Trials / Active Not Recruiting
Active Not RecruitingNCT06167655
A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM
A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM IN RELIEVING, INTERRUPTING, AND PREVENTING CHRONIC MIGRAINE (RELIEV-CM2)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- ShiraTronics · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multi-center, double blind, randomized, sham-controlled study to evaluate neuromodulation in patient with chronic migraine. The study hypothesis to be tested is the mean reduction in mean monthly headache days between patients in treatment versus sham.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Neurostimulator | Neurostimulation system that applies stimulation to nerve pathways in the head associated with migraine symptoms. |
Timeline
- Start date
- 2024-05-29
- Primary completion
- 2027-03-01
- Completion
- 2031-05-01
- First posted
- 2023-12-12
- Last updated
- 2026-04-14
Locations
23 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06167655. Inclusion in this directory is not an endorsement.