion of the investigator/research staff the subject is incapable of operating the GammaCore device as intended and performing the data collection procedures.
  • Is pregnant, nursing, thinking of becoming pregnant in the next 9 months, or of childbearing years and is unwilling to use an accepted form of birth control.
  • Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
  • Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner).
  • Is a relative of or an employee of the investigator or the clinical study site.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667250


Locations
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United States, California
UCSF Headache Center
San Francisco, California, United States, 94143
United States, Michigan
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Headache Care Center
Springfield, Missouri, United States, 65807
United States, New York
Montefiore Headache Center
Bronx, New York, United States, 10461
United States, North Carolina
Carolina Headache Institute
Chapel Hill, North Carolina, United States, 27516
United States, Pennsylvania
Thomas Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
ElectroCore INC
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ElectroCore INC
ClinicalTrials.gov Identifier: NCT01667250    
Other Study ID Numbers: M-US-02
First Posted: August 17, 2012    Key Record Dates
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018
Last Verified: May 2018
Keywords provided by ElectroCore INC:
vagus nerve stimulation
vagal nerve stimulation
nVNS
VNS
 chronic migraine
migraine
non invasive
gammacore
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases