NCT02991430

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Scion NeuroStim · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Intervention

Interventions

Type	Name	Description
DEVICE	active neuromodulation for episodic migraine headache	Non-invasive brainstem neuromodulator. Active and placebo devices appear identical
DEVICE	placebo neuromodulation for episodic migraine headache	Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical

Timeline

• Start date: 2017-06-30
• Primary completion: 2018-05-11
• Completion: 2018-05-11
• First posted: 2016-12-13
• Last updated: 2019-06-19
• Results posted: 2019-06-19

Locations

10 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study