Non-Invasive Neurostimulation for the Prevention of Chronic Migraine

May 22, 2018 updated by: ElectroCore INC

Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Prevention of Chronic Migraine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Headache Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain & Neurological Institute
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Headache Care Center
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Headache Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • Carolina Headache Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 8 weeks - duration of the Randomized period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Run-in period (4 weeks no treatment) and Randomized period (8 weeks)
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.
Run-in (4 weeks no treatment) and Randomized (8 weeks)
Use of Pain Relief Medication
Time Frame: Randomized period - 8 weeks
All abortive headache medication taken during randomized period
Randomized period - 8 weeks
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.
Run-in (4 weeks) and Randomized period (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ElectroCore INC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

August 15, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-US-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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