MigraineNCT07487701
Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence Study
A study testing Nerivio REN device in people with Migraine, run by Theranica at 1 site in United States.
Trial summary
Preventive pharmacologic therapies for migraine aim to reduce attack frequency and duration and improve quality of life; however, their use, overall benefit and adherence are often limited. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- 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
- 332 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2026to 15 Apr 2026
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with migraine
- Prescribed with a Nerivio REN device
- Treat with nerivio in a preventive -like manner over 3 consecutive months from sign up.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
United States1 site
Theranica Bio-Electronics Inc
Bridgewater, New Jersey, 08807
About this study
Preventive pharmacologic therapies for migraine aim to reduce attack frequency and duration and improve quality of life; however, their use, overall benefit and adherence are often limited. Remote electrical neuromodulation (REN) is a non-invasive FDA-cleared wearable device for acute and/or preventive migraine treatment. This study will evaluate the real-world efficacy and patient-reported outcomes of preventive REN use over 3 months in migraine patients.
Read the detailed description
Preventive treatment options for migraine aim to reduce attack frequency, severity, and duration, as well as the overall burden of disease, with the goal of improving patients' quality of life. The 2021 AHS Consensus Statement reports that preventive treatments are used by only 3%-13% of patients with migraine, despite the potential benefits for almost 40% of this population. Existing pharmacological treatments include several classes, such as beta-adrenergic blockers, calcium channel blockers, antiepileptic agents, tricyclic antidepressants, and therapies targeting the calcitonin gene-related peptide (CGRP) pathway, including monoclonal antibodies and small-molecule antagonists. Different studies have demonstrated that these agents can reduce monthly migraine days (MMDs) and migraine-related disability. However, their clinical use is often limited due to adverse effects, reduced effectiveness, contraindications, high cost, and poor long-term adherence, resulting in high discontinuation rates in real-world practice. These limitations highlight the need for effective, well-tolerated, and adherence-friendly preventive treatment alternatives.
Remote electrical neuromodulation (REN) is an FDA-cleared, non-invasive, non-pharmacologic prescribed wearable device indicated for the acute and/or preventive treatment of migraine in individuals aged 8 years and older. For acute treatment, REN is indicated for administration as early as possible at the onset of an attack to relieve pain and associated migraine symptoms. For preventive use, REN is indicated for treatment every other day to reduce migraine attack frequency.
The efficacy of REN for acute treatment of migraine attacks has been demonstrated in randomized controlled trials (RCTs), open-label studies, and many real-world evidence (RWE) studies. The efficacy of migraine prevention with the REN wearable has been also shown in an RCT. Preventive benefits were also shown in adolescents with high reduction in MMDs after 3 months of REN use. This study is the first to evaluate real-world preventive use of the REN wearable device in patients with migraine, assessing multiple efficacy and patient-reported outcomes following 3 months of treatment, in accordance with International Headache Society (IHS) guidelines.
- Conditions
- Migraine
- Being tested
- Nerivio REN device
- Keywords
- REN, Nerivio, Migraine prevention
- 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) 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 | Nerivio users who were prescribed with the REN wearable for their routine migraine care and treated in a prevention-like manner over 3 consecutive months Receives: Device: Nerivio REN device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average number of monthly migraine days (MMD)
Change in average number of monthly migraine days (MMD) from baseline to 3-months follow-up questionnaire.
Measured: 3 months
Secondary outcomes (3)
Patients clinical improvement
Proportion of patients reporting improvement on PGIC scale at 3-months follow-up questionnaire.
Measured: 3 months
Change in migraine attack duration
Change in average migraine attack duration from baseline to 3-months follow-up questionnaire.
Measured: 3 months
Device Safety
Rate of serious adverse events, adverse events and device-related adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start20 Feb 2026
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment Open label, single arm, Real-World-Evidence (RWE) study
- Masking
- None (open label)
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alit Stark Inbar, Principal investigator, Theranica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487701
- Sponsor's protocol ID
- RWE-012
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 1 Jul 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence Study
- ClinicalTrials.gov ID
- NCT07487701
- Acronym / sponsor ID
- RWE-012
- Conditions
- Migraine
- Keywords
- REN, Nerivio, Migraine prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 23 Mar 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.
Preventive pharmacologic therapies for migraine aim to reduce attack frequency and duration and improve quality of life; however, their use, overall benefit and adherence are often limited. Remote electrical neuromodulation (REN) is a non-invasive FDA-cleared wearable device for acute and/or preventive migraine treatment. This study will evaluate the real-world efficacy and patient-reported outcomes of preventive REN use over 3 months in migraine patients.
Detailed description
Preventive treatment options for migraine aim to reduce attack frequency, severity, and duration, as well as the overall burden of disease, with the goal of improving patients' quality of life. The 2021 AHS Consensus Statement reports that preventive treatments are used by only 3%-13% of patients with migraine, despite the potential benefits for almost 40% of this population. Existing pharmacological treatments include several classes, such as beta-adrenergic blockers, calcium channel blockers, antiepileptic agents, tricyclic antidepressants, and therapies targeting the calcitonin gene-related peptide (CGRP) pathway, including monoclonal antibodies and small-molecule antagonists. Different studies have demonstrated that these agents can reduce monthly migraine days (MMDs) and migraine-related disability. However, their clinical use is often limited due to adverse effects, reduced effectiveness, contraindications, high cost, and poor long-term adherence, resulting in high discontinuation rates in real-world practice. These limitations highlight the need for effective, well-tolerated, and adherence-friendly preventive treatment alternatives.
Remote electrical neuromodulation (REN) is an FDA-cleared, non-invasive, non-pharmacologic prescribed wearable device indicated for the acute and/or preventive treatment of migraine in individuals aged 8 years and older. For acute treatment, REN is indicated for administration as early as possible at the onset of an attack to relieve pain and associated migraine symptoms. For preventive use, REN is indicated for treatment every other day to reduce migraine attack frequency.
The efficacy of REN for acute treatment of migraine attacks has been demonstrated in randomized controlled trials (RCTs), open-label studies, and many real-world evidence (RWE) studies. The efficacy of migraine prevention with the REN wearable has been also shown in an RCT. Preventive benefits were also shown in adolescents with high reduction in MMDs after 3 months of REN use. This study is the first to evaluate real-world preventive use of the REN wearable device in patients with migraine, assessing multiple efficacy and patient-reported outcomes following 3 months of treatment, in accordance with International Headache Society (IHS) guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment Open label, single arm, Real-World-Evidence (RWE) study
| Arm | Type | Receives |
|---|---|---|
| Nerivio treatment | Active comparator | Device: Nerivio REN deviceNerivio users who were prescribed with the REN wearable for their routine migraine care and treated in a prevention-like manner over 3 consecutive months |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with migraine
- Prescribed with a Nerivio REN device
- Treat with nerivio in a preventive -like manner over 3 consecutive months from sign up.
Key exclusion criteria (1 listed)
- NA
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) 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
Change in average number of monthly migraine days (MMD)
Time frame: 3 months
Change in average number of monthly migraine days (MMD) from baseline to 3-months follow-up questionnaire.
3 secondary outcomes
Patients clinical improvement
Time frame: 3 months
Change in migraine attack duration
Time frame: 3 months
Device Safety
Time frame: 3 months
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 1 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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 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 study testing Nerivio REN device in people with 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 3 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 1 Jul 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?
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?
Change in average number of monthly migraine days (MMD) (time frame: 3 months). 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 1 Jul 2026.