MigraineNCT07642414
A Comprehensive Digital Care Program for Migraine Management
A study testing Neuromodulation Wearable Device and Migraine Digital Care Program in people with Migraine and Migraine With Aura, run by Hinge Health, Inc at 1 site in United States.
Trial summary
This study evaluates the clinical effectiveness of the Enso for Migraine program, a comprehensive digital care program combining an FDA-cleared neuromodulation wearable device (Enso), personalized exercise therapy, and a dedicated care team, in reducing migraine frequency among adults with episodic or chronic migraine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Migraine With Aura, Migraine Without Aura
- What is being tested?
- Neuromodulation Wearable Device and Migraine Digital Care Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years of age or older
- Documented or clinical history of episodic or chronic migraine (with or without aura) for at least 12 months, consistent with ICHD-3 criteria. Verification of diagnosis must be established using one or more of the following methods: participant-provided medical records, documented pharmacy prescription history, or validated diagnostic screening instruments.
- Passes ID-Migraine Screener with a score of 2 or more "yes" answers to the following question: During the last 3 months, did you experience any of the following with your migraines? (1) Your migraines limited your ability to complete your daily activities for more than one day; (2) You felt nauseated or sick to your stomach; (3) Light bothered you (a lot more than when you don't have migraines).
- Migraine onset occurred at age 50 years or younger
- Minimum of 4 migraine days during the 28-day baseline run-in period, as confirmed by the study eDiary
- At least 80% eDiary compliance (minimum of 22 out of 28 days) during the prospective baseline run-in period
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- Currently on a stable dose of traditional oral migraine preventive medication (e.g., topiramate, beta-blockers, amitriptyline) for at least 90 days prior to the start of the 28-day baseline period, or taking no preventive medication
- Currently on a stable dose of CGRP monoclonal antibodies (e.g., Aimovig, Emgality, Ajovy, Vyepti) or OnabotulinumtoxinA (Botox) for at least 180 days (6 months) prior to the start of the 28-day baseline period
- Willingness to maintain current preventive and as-needed (acute) medication regimens (e.g., triptans, NSAIDs, or abortive gepants) and refrain from initiating any brand new pharmacological or clinical treatments (e.g., nerve blocks, Botox, or infusions) for the duration of the 12-week intervention period
- Sufficient physical mobility to engage with the exercise therapy component of the program, with or without reasonable accommodations; participants reporting significant mobility restrictions (e.g., wheelchair use) will be eligible pending a clinical safety review by a Study Physician or Physical Therapist
- Active commercial health insurance coverage (either as the primary policyholder or a covered dependent) through an employer-sponsored health plan, commercial health insurer, or an affiliated benefit partner eligible for digital health solution deployment
- US resident
- Has a valid email account
- Personal ownership of a smartphone (iOS 15 or later, or Android 10 or later) with Bluetooth capability, app store access, and compatibility with the eDiary
- Able to understand and provide voluntary informed consent
Who cannot join
- Presence of a cardiac pacemaker, implanted or wearable defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other active implanted electronic medical device
- Presence of a metal implant in the head or neck (excluding dental work)
- Supraorbital nerve blocks or infusion treatments for migraine received within 4 months before the start of the baseline period
- Presence of other primary or secondary headache disorders (e.g., cluster headache, New Daily Persistent Headache, or post-traumatic headache); Note: Medication Overuse Headache (MOH) is NOT an exclusion criterion
- History of major head or neck injuries or any physical condition (e.g., severe cervical spine instability) that, in the opinion of the Principal Investigator and/or Study Physician, would make the exercise therapy component of the program unsafe; History of major cardiovascular events (e.g., stroke, arrhythmia, myocardial infarction)
- History of major migraine complications (e.g., migrainous infarction or aura-triggered seizure)
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- Presence of fever, chills, or night sweats lasting five or more days and not improving
