Non-Invasive Neurostimulation of the Vagus Nerve with the GammaCore device for the treatment of cluster headaches
The study is designed to collect clinical data related to the safety and effectiveness of non invasive vagus nerve stimulation with the GammaCore device in the treatment of Cluster Headaches. Double-blinded subjects will use the device, either active or sham, for a given number of headache events, at which point they will be placed in the active device, unblinded group for a described number of headache events. Subjects will be randomized by sponsor designee. Subjects will keep a headache diary describing their symptoms prior to using the device, and post use of device. These will be reviewed and collected through out the study.outcome variables are headaches will diminish, stop,or continue. Subjects are permitted to take their usual headaches relief medications after a given period post treatment with GammaCore device, so sham arm subects will experience their headache 15 minutes longer, before taking their usual alternative treatments. Study endpoints will be : Decribed number of headache events have been treated, and study period ends, or adverse reaction to treatment with device, will stop usage of device.
1. Is between the ages of 18 and 75 years.
2. Has been diagnosed with episodic cluster headache, in accordance with the
ICHD-2 Classification criteria (2ndEd), or Chronic Cluster headache patients.
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. Is currently experiencing cluster headaches, and from clinical history is expected
to continue experiencing cluster headaches for a period of at least 4 weeks.
4. Is able to distinguish CH from other headaches (i.e. migraine, tension-type
5. Is capable of completing headache pain self-assessments.
ElectroCore(RegisteredTM) LLC, Confidential Pivotal Study Protocol CH-US-01
November 14, 2012 page 18 of 50
6. Agrees to use the GammaCore device as intended and follow all of the
requirements of the study, including follow-up visit requirements.
7. 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.
8. Is able to provide written Informed Consent.