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.
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.
| Condition | Headache |
|---|---|
| Treatment | eNeura SpringTMS |
| Clinical Study Identifier | NCT02357381 |
| Sponsor | eNeura, Inc. |
| Last Modified on | 21 January 2021 |
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