- Significant change in headache pattern, including headaches that are becoming much more severe or frequent, represent a new type of pain, wake the participant from sleep, or worsen with positional changes (e.g., coughing, bearing down, or changing position)
- Recent changes in vision, mental status, sensation, or strength; or new onset of jaw pain or neck stiffness
- Unexplained significant weight loss (past 3 months), or persistent weakness/numbness in the extremities (past 3 months)
- Known history of conditions that may compromise the immune system
- Head trauma within the past 2 weeks or diagnosis of a spinal fracture or shoulder dislocation within the past 3 months
- Any major trauma, fracture, or significant injury (e.g., car accident, sports injury) within the past 3 months
- Any major surgery within the past 3 months
- Inability to stand up from a chair without assistance (unless the participant utilizes a wheelchair and has been cleared via PT review)
- History of falling due to balance, weakness, vision, or other physical limitations within the past 3 months
- Current diagnosis of epilepsy or active malignancy (history of cancer within the last 5 years)
- Presence of a cognitive or neurological disorder (e.g., dementia, Parkinson's disease) that may interfere with study participation
- Currently unmanaged psychiatric disorder (e.g., schizophrenia, substance abuse, or severe major depressive disorder/anxiety) that, in the opinion of the investigator, could prevent compliance with study instructions
- Pregnant, planning to become pregnant during the study, or currently breastfeeding
- Currently institutionalized
- Insufficient proficiency with the English language to take part in study procedures or complete online surveys
- Current or previous enrollment in any Hinge Health Program or participation in prior Hinge Health research studies
- Current ownership or previous use of an Enso device or other prescribed high-frequency electrical stimulation therapy for the treatment of pain
- Participation in an investigational study within 30 days prior to screening
- Planned travel outside of the U.S. within the first month of enrollment
- Current employees or contractors of Hinge Health, Inc. or L\&E Research, and their immediate family members
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of a Comprehensive Digital Care Program for Migraine: A Prospective, Single-Arm, Pilot Study
This study evaluates the clinical effectiveness of the Enso for Migraine program, a comprehensive digital care program combining an FDA-cleared neuromodulation wearable device (Enso), personalized exercise therapy, and a dedicated care team, in reducing migraine frequency among adults with episodic or chronic migraine.
Read the detailed description
The Enso for Migraine program is a comprehensive digital care intervention consisting of: (1) an FDA-cleared neuromodulation wearable device for acute migraine pain relief; (2) guided exercise therapy playlists for migraine prevention; (3) a dedicated care team including a licensed physical therapist and health coach accessible through the Hinge Health app; (4) guided breathing exercises for relaxation and stress reduction; and (5) an in-app migraine trigger tracking journal and education library supporting behavioral awareness and self-management.
The study uses a prospective, single-arm, open-label design with within-subject comparison. Participants first complete a 28-day electronic diary (eDiary) baseline run-in period (weeks -4 to -1). Participants who log at least 4 migraine days and achieve at least 80% diary compliance (22 of 28 days) during the baseline period proceed to a 12-week intervention phase (weeks 1-12) with full program access. Participants continue daily eDiary throughout the intervention phase.
The primary objective is to evaluate the reduction in Monthly Migraine Days (MMDs) from the 28-day baseline to the final 28 days of the intervention (weeks 9-12). Secondary objectives include assessments of headache impact, work productivity, acute pain relief, and migraine responder rates.
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Being tested
- Neuromodulation Wearable Device, Migraine Digital Care Program
- Keywords
- migraine, transcutaneous electrical nerve stimulation, neuromodulation, digital health, exercise therapy
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromodulation Wearable DeviceDevice
The Neuromodulation Wearable Device is an FDA-cleared (510(k)) Class II neuromodulation wearable used for acute migraine treatment. Participants use the device to treat migraine attacks as needed during the 12-week intervention phase.
