Investigating how the timing of Nerivio treatment affects migraine relief
The Effect of Treatment Onset Time on Acute Treatment Efficacy in Migraine Patients Using Remote Electrical Neuromodulation (REN)
This study is testing if using the Nerivio device at different times during a migraine can help people feel better and reduce their pain.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70000 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | Theranica Industry-sponsored |
| Locations | 1 site (Bridgewater, New Jersey) |
| Trial ID | NCT06976723 on ClinicalTrials.gov |
What this trial studies
This post-marketing study evaluates the efficacy of the Nerivio device for acute migraine treatment based on the timing of treatment onset. Participants will use the Nerivio device, a wearable neuromodulation device, to manage their migraine symptoms. Efficacy will be measured by assessing changes in headache pain severity and functional disability from baseline to two hours post-treatment. The study aims to determine if starting treatment at different times during a migraine attack influences the effectiveness of the device.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 8 years and older who experience migraines and have reported treatment onset times using the Nerivio app.
Not a fit: Patients who are using medications for acute migraine treatment during the study may not benefit from this approach.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing treatment timing for better migraine relief using the Nerivio device.
How similar studies have performed: Other studies on neuromodulation devices have shown promising results, suggesting that this approach may be effective, although the specific timing aspect is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Users who had reported treatment onset time in at least one treatment through the REN companion smartphone app Exclusion Criteria: * • Treatments that included medications for acute treatment of migraine
Where this trial is running
Bridgewater, New Jersey
- Theranica Bio-Electronics Inc — Bridgewater, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Dagan Harris, PhD
- Email: daganh@theranica.com
- Phone: 00972542220121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.