Evaluation of a Wearable Device for Acute Treatment of Migraines
CompletedNot applicableNCT07015125
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Randomized Controlled Trial of a Transcutaneous Electrical Nerve Stimulation Device for the Acute Treatment of Migraine
- Conditions
- Migraine
- Migraine With or Without Aura
- Migraine, Acute
- Migraine Headache
- Sponsor
- Hinge Health, Inc
- Start date
- 2025-06-09
- Primary completion
- 2025-09-24
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * Typical migraine pain is \< 4 out of 10 on the 0-10 NRS. * Currently institutionalized. * Currently is or has ever been a Hinge Health member. * Use of antipsychotic medication up to 3 months before study recruitment. * Diagnosis of cancer/malignant tumors in the last 5 years. * Cognitive, behavioral, neurologic, or psychiatric disorder (e.g., dementia, Parkinson's, schizophrenia, stroke) that may interfere with the study or prevent the subject from complying with the requirements of the protocol. * Has …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07015125