Migraine Digital Care ProgramOther
A comprehensive digital care program delivered via the Hinge Health app, consisting of: (1) guided exercise therapy playlists targeting migraine prevention through structured physical activity; (2) a dedicated care team including a licensed physical therapist and health coach supporting clinical progress, adherence, and behavioral modification; (3) guided breathing exercises for relaxation and stress reduction; (4) in-app migraine trigger tracking allowing participants to log lifestyle, dietary, environmental, and hormonal factors associated with their episodes; and (5) a migraine-specific education library covering triggers, lifestyle modifications, sleep hygiene, and pain management strategies.
| Study group | Role | What they receive |
|---|---|---|
| Digital Care Program for Migraine Management | Experimental | Participants complete a 28-day electronic diary (eDiary) baseline run-in period (weeks -4 to -1) and, if eligible, receive 12 weeks of access to the digital care program (weeks 1-12). Participants continue daily eDiary throughout the intervention phase. The program combines the FDA-cleared neuromodulation wearable device for acute migraine treatment with a digital care program delivered via the Hinge Health app. Receives: Device: Neuromodulation Wearable Device; Other: Migraine Digital Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Monthly Migraine Days (MMDs)
A migraine day is defined per ICHD-3 criteria as a calendar day with headache lasting at least 4 hours (untreated or unsuccessfully treated) with moderate-to-severe pain intensity, accompanied by nausea/vomiting or photophobia/phonophobia. Monthly Migraine Days are counted over a 28-day period using daily electronic diary data.
Measured: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
Secondary outcomes (7)
50% Responder Rate
Measured: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
Mean Change in Monthly Headache Days (MHDs)
Measured: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
Mean Change in Migraine Pain Intensity (NRS)
Measured: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
Mean Change in Average Migraine Attack Duration
Measured: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
Mean Change in Headache Impact Test-6 (HIT-6) Score
Measured: Baseline, Week 4, Week 8, Week 12
Proportion Achieving Acute Pain Relief at 2 Hours Post-Treatment
Measured: During 12-week intervention phase
Proportion Achieving Acute Pain Freedom at 2 Hours Post-Treatment
Measured: During 12-week intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start9 Jul 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hinge Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642414
- Sponsor's protocol ID
- HH-2026-COM-MIG
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2026
- Last updated
- 17 Sep 2026
- Results posted
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Comprehensive Digital Care Program for Migraine: A Prospective, Single-Arm, Pilot Study
- ClinicalTrials.gov ID
- NCT07642414
- Acronym / sponsor ID
- HH-2026-COM-MIG
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Keywords
- migraine, transcutaneous electrical nerve stimulation, neuromodulation, digital health, exercise therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hinge Health, IncIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Jun 2026 (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.
This study evaluates the clinical effectiveness of the Enso for Migraine program, a comprehensive digital care program combining an FDA-cleared neuromodulation wearable device (Enso), personalized exercise therapy, and a dedicated care team, in reducing migraine frequency among adults with episodic or chronic migraine.
Detailed description
The Enso for Migraine program is a comprehensive digital care intervention consisting of: (1) an FDA-cleared neuromodulation wearable device for acute migraine pain relief; (2) guided exercise therapy playlists for migraine prevention; (3) a dedicated care team including a licensed physical therapist and health coach accessible through the Hinge Health app; (4) guided breathing exercises for relaxation and stress reduction; and (5) an in-app migraine trigger tracking journal and education library supporting behavioral awareness and self-management.
The study uses a prospective, single-arm, open-label design with within-subject comparison. Participants first complete a 28-day electronic diary (eDiary) baseline run-in period (weeks -4 to -1). Participants who log at least 4 migraine days and achieve at least 80% diary compliance (22 of 28 days) during the baseline period proceed to a 12-week intervention phase (weeks 1-12) with full program access. Participants continue daily eDiary throughout the intervention phase.
The primary objective is to evaluate the reduction in Monthly Migraine Days (MMDs) from the 28-day baseline to the final 28 days of the intervention (weeks 9-12). Secondary objectives include assessments of headache impact, work productivity, acute pain relief, and migraine responder rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Care Program for Migraine Management | Experimental | Device: Neuromodulation Wearable Device, Other: Migraine Digital Care ProgramParticipants complete a 28-day electronic diary (eDiary) baseline run-in period (weeks -4 to -1) and, if eligible, receive 12 weeks of access to the digital care program (weeks 1-12). Participants continue daily eDiary throughout the intervention phase. The program combines the FDA-cleared neuromodulation wearable device for acute migraine treatment with a digital care program delivered via the Hinge Health app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 18 years of age or older
- Documented or clinical history of episodic or chronic migraine (with or without aura) for at least 12 months, consistent with ICHD-3 criteria. Verification of diagnosis must be established using one or more of the following methods: participant-provided medical records, documented pharmacy prescription history, or validated diagnostic screening instruments.
