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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Intervention

In brief

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

Key facts

Study ID

NCT02991430

Run by

Scion NeuroStim

People needed

45

Starts

2017-06-30

Expected to finish

2018-05-11

Last updated by the study team

2019-06-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Neurology Research Institute — West Palm Beach, Florida, United States
• Diamond Headache Clinic — Chicago, Illinois, United States
• Michigan Headache Pain & Neurological Inst. — Ann Arbor, Michigan, United States
• Study Metrix Research — City of Saint Peters, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Jefferson Headache Center — Philadelphia, Pennsylvania, United States
• King's College London — London, Denmark Hill, United Kingdom
• University of Kent — Canterbury, Kent, United Kingdom

Full record on ClinicalTrials.gov

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