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

Scion NeuroStim

Status: Terminated

Conditions: Intervention

Treatments: Device: active neuromodulation for episodic migraine headache; Device: placebo neuromodulation for episodic migraine headache

Study type: Interventional

Funder types: Industry

Identifiers

NCT02991430

SNS-MIG-02

Details and patient eligibility

About

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

Full description

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).

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

active

Active Comparator group

Description:

active neuromodulation

Treatment:

Device: active neuromodulation for episodic migraine headache

placebo

Placebo Comparator group

Description:

placebo neuromodulation

Treatment:

Device: placebo neuromodulation for episodic migraine headache