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

Scion NeuroStim10 sites in 2 countries45 target enrollmentJune 30, 2017

ConditionsIntervention

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intervention
Sponsor: Scion NeuroStim
Enrollment: 45
Locations: 10
Primary Endpoint: Change in Migraine Headache Days (MHD)
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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).

Registry

clinicaltrials.gov

Start Date

June 30, 2017

End Date

May 11, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Scion NeuroStim

Responsible Party

Sponsor

Eligibility Criteria

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
•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

Outcomes

Primary Outcomes

Change in Migraine Headache Days (MHD)

Time Frame: 1 month of baseline recordation followed by 84 days of device use

comparison of MHD recorded in baseline month versus 3rd month of treatment

Secondary Outcomes

Change in Anxiety(1 month of baseline recordation followed by 84 days of device use)
Sustained Reduction in Migraine Headache Days(1 month of baseline recordation followed by 252 days of device use)
Change in Depression(1 month of baseline recordation followed by 84 days of device use)
Normalized Reduction in Migraine Headache Days(1 month of baseline recordation followed by 84 days of device use)
Change in Sleep Quality(1 month of baseline recordation followed by 84 days of device use)
Additional Treatment Time(1 month of baseline recordation followed by 168 days of device use)
Change in Medication Usage(1 month of baseline recordation followed by 84 days of device use)
Change in Headache Pain(1 month of baseline recordation followed by 84 days of device use)
Change in Quality of Life(1 month of baseline recordation followed by 84 days of device use)