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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of migraine with or without aura, identified via participant-provided medical records.

• Average migraine pain is 4 or more on the 0-10 Numerical Rating Scale (NRS) for pain.

• Passes ID-Migraine pre-screening questions and has ID-Migraine score ≥ 2:

• a. ID-Migraine pre-screening questions: i. How many headaches have participants experienced within the previous 3 months?

• Needs to be ≥ 6 headaches ii. Do the headaches that participants experience limit the ability to work, study, or enjoy life, or does the participant wish to speak with a healthcare professional about the headaches? (yes / no)

• Participant needs to respond yes b. ID-Migraine questions: i. Over the last 3 months, did participants have any of the following with headaches?

• Felt nauseated or sick to stomach (yes \[1\] / no \[0\])

• Light bothered them (a lot more than when headaches are not present)? (yes \[1\] / no \[0\])

• Headaches limited the ability to work, study, or do what needed to be done? (yes \[1\] / no \[0\])

• Able to understand and provide informed consent.

• Age 18 and older.

• US resident.

• Has experienced migraines for at least 1 year prior to recruitment.

• Onset of migraines occurred at age 50 years or younger.

• Average of at least 2 migraines per month of moderate to severe intensity.

• Is either on a) no medications or b) a stable dose of migraine-preventative medication for at least 2 months prior to recruitment.

• Willing to refrain from altering preventive medication for migraines (or from using botox), commit to using Enso as the first-line treatment, and wait at least 2 hours after Enso treatment before using any additional abortives during the study period.

• Participants must own an iPhone with iOS 15 or newer, or an Android phone with Android 9 or newer, with Bluetooth capability and access to either the Apple App Store (for iOS devices) or Google Play Store (for Android devices).

• Has an email account.

Locations
United States
California
Hinge Health, Inc.
RECRUITING
San Francisco
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2025-09
Participants
Target number of participants: 180
Treatments
Experimental: Center of Forehead
Participants will use the TENS device on the center of the forehead. Participants use 2 active and 1 sham waveform in a randomized order to treat 3 distinct migraine episodes.
Experimental: Side of Forehead
Participants will use the TENS device on the side of the forehead. Participants use 2 active and 1 sham waveform in a randomized order to treat 3 distinct migraine episodes.
Experimental: Back of Neck
Participants will use the TENS device on the back of the neck. Participants use 2 active and 1 sham waveform in a randomized order to treat 3 distinct migraine episodes.
Related Therapeutic Areas
Sponsors
Leads: Hinge Health, Inc

This content was sourced from clinicaltrials.gov