Clinical trial NCT07015125: Evaluation of a Wearable Device for Acute Treatment of Migraines
Official title: A Randomized Controlled Trial of a Transcutaneous Electrical Nerve Stimulation Device for the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine
Migraine With or Without Aura
Migraine, Acute
Migraine Headache
Keywords: Migraines
Acute Migraines
Headaches
Pain
Chronic Pain
Lead sponsor: Hinge Health, Inc
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study will be a randomized, controlled trial with a 3x3 factorial design (3 placements x 3 waveforms). Participants will be randomized to use the TENS device in one of three different placement locations. Each participant will test a total of 3 waveforms (two active waveforms and a sham waveform) in a randomized order over three distinct migraine episodes, with a 3-day washout period in between each treated migraine.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine the efficacy of a new, improved neuromodulation device that can be worn on the forehead or back of the 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 (on the center of the forehead, side of the forehead, or at the suboccipital region on the back of the neck) 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.

Eligibility criteria: 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 epilepsy.
* Has a history of major cardiovascular events such as strokes, arrhythmias, or myocardial infarction.
* Has a history of major migraine complications such as migrainous infarction or migraine aura-triggered seizure
* Diagnosed with secondary headache disorders including medication overuse headaches
* History of opioid, alcohol, or drug abuse in the last 1 year.
* Has a cardiac pacemaker, implanted defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other implanted electronic device.
* Has a metal implant in the upper extremities or head.
* Has a history of major head or neck surgeries.
* Pregnant.
* Currently participating or has participated in a study with an investigational compound or device within the last 30 days before the screening visit.
* Currently using a TENS device to treat migraines.
* Received supraorbital nerve blocks or Botox treatment within 4 months prior to recruitment.
* Insufficient proficiency with the English language to take part in study procedures or complete online surveys.
* Planning to travel outside of the US within three months after consenting to the study.

Primary outcomes:
measure: Safety/Adverse Events
timeFrame: Pre-treatment, 1, 2, and 24 hours post-treatment.
measure: Pain Relief at 1 hour (Clinical Efficacy)
timeFrame: Pre-treatment, 1-hour post-treatment
Secondary outcomes:
measure: Pain Relief at 2 hours
timeFrame: Pre-treatment, 2 hours post-treatment
measure: Pain Freedom at 2 hours
timeFrame: Pre-treatment, 1, 2 hours post-treatment.
measure: Sustained Pain Freedom
timeFrame: 24-hours post-treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Hinge Health
name: Mallika Bariya, PhD
role: PRINCIPAL_INVESTIGATOR
References: