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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2018-05-11

Brief Summary

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

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Detailed Description

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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).

Conditions

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Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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active

active neuromodulation

Group Type ACTIVE_COMPARATOR

active neuromodulation for episodic migraine headache

Intervention Type DEVICE

Non-invasive brainstem neuromodulator. Active and placebo devices appear identical

placebo

placebo neuromodulation

Group Type PLACEBO_COMPARATOR

placebo neuromodulation for episodic migraine headache

Intervention Type DEVICE

Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical

Interventions

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active neuromodulation for episodic migraine headache

Non-invasive brainstem neuromodulator. Active and placebo devices appear identical

Intervention Type DEVICE

placebo neuromodulation for episodic migraine headache

Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No