Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache

2015-03-27 05:53:22 | BioPortfolio


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.


Phase 1: Prospective, randomized (1:1 active treatment:sham control allocation), double blinded, sham controlled treatment (active or sham) phase

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Cluster Headache


GammaCore, Sham GammaCore device


California Medical Clinic for Headache
Santa Monica
United States




ElectroCore LLC

Results (where available)

View Results


Published on BioPortfolio: 2015-03-27T05:53:22-0400

Clinical Trials [1354 Associated Clinical Trials listed on BioPortfolio]

Non-Invasive Vagus Nerve Stimulation (nVNS) With the gammaCore Device for the Acute Treatment of Migraine Attacks

This study is a prospective, multi-centre, randomised, double-blind, sham-controlled investigation designed for comparison of two parallel treatment groups: gammaCore (active nVNS treatmen...

Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines

The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.

A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G

A randomized, sham-controlled, single-centre pilot investigation designed to compare two parallel groups, gammaCore®-G (active treatment) and a sham, (inactive) treatment in subjects with...

Non-invasive TRanscutaneous Cervical Vagus Nerve Stimulation as a Treatment for Acute Stroke; Safety and Feasibility Study

This study aims to determine safety and feasibility of non-invasive transcutaneous cervical Vagus nerve stimulation (nVNS) when delivered promptly after clinical diagnosis of acute stroke....

The Usage of Gammacore in Patients With Disorders of Consciousness

Using Gammacore to treat people with disorders of consciousness (DOC), looking for new ways to treat DOC

PubMed Articles [4449 Associated PubMed Articles listed on BioPortfolio]

Zonisamide for Cluster Headache Prophylaxis: A Case Series.

There is very little literature surrounding the prophylactic use of zonisamide in cluster headaches. The study aims to evaluate the effectiveness of zonisamide for prophylaxis of cluster headache in p...

Chronobiology and Sleep in Cluster Headache.

Cluster headache attacks follow a striking circadian rhythm with an intriguing influence of sleep. We aim to investigate differences in sleep quality, chronotype, and the ability to alter individual s...

Trial of Galcanezumab in Prevention of Episodic Cluster Headache.

Episodic cluster headache is a disabling neurologic disorder that is characterized by daily headache attacks that occur over periods of weeks or months. Galcanezumab, a humanized monoclonal antibody t...

Emerging treatments for cluster headache: hopes and disappointments.

Cluster headache stands among the worst debilitating pain conditions. Available treatments for cluster headache have often disabling side effects, are not tolerated, or are ineffective. The management...

Behavioral and psychological aspects of cluster headache: an overview.

This paper overviews available literature addressing behavioral and psychological aspects of cluster headache. Behavioral correlates of sleep and drug use are explored, as are the psychological correl...

Medical and Biotech [MESH] Definitions

A primary headache disorder that is characterized by severe, strictly unilateral PAIN which is orbital, supraorbital, temporal or in any combination of these sites, lasting 15-180 min. occurring 1 to 8 times a day. The attacks are associated with one or more of the following, all of which are ipsilateral: conjunctival injection, lacrimation, nasal congestion, rhinorrhea, facial SWEATING, eyelid EDEMA, and miosis. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

A primary headache disorder that is similar to the CLUSTER HEADACHE with unilateral head pain, but differs by its multiple short severe attacks. It is usually seen in females, and may be responsive to non-steroidal-anti-inflammatory drugs (NSAIDS).

Various conditions with the symptom of HEADACHE. Headache disorders are classified into major groups, such as PRIMARY HEADACHE DISORDERS (based on characteristics of their headache symptoms) and SECONDARY HEADACHE DISORDERS (based on their etiologies). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.

Conditions in which the primary symptom is HEADACHE and the headache cannot be attributed to any known causes.

More From BioPortfolio on "Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache"

Quick Search

Relevant Topic

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...

Searches Linking to this Trial