MigraineNCT06738056
Nerivio Long-term Usage in Patients With Migraine
An observational study of Migraine and Acute Treatment of Migraine, run by Theranica at 1 site in United States.
Trial summary
This is a post-marketing real-world evidence study investigates long-term treatment with the Remote Electrical Neuromodulation (REN) wearable Nerivio device over 3 consecutive years in patients with migraine. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Migraine, Acute Treatment of Migraine
- What is being tested?
- Nerivio
- Type of treatment
- Medical device
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 22 Dec 2024
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with migraine (age > 12) using the Nerivio device for the treatment of their migraine.
Who may be able to join
- - Users who began treating with the REN wearable device between December 2019 and September 2021.
- - Users who treated migraine attacks consecutively for 3 years, with at least 9 months per year
- - Users with at least one treatment recorded in each of the counted months.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Theranica Bio-Elewctronics Inc
Bridgewater, New Jersey, 08807
About this study
Official title: Real-World Evidence (RWE) Data Analysis of 3-year Usage of Nerivio, a Remote Electrical Neurostimulation (REN) Device In Patients With Migraine
This is a post-marketing real-world evidence study investigates long-term treatment with the Remote Electrical Neuromodulation (REN) wearable Nerivio device over 3 consecutive years in patients with migraine.
Read the detailed description
The REN device (Nerivio by Theranica, Israel) is a neuromodulation device approved by the FDA for acute and/or preventive treatment of migraine in patients 8 years old and above. It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers. The REN device is operated by a designated app that is downloaded to the user's phone prior first use of the Nerivio device.
As part of the sign-up process for the Nerivio app, all patients accept the terms of use which specifies that providing personal information is done on their own free will and that their de-identified data may be used for research purposes. Users are not obligated to provide personal information and could treat without providing any feedback. The app includes a secure, personal migraine diary, which enables patients to record and track their migraine and other headaches. At the beginning of each treatment, and again 2 hours after the start of treatment, patients are prompted to record their symptoms, including pain level (none, mild, moderate, severe), functional disability (none, mild limitation, moderate limitation, severe limitation), and an indication of which medications, if any, were taken within that 2-hour time window.
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment by analyzing data of patients who used the Nerivio device for consecutive 3 years: the following outcome will be assessed:
Primary endpoint:
- Lack of Tachyphylaxis - No clinically meaningful change in treatment intensity between years.
Secondary endpoints:
- Consistent effectiveness - Stable pain relief, freedom from pain, functional disability relief, return to normal function (no disability), and freedom from associated symptoms at 2 hours post-treatment relative to baseline in at least 50% of the treatments between years.
- Utilization - Stable average number of monthly Nerivio treatments per year between years.
- Safety and tolerability- Number and severity of device related adverse events.
Together, these four objectives provide a comprehensive evaluation of the long-term tolerability, safety, and efficacy of the Nerivio device using a real-world dataset.
- Conditions
- Migraine, Acute Treatment of Migraine
- Being tested
- Nerivio
- Keywords
- Nerivio, Remote Electrical Neuromodulation, Long term usage
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerivioDevice
Remote electrical neuromodulation (REN) wearable device for the treatment of migraine. The device delivers 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 users | Patients with migraine who were prescribed the REN wearable device for the treatment of their migraine and began treating between December 2019 and September 2021 Receives: Device: Nerivio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long Term Lack of Tachyphylaxis
No clinically meaningful change in treatment intensity between the years (defined as change of less than 2.5 of treatment intensity units between consecutive years).
Measured: 3 Years
Secondary outcomes (7)
Long Term Consistent Pain Relief at 2 Hours Post-treatment
Constant proportion of subjects reporting relief from headache pain at 2 hours post-treatment in at least 50% of their treatments between the years.
Pain relief is defined as an improvement from severe or moderate pain at treatment initiation to mild or no pain.
Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)
Measured: 3 Years
Long Term Consistent Pain Freedom at 2 Hours Post-treatment
Constant proportion of subjects reporting freedom from headache pain at 2 hours post-treatment in at least 50% of their treatments between the years.
Pain freedom is defined as the disappearance of pain from severe, moderate, or mild headaches at treatment initiation to no pain 2 hours later.
Measured: 3 Years
Long Term Consistent Functional Disability Relief at 2 Hours Post-treatment
Constant proportion of subjects reporting functional disability at the beginning of the treatment and reported improvement of at least one level of functional disability at 2 hours post-treatment in at least 50% of their treatments between the years.
Functional disability level is reported using a 4-point Likert scale (0-No limitation, 1-Some limitation, 2-Moderate limitation, 3-Severe limitation)
Measured: 3 Years
Long Term Consistent Functional Disability disappearance at 2 Hours Post-treatment
Constant proportion of subjects reporting functional disability at the beginning of the treatment and reported no functional disability at 2 hours post-treatment in at least 50% of their treatments between the years.
Functional disability level is reported using a 4-point Likert scale (0-No limitation, 1-Some limitation, 2-Moderate limitation, 3-Severe limitation).
Measured: 3 Years
Long Term Consistent Freedom from Associated Symptoms at 2-Hours Post-treatment
Constant proportion of subjects reporting presence of associated symptoms (photophobia, phonophobia, nausea and/or vomiting) at the beginning of the treatment and reporting freedom from associated symptoms at 2 hours post-treatment in at least 50% of their treatments between the years.
