Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine
1 other identifier
interventional
30
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2012
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 10, 2012
CompletedFirst Posted
Study publicly available on registry
February 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2012
CompletedResults Posted
Study results publicly available
May 11, 2018
CompletedJuly 10, 2018
June 1, 2018
5 months
February 10, 2012
March 7, 2018
June 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety - Number of Participants With Adverse Effects
The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.
End of Study - 7 weeks
Secondary Outcomes (5)
Mean Change in Headache Pain From Baseline to 120 Minutes
120 minutes
Change in Photophobia (Visual) From Baseline to 120 Minutes
Base line and 120 minutes
Change in Phonophobia (Auditory) From Baseline to 120 Minutes
Baseline and 120 minutes
Mean Change in Nausea From Baseline to 120 Minutes
Baseline 120 minutes
Mean Change in Functional Disability
Baseline and 120 minutes
Study Arms (1)
Active
EXPERIMENTALn-VNS active therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ElectroCore INClead
Study Sites (3)
UCSF Headache Center
San Francisco, California, 94143, United States
New York Headache Center
New York, New York, 10021, United States
Montefiore Headache Center
The Bronx, New York, 10461, United States
Related Publications (1)
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.
PMID: 24607501RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Affairs
- Organization
- electroCore LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2012
First Posted
February 15, 2012
Study Start
February 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 25, 2012
Last Updated
July 10, 2018
Results First Posted
May 11, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share