MigraineNCT07015125
Evaluation of a Wearable Device for Acute Treatment of Migraines
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Migraine and Migraine With or Without Aura, run by Hinge Health, Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Migraine With or Without Aura, Migraine, Acute
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2025to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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?
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Transcutaneous Electrical Nerve Stimulation Device for the Acute Treatment of Migraine
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.
Read the 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 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.
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Migraines, Acute Migraines, Headaches, Pain, Chronic Pain
- Medical subject headings
- Migraine Disorders, Headache, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Also called Enso
Use of TENS device for 1 hour during each migraine episode.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Pre-treatment, 1-hour post-treatment
Secondary outcomes (3)
Pain Relief at 2 hours
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 2 hours 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).
Measured: Pre-treatment, 2 hours post-treatment
Pain Freedom at 2 hours
Pain freedom will be defined as a reduction in pain severity from mild, moderate, or severe at baseline to none at 2 hours, using the Numeric Rating Scale (NRS) mapped to a 4-point Likert scale, as based on literature. Six comparisons will be performed in total, for the 6 active treatments (3 placements x 2 active waveforms) vs the corresponding sham.
Measured: Pre-treatment, 1, 2 hours post-treatment.
Sustained Pain Freedom
Sustained pain freedom is defined as pain freedom at 24 hours without the use of anti-migraine medication or relapse during those 24 hours. Sustained pain freedom at 24 hours will be measured using the same four point Likert scale as used to measure pain freedom at 2 hours. Six comparisons will be performed in total, for the 6 active treatments (3 placements x 2 active waveforms) vs the corresponding sham.
Measured: 24-hours post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start9 Jun 2025
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hinge Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mallika Bariya, PhD, Principal investigator, Hinge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015125
- Sponsor's protocol ID
- 1391996
- Status last verified
- Oct 2025
- First submitted
- 3 Jun 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Transcutaneous Electrical Nerve Stimulation Device for the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT07015125
- Acronym / sponsor ID
- 1391996
- Keywords
- Migraines, Acute Migraines, Headaches, Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hinge Health, IncIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Center of Forehead | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)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. |
| Side of Forehead | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)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. |
| Back of Neck | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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?
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS)Also: EnsoUse of TENS device for 1 hour during each migraine episode. | Device | Back of Neck, Center of Forehead, Side of Forehead |
Primary outcome
Safety/Adverse Events
Time frame: Pre-treatment, 1, 2, and 24 hours post-treatment.
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.
Pain Relief at 1 hour (Clinical Efficacy)
Time frame: Pre-treatment, 1-hour post-treatment
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).
3 secondary outcomes
Pain Relief at 2 hours
Time frame: Pre-treatment, 2 hours post-treatment
Pain Freedom at 2 hours
Time frame: Pre-treatment, 1, 2 hours post-treatment.
Sustained Pain Freedom
Time frame: 24-hours post-treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mallika Bariya, PhD principal investigator
Hinge Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Migraine and Migraine With or Without Aura, run by Hinge Health, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/Adverse Events (time frame: Pre-treatment, 1, 2, and 24 hours post-treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.