Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache
CH
1 other identifier
interventional
150
1 country
20
Brief Summary
Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of cluster headache. The study compares the safety and effectiveness of an active treatment (GammaCore) against a sham treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 8, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
May 17, 2018
CompletedDecember 17, 2019
December 1, 2019
1.3 years
February 8, 2013
November 24, 2016
December 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Repsonse to Treatment
The primary outcome measurement for effectiveness is the rate of responders for the active treatment group, compared to the sham control group. A responder is defined as a subject who has recorded an intensity of 0 or 1 on the 5-point headache pain scale (no pain, mild, moderate, severe, very severe) at 15 minutes post-initiation of treatment of the first treated cluster headache attack of Phase 1.
15 minutes post stimulation
Secondary Outcomes (3)
Sustained Treatment Success at 1 Hour Post-Treatment
For 1 hour post stimulation
Average Mean Attack Intensities Experienced Per Subject
15 minutes post-stimulation
Incidence and Occurrence of Serious Adverse Events Related to Active or Sham Study Treatment and / or to Cluster Headache Events.
4 weeks, Phase 1
Study Arms (2)
Sham GammaCore device
SHAM COMPARATORThe Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
GammaCore Device
EXPERIMENTALNon-Invasive Vagus Nerve Stimulator
Interventions
Eligibility Criteria
You may qualify if:
- Is between the ages of 18 and 75 years.
- Has been diagnosed with cluster headache, in accordance with the ICHD-2
- Classification criteria (2ndEd):
- o At least 5 attacks fulfilling the following criteria:
- Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated
- Headache is accompanied by at least 1 of the following:
- Ipsilateral conjunctival injection and/or lacrimation
- Ipsilateral nasal congestion and/or rhinorrhea
- Ipsilateral eyelid edema
- Ipsilateral forehead and facial sweating
- Ipsilateral miosis and/or ptosis
- A sense of restlessness or agitation
- currently experiencing cluster headaches, and from clinical history is expected to continue experiencing cluster headaches for a period of at least 4 weeks.
- able to distinguish CH from other headaches (i.e. migraine, tension-type headaches).
- capable of completing headache pain self-assessments.
- +4 more criteria
You may not qualify if:
- had surgery to treat cluster headache.
- currently taking prophylactic medication (including chronic opioids and non-prescribed street drugs) for indications other than CH that in the opinion of the clinician may interfere with the study.
- \[Intentionally left blank\].
- undergone botulinum toxin injections in the head and/or neck in the last 3 months or nerve blocks (occipital or other) in the head or neck in the last month.
- history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
- lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the treatment site.
- structural intracranial, or cervical vascular lesions that may potentially cause headache attacks.
- other significant pain problem (including cancer pain, fibromyalgia, and trigeminal neuralgia/TAC-cluster) that might confound the study assessments.
- 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.
- history of prolonged QT interval or a history of clinically significant arrhythmia.
- 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).
- previous bilateral or right cervical vagotomy.
- uncontrolled high blood pressure.
- 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.
- history of carotid endarterectomy or vascular neck surgery on the right side.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ElectroCore INClead
Study Sites (20)
California Medical Clinic for Headache
Santa Monica, California, 90404, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, 06824, United States
Tampa General Hospital Headache Center
Tampa, Florida, 33606, United States
Diamond Headache Clinic
Chicago, Illinois, 60642, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242, United States
Norton Neurology
Louisville, Kentucky, 40207, United States
Mid-Atlantic Headache Institute
Pikesville, Maryland, 21208, United States
New England Regional Headache Center
Worcester, Massachusetts, 01605, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Headache Care Center
Springfield, Missouri, 65807, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
Montefiore Headache Center
New York, New York, 10461, United States
Center for Headache Care and Research at Island Neurological Associates, PC
Plainview, New York, 11803, United States
Carolina Headache Institute
Chapel Hill, North Carolina, 27516, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
West Virginia University Dept of Neurology
Morgantown, West Virginia, 26506, United States
Related Publications (2)
de Coo IF, Marin JC, Silberstein SD, Friedman DI, Gaul C, McClure CK, Tyagi A, Liebler E, Tepper SJ, Ferrari MD, Goadsby PJ. Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis. Cephalalgia. 2019 Jul;39(8):967-977. doi: 10.1177/0333102419856607. Epub 2019 Jun 10.
PMID: 31246132DERIVEDSilberstein SD, Mechtler LL, Kudrow DB, Calhoun AH, McClure C, Saper JR, Liebler EJ, Rubenstein Engel E, Tepper SJ; ACT1 Study Group. Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study. Headache. 2016 Sep;56(8):1317-32. doi: 10.1111/head.12896.
PMID: 27593728DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Affairs
- Organization
- electroCore, LLC
Study Officials
- STUDY DIRECTOR
Lia Spitzer
ElectroCore INC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2013
First Posted
February 15, 2013
Study Start
February 1, 2013
Primary Completion
June 1, 2014
Study Completion
October 1, 2014
Last Updated
December 17, 2019
Results First Posted
May 17, 2018
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share