Evaluation of a Wearable Device for Acute Treatment of Migraines

NCT07015125 | Completed FDA Device

• 1 other identifier: 1391996
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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 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

Keywords

Migraines; Acute Migraines; Headaches; Pain; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Safety/Adverse Events

  Safety will be measured by comparing the number of reportable adverse events, with particular focus on serious adverse events, that occur for the 6 active treatments versus the corresponding sham. Adverse events will be assessed by asking participants of any symptoms or medical issues experienced since the last interaction or activity in the study. Participants will report details of the event, its circumstances, the severity, and outcome/resolution of the event in the post-treatment surveys. The events will be adjudicated by the Study Physician, who will determine seriousness, relatedness and reportability.

  Pre-treatment, 1, 2, and 24 hours post-treatment.

• Pain Relief at 1 hour (Clinical Efficacy)

  Pain relief will be measured by asking participants to report pain intensity using the 11-point Numeric Rating Scale (NRS) in the pre-treatment survey and in the post-treatment survey 1 hour after the initiation of treatment. NRS pain levels will be converted into categorical ratings of pain severity according to the following mapping between NRS and a 4-point Likert scale: (0-1 NRS =\> no pain; 2-3 NRS =\> mild pain; 4-6 NRS =\> moderate pain; 7-10 NRS =\> severe pain). Pain relief constitutes a change in pain level from severe or moderate pain to mild or no pain. The percentage of participants who achieve pain relief in the active and sham treatments will be compared. Six comparisons will be performed in total, for the 6 active treatments (3 placements x 2 active waveforms).

  Pre-treatment, 1-hour post-treatment

Secondary Outcomes (3)

• Pain Relief at 2 hours

  Pre-treatment, 2 hours post-treatment

• Pain Freedom at 2 hours

  Pre-treatment, 1, 2 hours post-treatment.

• Sustained Pain Freedom

  24-hours post-treatment.

Study Arms (3)

Center of Forehead

EXPERIMENTAL

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.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Side of Forehead

EXPERIMENTAL

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.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Back of Neck

EXPERIMENTAL

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.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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

Also known as: Enso

Back of Neck; Center of Forehead; Side of Forehead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hinge Health, Inc: lead

Study Sites (1)

Hinge Health, Inc.

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache; Pain; Chronic Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Mallika Bariya, PhD

  Hinge Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: June 9, 2025
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)