MigrainePhase 4NCT07336420
Treatment Patterns Among US Veterans Using Remote Electrical Neuromodulation (REN) for Migraine Treatment
A Phase 4 study testing Nerivio REN device in people with Migraine and Acute Treatment of Migraine, run by Theranica at 1 site in United States.
Trial summary
Among US veterans, migraine is a prevalent and disabling neurological disorder, creating a clinical need for effective treatment options. This real-world evidence (RWE) study assessed the use, effectiveness, and safety of the REN wearable for the acute treatment of migraine among veterans, with a primary focus on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Acute Treatment of Migraine
- What is being tested?
- Nerivio REN device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2026to 30 Jan 2026
- Phase
- Phase 4
- 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
- VA patients who were prescribed the Nerivio REN device
- Performed at least 2 REN treatments with both baseline and 2-hours reports
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Theranica Bio-Electronics Inc
Bridgewater, New Jersey, 08807
About this study
Official title: Treatment Patterns, Medication Usage, Effectiveness, and Safety Among US Veterans Using the Remote Electrical Neuromodulation (REN) Wearable Device for Migraine Treatment
Among US veterans, migraine is a prevalent and disabling neurological disorder, creating a clinical need for effective treatment options.
This real-world evidence (RWE) study assessed the use, effectiveness, and safety of the REN wearable for the acute treatment of migraine among veterans, with a primary focus on whether they need rescue medications following REN treatment. Findings from this study may help guide clinical decision-making as veterans and providers craft treatment plans that include non-pharmacologic options.
Read the detailed description
Migraine is a highly prevalent and disabling neurological disorder characterized by recurrent headache attacks often accompanied by nausea, sensitivity to light or sound, and functional impairment. Affecting approximately 14% of the global population, migraine substantially reduces quality of life and interferes with daily functioning.
Within the veteran affairs (VA) population in the United States, headache disorders including migraine, are particularly common, and their diagnosis has increased throughout the years. In this population, headache disorders commonly develop following service-related injuries or exposures, such as service eras and traumatic brain injury (TBI), contributing their prevalence and severity. Moreover, veterans with headache disorders frequently present with multiple comorbidities, including post-traumatic stress disorder (PTSD), depression, anxiety, sleep disorders, chronic musculoskeletal pain, neck and back disorders, and TBI-related symptoms. This complex clinical profile increases disability, complicates treatment decisions, and can limit the use of certain pharmacologic therapies due to contraindications or polypharmacy.
Despite the availability of multiple therapeutic options, many patients face challenges in managing their migraine due to limited drug tolerability, contraindications, or medication-overuse headache (MOH). These challenges are particularly pronounced among veterans where comorbid conditions and polypharmacy often complicate or restrict pharmacological therapeutic options highlighting the need for effective, well-tolerated, non-pharmacological alternatives. Demonstrating effective pain, functional impairment, and symptom freedom or relief, with minimal reliance on additional medications, is particularly relevant in this population. This need is supported by the adoption of non-pharmacological treatment options by the Veterans Health Administration (VHA).
Remote electrical neuromodulation (REN) is a prescribed wearable device for non-invasive, non-pharmacological treatment of migraine, indicated for acute and/or preventive treatment in patients aged 8 years and older. Many studies, including randomized controlled trials and real-world evidence studies, have shown the efficacy and safety of the REN wearable device in treating migraine pain and associated symptoms.
This real-world evidence (RWE) study assessed the use, effectiveness, and safety of the REN wearable for the acute treatments of migraine among veterans, with a primary focus on whether they need rescue medications following REN treatment, as well as on treatment effectiveness.
- Conditions
- Migraine, Acute Treatment of Migraine
- Being tested
- Nerivio REN device
- Keywords
- Nerivio, Remote Electrical Neuromodulation, Acute Treatment of Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerivio REN deviceDevice
Remote electrical neuromodulation (REN) wearable device for the acute treatment of migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
| Study group | Role | What they receive |
|---|---|---|
| Nerivio treatment | Active comparator | VA patients who were prescribed the REN wearable device and had at least 2 treatments with reports on baseline and 2-hours post-treatment questionnaires. Receives: Device: Nerivio REN device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue Medication Usage
Proportion of treatments in which patients did not use additional prescribed medications within 2-hours following REN treatment
Measured: 2 hours
Secondary outcomes (7)
Pain Relief
Proportion of treatments in which there was a reduction in headache intensity from moderate or severe headache at baseline to mild or no pain 2 hours post-treatment.
Measured: 2 hours
Pain Freedom
Proportion of treatments in which there was a reduction in headache intensity from mild or moderate or severe headache at baseline to no headache 2 hours post-treatment.
Measured: 2 hours
Functional Disability Relief
Proportion of treatments in which there was at least one-grade improvement in functional disability level at baseline to 2 hours post-treatment.
Measured: 2 hours
Functional Disability Freedom
Proportion of treatments in which there was a reduction in functional disability level at baseline to no functional disability at 2 hours post-treatment.
Measured: 2 hours
Freedom from migraine-associated symptoms (Photophobia, Phonophobia, Nausea/Vomiting)
Proportion of treatments in which there was an absence of at least one of the three associated symptoms 2 hours post-treatment in treatments with reported associated symptoms at baseline.
