COMPLETED

Evaluation of a Wearable Device for Acute Treatment of Migraines

Conditions

Migraine Migraine With or Without Aura Migraine, Acute Migraine Headache Migraines Acute Migraines Headaches Pain Chronic Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-09

Study Completion:2025-09-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT07015125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * 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.	* 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.

Inclusion Criteria

Exclusion 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:
* 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.

* 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.

Contacts and Locations

Principal Investigator

Mallika Bariya, PhD

PRINCIPAL_INVESTIGATOR

Hinge Health

Study Locations (Sites)

Hinge Health, Inc.

San Francisco, California, 94105

United States

Collaborators and Investigators

Sponsor: Hinge Health, Inc

Mallika Bariya, PhD, PRINCIPAL_INVESTIGATOR, Hinge Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-09

Study Completion Date2025-09-24

Study Record Updates

Study Start Date2025-06-09

Study Completion Date2025-09-24

Terms related to this study

Keywords Provided by Researchers

Migraines
Acute Migraines
Headaches
Pain
Chronic Pain

Additional Relevant MeSH Terms

Migraine
Migraine With or Without Aura
Migraine, Acute
Migraine Headache