The study will look at a non-invasive treatment for people suffering with chronic and episodic headaches. Study subjects will be randomized to an active treatment or an in-active treatment for 2 weeks. After the 2 weeks all subjects will continue to treat with an active treatment for an additional 2 weeks.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Is 18 years or older
* Has been diagnosed with episodic or chronic cluster headache in accordance with the ICHD-2 Classification criteria (2ndEd)
* Is capable of completing the 5-point pain scale, disability scale and other self-assessments
* Agrees to refrain from starting new medication aimed to control the cluster headache for the duration of the run-in and randomized phase
* Is able to provide written Informed Consent
Exclusion Criteria:1.
* Episodic cluster headache sufferers who are not in a cluster headache bout at the time of screening and enrollment
* 2\. Need to commence treatment with oral or injectable steroids for eventual concomitant medical conditions
* 3\. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore® treatment site
* 4\. Is currently taking medication for indications other than CH that in the opinion of the clinician may interfere with the study
* 5\. Has a history of any cranial aneurysm, intracranial haemorrhage, brain tumours or significant head trauma
* 6\. Diagnosed or suspected secondary headache
* 7\. Has other significant pain problem that might confound the study assessments in the opinion of the investigator
* 8\. Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of transient ischemic attack (TIA) or cerebral vascular accident CVA), congestive heart failure (CHF), known severe coronary ar…
What they're measuring
1
Comparison of the Headache Pain Free Attack Rates at 15 Minutes Following the Treatment