Evaluation of a Wearable Device for Acute Treatment of Migraines
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Phase
Not applicable
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
160actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-09 | actual | When the study began enrolling |
| Primary completion | 2025-09-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-24 | actual | The whole study's end, after follow-up |
| First posted | 2025-06-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Migraine
- Migraine With or Without Aura
- Migraine, Acute
- Migraine Headache
Intervention
- Device: Transcutaneous Electrical Nerve Stimulation (TENS) — also filed as Enso
Primary outcomes
what the primary-completion date above is the date OFSafety/Adverse Events
measured Pre-treatment, 1, 2, and 24 hours post-treatment.
Pain Relief at 1 hour (Clinical Efficacy)
measured Pre-treatment, 1-hour post-treatment
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