Trials / Completed
CompletedNCT03631550
The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 187 (actual)
- Sponsor
- Neurolief Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
this study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relivion®)
Detailed description
The Relivion® is a non-invasive transcutaneous neuro-stimulator is indicated for the acute treatment of migraine with or without aura in subjects 18 years of age or older. The Relivion® is intended to be a prescription device, self-used at home.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Relivion active | 1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation |
| DEVICE | Relivion Sham | 1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation |
Timeline
- Start date
- 2018-11-29
- Primary completion
- 2020-08-04
- Completion
- 2020-08-04
- First posted
- 2018-08-15
- Last updated
- 2022-09-22
- Results posted
- 2022-07-12
Locations
12 sites across 2 countries: United States, Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03631550. Inclusion in this directory is not an endorsement.