NCT07015125

Evaluation of a Wearable Device for Acute Treatment of Migraines

A Randomized Controlled Trial of a Transcutaneous Electrical Nerve Stimulation Device for the Acute Treatment of Migraine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Hinge Health, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of this study is to examine the extent to which a transcutaneous electrical nerve stimulation (TENS) device safely helps participants with acute migraines reduce migraine pain intensity, achieve pain freedom, and experience sustained pain freedom. The TENS device attaches to a gel pad that can be worn in one of three placement locations to stimulate sensory nerves implicated in migraine pain. The TENS device outputs two active electrical waveforms that differ in stimulation intensity but can both be used to address migraine pain through a 1-hour treatment session. To achieve the study objective, investigators will perform a randomized controlled trial (RCT) with a 3x3 factorial design in which participants will be randomized across the 3 TENS device placement options and each participant will test 3 waveforms: two active waveforms and a sham waveform. Each waveform will be used in a distinct migraine episode. The investigators will evaluate the study aims for each active treatment (six in total) compared to its corresponding sham.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Transcutaneous Electrical Nerve Stimulation (TENS)	Use of TENS device for 1 hour during each migraine episode.

Timeline

• Start date: 2025-06-09
• Primary completion: 2025-09-24
• Completion: 2025-09-24
• First posted: 2025-06-11
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study