Clinical trial NCT01532830: Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine
Official title: Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device For the Relief of Symptoms Associated With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: vagus nerve stimulation
vagal nerve stimulation
nVNS
VNS
migraine
non invasive
gammacore
Lead sponsor: ElectroCore INC
Sponsor class: INDUSTRY
First posted: 2012-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety - Number of Participants With Adverse Effects
timeFrame: End of Study - 7 weeks
Secondary outcomes:
measure: Mean Change in Headache Pain From Baseline to 120 Minutes
timeFrame: 120 minutes
measure: Change in Photophobia (Visual) From Baseline to 120 Minutes
timeFrame: Base line and 120 minutes
measure: Change in Phonophobia (Auditory) From Baseline to 120 Minutes
timeFrame: Baseline and 120 minutes
measure: Mean Change in Nausea From Baseline to 120 Minutes
timeFrame: Baseline 120 minutes
measure: Mean Change in Functional Disability
timeFrame: Baseline and 120 minutes
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Headache Center
state: California
city: Bronx
country: United States
facility: Montefiore Headache Center
state: New York
city: New York
country: United States
facility: New York Headache Center
state: New York
Study officials:
References:
citation: 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.