Non-Invasive Neurostimulation for the Prevention of Chronic Migraine
1 other identifier
interventional
59
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2012
6 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
First Submitted
Initial submission to the registry
August 15, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
June 20, 2018
CompletedJune 20, 2018
May 1, 2018
1.6 years
August 15, 2012
March 8, 2018
May 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety - Number of Participants With Adverse Events
Safety was assessed by collecting Adverse Effects
Up to 8 weeks - duration of the Randomized period
Secondary Outcomes (4)
Mean Change in Headache Days
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
Run-in (4 weeks no treatment) and Randomized (8 weeks)
Use of Pain Relief Medication
Randomized period - 8 weeks
Mean Change in Quality of Life Short Form Survey (SF-12)
Run-in (4 weeks) and Randomized period (8 weeks)
Study Arms (2)
GammaCore Active Device
ACTIVE COMPARATORSubjects will use an Active GammaCore Device
GammaCore Sham Device
SHAM COMPARATORSubjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ElectroCore INClead
Study Sites (6)
UCSF Headache Center
San Francisco, California, 94143, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Headache Care Center
Springfield, Missouri, 65807, United States
Montefiore Headache Center
The Bronx, New York, 10461, United States
Carolina Headache Institute
Chapel Hill, North Carolina, 27516, United States
Thomas Jefferson Headache Center
Philadelphia, Pennsylvania, 19107, United States
Related Publications (1)
Silberstein SD, Calhoun AH, Lipton RB, Grosberg BM, Cady RK, Dorlas S, Simmons KA, Mullin C, Liebler EJ, Goadsby PJ, Saper JR; EVENT Study Group. Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study. Neurology. 2016 Aug 2;87(5):529-38. doi: 10.1212/WNL.0000000000002918. Epub 2016 Jul 13.
PMID: 27412146DERIVED
Related Links
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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2012
First Posted
August 17, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 20, 2018
Results First Posted
June 20, 2018
Record last verified: 2018-05