NCT02357381

eNeura SpringTMS Post-Market Observational US Study of Migraine

eNeura SpringTMS Post-Market Observational U.S. Study of Migraine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 263 (actual)
• Sponsor: eNeura, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Headache

Interventions

Type	Name	Description
DEVICE	eNeura SpringTMS	Single pulse magnetic stimulation for prevention and/or treatment of migraine headache with or without aura.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-02-06
• Last updated: 2021-06-18

Locations

7 sites across 1 country: United States