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Non-Invasive Neurostimulation For the Relief of Symptoms Associated With 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: NCT01532830
Recruitment Status : Completed
First Posted : February 15, 2012
Results First Posted : May 11, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
ElectroCore INC

Study Description
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Brief Summary:
The purpose of this pilot study is to assess feasibility and clarify the design of future study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or prevention of migraine symptoms.

Condition or disease Intervention/treatment Phase
Migraine Device: n-VNS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device For the Relief of Symptoms Associated With Migraine
Actual Study Start Date : February 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 25, 2012

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
Experimental: Active
n-VNS active therapy
 Device: n-VNS
Other Name: gammaCore


Outcome Measures
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Primary Outcome Measures :
  1. Safety - Number of Participants With Adverse Effects [ Time Frame: End of Study - 7 weeks ]
    The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.


Secondary Outcome Measures :
  1. Mean Change in Headache Pain From Baseline to 120 Minutes [ Time Frame: 120 minutes ]

    Headache was measured on a 4 point scale where 0 = no pain, 1 = mild, 2 = moderate, 3 = severe pain at baseline (start of attack), 5, 15, 30, 45, 60, 90 and 120 minutes.

    Data presented shows the average change from baseline to 120 minutes


  2. Change in Photophobia (Visual) From Baseline to 120 Minutes [ Time Frame: Base line and 120 minutes ]
    Presence of photophobia (yes or no) was captured at baseline and 120 minutes.

  3. Change in Phonophobia (Auditory) From Baseline to 120 Minutes [ Time Frame: Baseline and 120 minutes ]
    Presence of phonophobia (yes or no) was captured at baseline and 120 minutes.

  4. Mean Change in Nausea From Baseline to 120 Minutes [ Time Frame: Baseline 120 minutes ]
    Nausea was captured in the diary and measured on a 4 point scale, where 0 = no nausea, 1 = mild, 2 = moderate and 3 = severe nausea, at baseline and 120 minutes.

  5. Mean Change in Functional Disability [ Time Frame: Baseline and 120 minutes ]
    Functional disability was captured in the diary and measured on a 4 point scale, where 0 = no disability, able to function normally and where 3 = performance of daily activities severely impaired, measured at baseline and 120 minutes.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is between the ages of 18 and 55 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 2 migraines per month, but less than 15 headache days per month (over the last 3 months).
  • Has age of onset of migraine less than 50 years old.
  • Is able to give written Informed Consent

Exclusion Criteria:

  • Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
  • Has a lesion (including lymphadenopathy) 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), coronary artery disease or recent myocardial infarction.
  • Has a history or baseline ECG that identifies the presence of a clinically significant unstable cardiac arrhythmia, second degree heart block type II, history of ventricular tachycardia or ventricular fibrillation, or known cardiac syndromes that may be associated with increased risk of sudden death in otherwise healthy people.
  • Has had a previous bilateral or right cervical vagotomy.
  • Has a clinically significant irregular heart rate or rhythm.
  • Has uncontrolled high blood pressure.
  • Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, 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 history or suspicion of narcotic abuse.
  • Takes medication for acute headaches more than 10 days per month.
  • Is pregnant, nursing, thinking of becoming pregnant in the next 3 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): NCT01532830


Locations
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United States, California
UCSF Headache Center
San Francisco, California, United States, 94143
United States, New York
Montefiore Headache Center
Bronx, New York, United States, 10461
New York Headache Center
New York, New York, United States, 10021
Sponsors and Collaborators
ElectroCore INC
More Information
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Publications of Results:

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Responsible Party: ElectroCore INC
ClinicalTrials.gov Identifier: NCT01532830    
Other Study ID Numbers: M-US-01
First Posted: February 15, 2012    Key Record Dates
Results First Posted: May 11, 2018
Last Update Posted: July 10, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ElectroCore INC:
vagus nerve stimulation
vagal nerve stimulation
nVNS
VNS
 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