Associated symptoms are reported as present or absent
Measured: 3 years
Long Term Utilization of Nerivio
Constant average number of monthly Nerivio treatments per year between the years.
Measured: 3 Years
Device Related Adverse Events
Incidence of device-related adverse events reported by subjects
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Dec 2024
- Primary completion20 Dec 2024
- Study completion22 Dec 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738056
- Sponsor's protocol ID
- RWE-008
- Status last verified
- Apr 2025
- First submitted
- 12 Dec 2024
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Nahas SJ, Birlea M, Stark-Inbar A, Shmuely S, Mama E, Ironi A, Young WB, Rapoport AM. Three years of remote electrical neuromodulation (REN) acute treatment for migraine shows consistent effectiveness and no tachyphylaxis phenomenon. Headache. 2026 Feb;66(2):440-449. doi: 10.1111/head.15069. Epub 2025 Oct 16.
PubMed 41103025
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evidence (RWE) Data Analysis of 3-year Usage of Nerivio, a Remote Electrical Neurostimulation (REN) Device In Patients With Migraine
- ClinicalTrials.gov ID
- NCT06738056
- Acronym / sponsor ID
- RWE-008
- Conditions
- Migraine, Acute Treatment of Migraine
- Keywords
- Nerivio, Remote Electrical Neuromodulation, Long term usage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 17 Dec 2024 (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 is a post-marketing real-world evidence study investigates long-term treatment with the Remote Electrical Neuromodulation (REN) wearable Nerivio device over 3 consecutive years in patients with migraine.
Detailed description
The REN device (Nerivio by Theranica, Israel) is a neuromodulation device approved by the FDA for acute and/or preventive treatment of migraine in patients 8 years old and above. It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers. The REN device is operated by a designated app that is downloaded to the user's phone prior first use of the Nerivio device.
As part of the sign-up process for the Nerivio app, all patients accept the terms of use which specifies that providing personal information is done on their own free will and that their de-identified data may be used for research purposes. Users are not obligated to provide personal information and could treat without providing any feedback. The app includes a secure, personal migraine diary, which enables patients to record and track their migraine and other headaches. At the beginning of each treatment, and again 2 hours after the start of treatment, patients are prompted to record their symptoms, including pain level (none, mild, moderate, severe), functional disability (none, mild limitation, moderate limitation, severe limitation), and an indication of which medications, if any, were taken within that 2-hour time window.
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment by analyzing data of patients who used the Nerivio device for consecutive 3 years: the following outcome will be assessed:
Primary endpoint:
- Lack of Tachyphylaxis - No clinically meaningful change in treatment intensity between years.
Secondary endpoints:
- Consistent effectiveness - Stable pain relief, freedom from pain, functional disability relief, return to normal function (no disability), and freedom from associated symptoms at 2 hours post-treatment relative to baseline in at least 50% of the treatments between years.
- Utilization - Stable average number of monthly Nerivio treatments per year between years.
- Safety and tolerability- Number and severity of device related adverse events.
Together, these four objectives provide a comprehensive evaluation of the long-term tolerability, safety, and efficacy of the Nerivio device using a real-world dataset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerivio users | – | Device: NerivioPatients with migraine who were prescribed the REN wearable device for the treatment of their migraine and began treating between December 2019 and September 2021 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with migraine (age > 12) using the Nerivio device for the treatment of their migraine.
Key inclusion criteria (3 listed)
- - Users who began treating with the REN wearable device between December 2019 and September 2021.
- - Users who treated migraine attacks consecutively for 3 years, with at least 9 months per year
- - Users with at least one treatment recorded in each of the counted months.
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 |
|---|---|---|
| NerivioRemote electrical neuromodulation (REN) wearable device for the treatment of migraine. The device delivers 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 users |
Primary outcome
Long Term Lack of Tachyphylaxis
Time frame: 3 Years
No clinically meaningful change in treatment intensity between the years (defined as change of less than 2.5 of treatment intensity units between consecutive years).
7 secondary outcomes
Long Term Consistent Pain Relief at 2 Hours Post-treatment
Time frame: 3 Years
Long Term Consistent Pain Freedom at 2 Hours Post-treatment
Time frame: 3 Years
Long Term Consistent Functional Disability Relief at 2 Hours Post-treatment
Time frame: 3 Years
Long Term Consistent Functional Disability disappearance at 2 Hours Post-treatment
Time frame: 3 Years
Long Term Consistent Freedom from Associated Symptoms at 2-Hours Post-treatment
Time frame: 3 years
Long Term Utilization of Nerivio
Time frame: 3 Years
Device Related Adverse Events
Time frame: 3 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 17 Jul 2025.
- Derived from this study: PubMed 41103025Nahas SJ, Birlea M, Stark-Inbar A, Shmuely S, Mama E, Ironi A, Young WB, Rapoport AM. Three years of remote electrical neuromodulation (REN) acute treatment for migraine shows consistent effectiveness and no tachyphylaxis phenomenon. Headache. 2026 Feb;66(2):440-449. doi: 10.1111/head.15069. Epub 2025 Oct 16.
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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.
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?
An observational study of 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 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 17 Jul 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?
Long Term Lack of Tachyphylaxis (time frame: 3 Years). 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 NCT06738056, 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 17 Jul 2025.