A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache

A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache

This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.

This study is a multi-center, triple-blinded, placebo-controlled, randomized clinical trial for adjunctive prophylactic treatment of episodic migraine headache (with or without aura) using neuromodulation device developed by Scion NeuroStim, LLC (SNS). The investigational use of the device for episodic migraine headache has been reviewed by the FDA and is classified as NSR (non-significant risk).

Inclusion Criteria:

• diagnosed with episodic migraine at least 6 months before study
• at least 3 consecutive months of stable migraine headaches before study
• at least 4-14 headache days per month, of which 4-14 may be migraines
• must not have failed on more than 2 classes of migraine preventatives

Exclusion Criteria:

• previous use of the experimental device
• pregnant
• using more than 1 concurrent migraine preventive
• history of cardiovascular disease
• work night shifts
• diagnosed with vestibular migraine
• menstrual migraines exclusively
• diagnosed with post-traumatic migraine
• have a history of unstable mood or anxiety disorder
• use a hearing aid
• have a cochlear implant
• have chronic tinnitus
• have temporomandibular joint disease
• diagnosed with traumatic brain injury
• diagnosed with neurological disease other than headaches
• diagnosed vestibular and/or balance dysfunction
• history of abusing alcohol or other drugs
• are experiencing medication overuse headaches
• have had eye surgery in the previous 3 months
• have had ear surgery in the previous 6 months
• have active ear infections or a perforated tympanic membrane
• have participated in another clinical trial in the last 30 days
• are currently participating in another clinical trial
• using Botulinum toxin-based treatments for migraines or cosmetic reasons
• taking anti-emetics more than 2 times per week (consistently)