Measured: 2 hours
Treatment intensity
Average treatment intensity across all treatments per patient and cohort
Measured: 45 minutes
Device Safety
Rate of serious adverse events, adverse events, and device-related adverse events
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start9 Jan 2026
- Primary completion25 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open label, single arm, real-world-evidence (RWE) study
- Masking
- None (open label)
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alit Stark-Inbar, PhD, Principal investigator, Theranica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336420
- Sponsor's protocol ID
- RWE-014
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Brooks-Horrar KN, Crisan E, Mama E, Stark-Inbar A, Ironi A, Towne AR, Sico JJ. U.S. Veterans Using Remote Electrical Neuromodulation for Migraine: A Prospective Real-World Evidence Study of Treatment Patterns, Medication Use, Effectiveness, and Safety (2020-2025). Mil Med. 2026 Jul 28:usag341. doi: 10.1093/milmed/usag341. Online ahead of print.
PubMed 42520312
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns, Medication Usage, Effectiveness, and Safety Among US Veterans Using the Remote Electrical Neuromodulation (REN) Wearable Device for Migraine Treatment
- ClinicalTrials.gov ID
- NCT07336420
- Acronym / sponsor ID
- RWE-014
- Conditions
- Migraine, Acute Treatment of Migraine
- Keywords
- Nerivio, Remote Electrical Neuromodulation, Acute Treatment of Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 13 Jan 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.
Among US veterans, migraine is a prevalent and disabling neurological disorder, creating a clinical need for effective treatment options.
This real-world evidence (RWE) study assessed the use, effectiveness, and safety of the REN wearable for the acute treatment of migraine among veterans, with a primary focus on whether they need rescue medications following REN treatment. Findings from this study may help guide clinical decision-making as veterans and providers craft treatment plans that include non-pharmacologic options.
Detailed description
Migraine is a highly prevalent and disabling neurological disorder characterized by recurrent headache attacks often accompanied by nausea, sensitivity to light or sound, and functional impairment. Affecting approximately 14% of the global population, migraine substantially reduces quality of life and interferes with daily functioning.
Within the veteran affairs (VA) population in the United States, headache disorders including migraine, are particularly common, and their diagnosis has increased throughout the years. In this population, headache disorders commonly develop following service-related injuries or exposures, such as service eras and traumatic brain injury (TBI), contributing their prevalence and severity. Moreover, veterans with headache disorders frequently present with multiple comorbidities, including post-traumatic stress disorder (PTSD), depression, anxiety, sleep disorders, chronic musculoskeletal pain, neck and back disorders, and TBI-related symptoms. This complex clinical profile increases disability, complicates treatment decisions, and can limit the use of certain pharmacologic therapies due to contraindications or polypharmacy.
Despite the availability of multiple therapeutic options, many patients face challenges in managing their migraine due to limited drug tolerability, contraindications, or medication-overuse headache (MOH). These challenges are particularly pronounced among veterans where comorbid conditions and polypharmacy often complicate or restrict pharmacological therapeutic options highlighting the need for effective, well-tolerated, non-pharmacological alternatives. Demonstrating effective pain, functional impairment, and symptom freedom or relief, with minimal reliance on additional medications, is particularly relevant in this population. This need is supported by the adoption of non-pharmacological treatment options by the Veterans Health Administration (VHA).
Remote electrical neuromodulation (REN) is a prescribed wearable device for non-invasive, non-pharmacological treatment of migraine, indicated for acute and/or preventive treatment in patients aged 8 years and older. Many studies, including randomized controlled trials and real-world evidence studies, have shown the efficacy and safety of the REN wearable device in treating migraine pain and associated symptoms.
This real-world evidence (RWE) study assessed the use, effectiveness, and safety of the REN wearable for the acute treatments of migraine among veterans, with a primary focus on whether they need rescue medications following REN treatment, as well as on treatment effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open label, single arm, real-world-evidence (RWE) study
| Arm | Type | Receives |
|---|---|---|
| Nerivio treatment | Active comparator | Device: Nerivio REN deviceVA patients who were prescribed the REN wearable device and had at least 2 treatments with reports on baseline and 2-hours post-treatment questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- VA patients who were prescribed the Nerivio REN device
- Performed at least 2 REN treatments with both baseline and 2-hours reports
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Nerivio REN deviceRemote electrical neuromodulation (REN) wearable device for the acute treatment of migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application. | Device | Nerivio treatment |
Primary outcome
Rescue Medication Usage
Time frame: 2 hours
Proportion of treatments in which patients did not use additional prescribed medications within 2-hours following REN treatment
7 secondary outcomes
Pain Relief
Time frame: 2 hours
Pain Freedom
Time frame: 2 hours
Functional Disability Relief
Time frame: 2 hours
Functional Disability Freedom
Time frame: 2 hours
Freedom from migraine-associated symptoms (Photophobia, Phonophobia, Nausea/Vomiting)
Time frame: 2 hours
Treatment intensity
Time frame: 45 minutes
Device Safety
Time frame: up to 5 years
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 3 Apr 2026.
- Derived from this study: PubMed 42520312Brooks-Horrar KN, Crisan E, Mama E, Stark-Inbar A, Ironi A, Towne AR, Sico JJ. U.S. Veterans Using Remote Electrical Neuromodulation for Migraine: A Prospective Real-World Evidence Study of Treatment Patterns, Medication Use, Effectiveness, and Safety (2020-2025). Mil Med. 2026 Jul 28:usag341. doi: 10.1093/milmed/usag341. Online ahead of print.
- 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.
Alit Stark-Inbar, PhD principal investigator
Theranica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nerivio REN device in people with Migraine and Acute Treatment of Migraine, run by Theranica 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 2 inclusion and 1 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 3 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rescue Medication Usage (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07336420, which also lists 1 linked publication.
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 3 Apr 2026.