- Passes ID-Migraine Screener with a score of 2 or more "yes" answers to the following question: During the last 3 months, did you experience any of the following with your migraines? (1) Your migraines limited your ability to complete your daily activities for more than one day; (2) You felt nauseated or sick to your stomach; (3) Light bothered you (a lot more than when you don't have migraines).
- Migraine onset occurred at age 50 years or younger
- Minimum of 4 migraine days during the 28-day baseline run-in period, as confirmed by the study eDiary
Key exclusion criteria (27 listed)
- Presence of a cardiac pacemaker, implanted or wearable defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other active implanted electronic medical device
- Presence of a metal implant in the head or neck (excluding dental work)
- Supraorbital nerve blocks or infusion treatments for migraine received within 4 months before the start of the baseline period
- Presence of other primary or secondary headache disorders (e.g., cluster headache, New Daily Persistent Headache, or post-traumatic headache); Note: Medication Overuse Headache (MOH) is NOT an exclusion criterion
- History of major head or neck injuries or any physical condition (e.g., severe cervical spine instability) that, in the opinion of the Principal Investigator and/or Study Physician, would make the exercise therapy component of the program unsafe; History of major cardiovascular events (e.g., stroke, arrhythmia, myocardial infarction)
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 |
|---|---|---|
| Neuromodulation Wearable DeviceThe Neuromodulation Wearable Device is an FDA-cleared (510(k)) Class II neuromodulation wearable used for acute migraine treatment. Participants use the device to treat migraine attacks as needed during the 12-week intervention phase. | Device | Digital Care Program for Migraine Management |
| Migraine Digital Care ProgramA comprehensive digital care program delivered via the Hinge Health app, consisting of: (1) guided exercise therapy playlists targeting migraine prevention through structured physical activity; (2) a dedicated care team including a licensed physical therapist and health coach supporting clinical progress, adherence, and behavioral modification; (3) guided breathing exercises for relaxation and stress reduction; (4) in-app migraine trigger tracking allowing participants to log lifestyle, dietary, environmental, and hormonal factors associated with their episodes; and (5) a migraine-specific education library covering triggers, lifestyle modifications, sleep hygiene, and pain management strategies. | Other | Digital Care Program for Migraine Management |
Primary outcome
Mean Change in Monthly Migraine Days (MMDs)
Time frame: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
A migraine day is defined per ICHD-3 criteria as a calendar day with headache lasting at least 4 hours (untreated or unsuccessfully treated) with moderate-to-severe pain intensity, accompanied by nausea/vomiting or photophobia/phonophobia. Monthly Migraine Days are counted over a 28-day period using daily electronic diary data.
7 secondary outcomes
50% Responder Rate
Time frame: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
Mean Change in Monthly Headache Days (MHDs)
Time frame: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
Mean Change in Migraine Pain Intensity (NRS)
Time frame: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
Mean Change in Average Migraine Attack Duration
Time frame: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
Mean Change in Headache Impact Test-6 (HIT-6) Score
Time frame: Baseline, Week 4, Week 8, Week 12
Proportion Achieving Acute Pain Relief at 2 Hours Post-Treatment
Time frame: During 12-week intervention phase
Proportion Achieving Acute Pain Freedom at 2 Hours Post-Treatment
Time frame: During 12-week intervention phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromodulation Wearable Device and Migraine Digital Care Program in people with Migraine and Migraine With 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 15 inclusion and 27 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: enrolling by invitation, as of the sponsor's last update on 17 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mean Change in Monthly Migraine Days (MMDs) (time frame: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)). 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 17 Sep 2026.