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Evaluation of a Wearable Device for Acute Treatment of Migraines

NCT07015125 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-10-30

No results posted yet for this study

Summary

The goal of this clinical trial is to determine the efficacy of a new, improved neuromodulation device that can be worn on the head and neck to relieve migraine pain. To measure efficacy, investigators will compare how measured outcomes resulting from active stimulation with this device compare to those of sham treatment.

Conditions

  • Migraine
  • Migraine With or Without Aura
  • Migraine, Acute
  • Migraine Headache

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS)

Use of TENS device for 1 hour during each migraine episode.

Sponsors & Collaborators

  • Hinge Health, Inc

    lead INDUSTRY

Principal Investigators

  • Mallika Bariya, PhD · Hinge Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2025-09-24
Completion
2025-09-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07015125 on ClinicalTrials.gov