Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine

NCT ID: NCT01532830

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-07-25

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.

Conditions

Migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active

n-VNS active therapy

Group Type: EXPERIMENTAL

n-VNS

Intervention Type: DEVICE

Interventions

n-VNS

Intervention Type: DEVICE

Other Intervention Names

gammaCore

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ElectroCore INC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCSF Headache Center

San Francisco, California, United States

New York Headache Center

New York, New York, United States

Montefiore Headache Center

The Bronx, New York, United States

Countries

United States

References

Goadsby PJ, Grosberg BM, Mauskop A, Cady R, Simmons KA. Effect of noninvasive vagus nerve stimulation on acute migraine: an open-label pilot study. Cephalalgia. 2014 Oct;34(12):986-93. doi: 10.1177/0333102414524494. Epub 2014 Mar 7.

Reference Type: RESULT

PMID: 24607501 (View on PubMed)

Other Identifiers

M-US-01

Identifier Type: -

Identifier Source: org_study_id