A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache

Scion NeuroStim

Status

Completed

Conditions

Migraine Headache, Episodic

Treatments

Device: neuromodulation for episodic migraine headache

Study type

Interventional

Funder types

Industry

Identifiers

NCT01899040

SNS-MIG-01

Details and patient eligibility

About

This is a randomized, blinded study designed to assess the efficacy of a portable, non-invasive neuromodulation system for the treatment of episodic migraine headaches.

Full description

This is a multi-center, triple-blinded, placebo-controlled, randomized pivotal trial evaluating the adjunctive prophylactic treatment of episodic migraine headache using a caloric vestibular stimulation (CVS) device developed by Scion NeuroStim, LLC (SNS). This study has been reviewed by the FDA and is categorized as posing NSR (nonsignificant risk).

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient must have been diagnosed with episodic Migraine Headache at least 6 months prior to entering into the Study, consistent with the International Headache Classification of Headache Disorders-II (ICHD-II) guidelines.
The patient must have a history of at least three consecutive months of stable Migraine Headaches prior to entering the Study. The patients will not have had changes in medication usage for the three Months leading up to the Study, nor will they introduce new medications during the Study period. Patients will satisfy these criteria: On a Monthly basis, at least four, and not more than a total of fourteen (4-14), Headache Days (Pain Score between one and ten) of which between four and nine (4-14) are Migraine Headache Days
The patient must not have failed on more than two classes of properly administered prophylactic pharmaceutical therapies for migraine headache. The patient may be on a single migraine prophylactic as long as the dosage has not been altered within 3 months of starting the study and the dosage must not be altered for the duration of the study.
The Investigator must have confidence in the patient's ability to reliably use the Experimental Device and promptly complete the Daily Headache Diary forms. The Daily Headache Diary will be completed from the beginning of the Pre-Treatment Baseline Period through the end of the Pivotal Study.

Exclusion criteria

Individuals who:

are pregnant
have a history of cardiovascular disease
work night shifts
have been diagnosed with vestibular migraine
have been diagnosed with migraine with aura
have menstrual migraine exclusively
have been diagnosed with post-traumatic migraine
have a history of unstable mood disorder or unstable anxiety disorder
use a hearing aid
have a cochlear implant
have chronic tinnitus
have temporomandibular joint (TMJ) disease
have been diagnosed with traumatic brain injury (TBI)
have been diagnosed with neurological disease other than Headaches
have a diagnosed vestibular dysfunction
abuse alcohol or other drugs
are experiencing medication overuse Headaches (individuals with respect to whom the Investigator is concerned that analgesic abuse is involved based on the ICHD-II guidelines).
are younger than 18 years or older than 65 years
have had eye surgery within the previous three months or ear surgery within the previous six months
have active ear infections or a perforated tympanic membrane
have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
are using Botox treatments for migraines
Though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to using the Device. The Investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness to stimulation. Such medications should also be avoided within four hours prior to a treatment.