Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache
NCT ID: NCT01792817
Last Updated: 2019-12-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2013-02-28
2014-10-31
Brief Summary
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Detailed Description
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Phase 2: Prospective, non-randomized, active treatment phase.
Phase 1 - Two Arms:
1. Active Treatment with the GammaCore Device
2. Sham Treatment with a placebo device
Phase 2 - One Arm:
Active Treatment with the GammaCore Device
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Sham GammaCore device
The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
Sham GammaCore device
Treatment with sham stimulator
GammaCore Device
Non-Invasive Vagus Nerve Stimulator
GammaCore
Treatment with active gammacore vagus nerve stimulator
Interventions
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GammaCore
Treatment with active gammacore vagus nerve stimulator
Sham GammaCore device
Treatment with sham stimulator
Eligibility Criteria
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Inclusion Criteria
2. 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
3. currently experiencing cluster headaches, and from clinical history is expected to continue experiencing cluster headaches for a period of at least 4 weeks.
4. able to distinguish CH from other headaches (i.e. migraine, tension-type headaches).
5. capable of completing headache pain self-assessments.
6. \[Intentionally left blank\].
7. Agrees to use the GammaCore device as intended and follow all of the requirements of the study, including follow-up visit requirements.
8. Agrees to record usage of the GammaCore device, all required study data, and report any adverse device effects to the study center within 24 hours of any such adverse device effects.
9. able to provide written Informed Consent
Exclusion Criteria
2. 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.
3. \[Intentionally left blank\].
4. 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.
5. history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
6. lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the treatment site.
7. structural intracranial, or cervical vascular lesions that may potentially cause headache attacks.
8. other significant pain problem (including cancer pain, fibromyalgia, and trigeminal neuralgia/TAC-cluster) that might confound the study assessments.
9. 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.
10. history of prolonged QT interval or a history of clinically significant arrhythmia.
11. 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).
12. previous bilateral or right cervical vagotomy.
13. uncontrolled high blood pressure.
14. 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.
15. history of carotid endarterectomy or vascular neck surgery on the right side.
16. implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site.
17. recent or repeated history of syncope.
18. recent or repeated history of seizure.
19. known history or suspicion of substance abuse or addiction, or overuse of acute headache medication for headaches other than CH.
20. psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the clinician may interfere with the study.
21. pregnant, nursing, thinking of becoming pregnant in the next 4 months, or of childbearing years and is unwilling to use an accepted form of birth control.
22. participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
23. 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
18 Years
75 Years
ALL
No
Sponsors
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ElectroCore INC
INDUSTRY
Responsible Party
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Principal Investigators
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Lia Spitzer
Role: STUDY_DIRECTOR
ElectroCore INC
Locations
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California Medical Clinic for Headache
Santa Monica, California, United States
Stanford University Medical Center
Stanford, California, United States
Colorado Neurological Institute
Englewood, Colorado, United States
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, United States
Tampa General Hospital Headache Center
Tampa, Florida, United States
Diamond Headache Clinic
Chicago, Illinois, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Norton Neurology
Louisville, Kentucky, United States
Mid-Atlantic Headache Institute
Pikesville, Maryland, United States
New England Regional Headache Center
Worcester, Massachusetts, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
Headache Care Center
Springfield, Missouri, United States
Dent Neurologic Institute
Amherst, New York, United States
Montefiore Headache Center
New York, New York, United States
Center for Headache Care and Research at Island Neurological Associates, PC
Plainview, New York, United States
Carolina Headache Institute
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Jefferson Headache Center
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
West Virginia University Dept of Neurology
Morgantown, West Virginia, United States
Countries
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References
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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.
Silberstein 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.
Other Identifiers
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CH-US-01
Identifier Type: -
Identifier Source: org_study_id