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Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache
NCT01792817 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE GammaCore
- DEVICE Sham GammaCore device
Study Locations (20)
New York
- Dent Neurologic Institute — Amherst
- Montefiore Headache Center — New York
- Center for Headache Care and Research at Island Neurological Associates, PC — Plainview
California
- California Medical Clinic for Headache — Santa Monica
- Stanford University Medical Center — Stanford
Colorado
- Colorado Neurological Institute — Englewood
Connecticut
- Associated Neurologists of Southern Connecticut — Fairfield
Florida
- Tampa General Hospital Headache Center — Tampa
Illinois
- Diamond Headache Clinic — Chicago
Iowa
- University of Iowa Hospital and Clinics — Iowa City
Kentucky
- Norton Neurology — Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01792817
The ClinicalTrials.gov registry entry for NCT01792817 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ElectroCore, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cluster Headache appearing as the primary indexed condition, and to 2 interventions — of which GammaCore is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01792817 reports 20 study locations spanning 17 distinct geographic areas — top geographies include New York, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01792817 about?
NCT01792817 is a clinical study titled "Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache". 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 treatme...
What is the current status of trial NCT01792817?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2013-02. Estimated completion is 2014-10.
What conditions does trial NCT01792817 study?
This clinical trial studies the following conditions: Cluster Headache. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01792817?
The interventions under investigation include: GammaCore (DEVICE), Sham GammaCore device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01792817?
This trial is sponsored by ElectroCore, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01792817 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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