eNeura SpringTMS Post-Market Observational US Study of Migraine

  • STATUS
    Not Recruiting
  • participants needed
    250
  • sponsor
    eNeura, Inc.
Updated on 21 January 2021
migraine

Summary

A multi-center, prospective, non-randomized, single arm, open label, post-market, observational study to evaluate the use of the eneura, springtms system in reduction of migraine headache symptoms.

Description

A prospective, non-randomized, single arm, multi-center observational study designed to evaluate the use of the SpringTMS system in reducing the frequency of headache days. Note: This is a NON-SIGNIFICANT RISK (NSR) study of a NON-SIGNIFICANT RISK (NSR) Device. It is a post market study of a NSR device cleared by FDA through the 510(k) pre-market notification process. The cleared indications for use are provided above. This NSR study is designed to collect information on additional applications of the SpringTMS device. These additional applications include: 1. Use of the device to evaluate the potential for regular use of sTMS to reduce the frequency, severity, and/or duration of migraine. 2. Delivery of additional treatments (pulses) to evaluate the acute treatment efficacy of breakthrough migraine attacks with and without aura.

Details
Condition Headache
Treatment eNeura SpringTMS
Clinical Study IdentifierNCT02357381
SponsoreNeura, Inc.
Last Modified on21 January 2021

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