MigraineNCT06138756
Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)
An observational study of Migraine, run by Theranica at 2 sites in 2 countries.
Trial summary
Migraine is a prevalent neurological disorder that severely impacts both children and adolescents, causing significant disability. Remote Electrical Neuromodulation (REN) is a nonpharmacological, prescribed, wearable device, FDA-cleared for acute and/or preventive treatment of migraine with or without aura in patients… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Migraine
- What is being tested?
- Nerivio
- Type of treatment
- Medical device
- How many people
- 293 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2023to 1 Jun 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 12 years
- All sexes
- Child
Study population: Pre-adolescents (age 6-11) who suffer from migraine and use the Nerivio device for acute treatment of migraine.
Who may be able to join
- Subject age is between 6 to 12 at the date of the REN treatment
- Subject used the Nerivio device at least once
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective, Single Arm, Open Label Post Market Study Assessing the Safety and Efficacy of Nerivio for the Treatment of Migraine in Children Under the Age of 12
Migraine is a prevalent neurological disorder that severely impacts both children and adolescents, causing significant disability. Remote Electrical Neuromodulation (REN) is a nonpharmacological, prescribed, wearable device, FDA-cleared for acute and/or preventive treatment of migraine with or without aura in patients 12 years or older. Multiple studies have shown that REN has high safety, tolerability, and efficacy in adults and adolescents. This study aims to evaluate REN's real-world safety and efficacy in pre-adolescents, 6-11 years old.
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 12 years old and above. It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers using a modulated, symmetrical, biphasic, square pulse with a pulse width of 400 μs, modulated frequency of 100-120 Hz, and up to 40 mA output current which the patient can adjust.
The REN device is operated by a designated smartphone application 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 specify 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 migraines attacks 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 the presence or absence of aura, pain level (none, mild, moderate, severe), functional disability (none, mild limitation, moderate limitation, severe limitation), presence of associated symptoms (photophobia, phonophobia, and nausea), and an indication of which medications, if any, were taken within that 2-hour time window.
Post-marketing surveillance is designed to assess the safety and efficacy of REN in larger and more diverse populations than in clinical trials and in various real-world environments and situations. As a digital therapeutic device (i.e., electroceutical), the REN device enables prospective collection of electronic patient-reported outcomes in real-world clinical practice.
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment in pre-adolescence migraine patients who used the Nerivio device. The following outcomes will be assessed:
- - Safety - Adverse events that were reported during the study's period
- - Efficacy - Pain relief, freedom from pain, improvement in functional disability, and improvement in migraine-associated symptoms following the treatment
Together, these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine in this target population.
- Conditions
- Migraine
- Being tested
- Nerivio
- Keywords
- REN, Nerivio, Children
- 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
Nerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine
| Study group | Role | What they receive |
|---|---|---|
| Pre-adolescents with migraine | Patients at the age of 6-11 (included) with migraine who were prescribed the Nerivio device by their healthcare provider and used the Nerivio device at least once Receives: Device: Nerivio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Device Related Adverse Events
Incidence of device-related adverse events reported by subjects throughout the study period
Measured: Up to 6 months
Secondary outcomes (5)
Consistent Headache Relief at 2 Hours Post-treatment
The proportion of subjects reporting headache relief at 2 hours post-treatment in at least 50% of all their treatments.
Headache relief is defined as an improvement from severe or moderate pain to mild or no pain.
Measured: up to 6 months
Consistent Freedom From Headache at 2 Hours Post-treatment
The proportion of subjects reporting freedom from headache at 2 hours post-treatment in at least 50% of all their treatments.
Pain freedom is defined as the disappearance of headache from severe, moderate, or mild headache at treatment initiation to no headache 2 hours later
Measured: up to 6 months
Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment
The proportion of subjects reporting the presence of each of the migraine-associated symptoms (nausea/vomiting, photophobia, phonophobia) at the beginning of treatment and reported their absence 2 hours following the treatment in at least 50% of their attacks.
Measured: up to 6 months
Consistent Functional Disability Relief at 2 Hours Post-treatment
The proportion of subjects who reported having 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 all their treatments.
Measured: up to 6 months
Consistent Functional Disability Disappearance at 2 Hours Post-treatment
The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported no Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Oct 2023
- Primary completion18 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 293 participants (actual)
- Target duration
- 6 Months
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
- NCT06138756
- Sponsor's protocol ID
- RWE009
- Status last verified
- Nov 2023
- First submitted
- 11 Nov 2023
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Open Label Post Market Study Assessing the Safety and Efficacy of Nerivio for the Treatment of Migraine in Children Under the Age of 12
- ClinicalTrials.gov ID
- NCT06138756
- Acronym / sponsor ID
- RWE009
- Conditions
- Migraine
- Keywords
- REN, Nerivio, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 18 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Migraine is a prevalent neurological disorder that severely impacts both children and adolescents, causing significant disability. Remote Electrical Neuromodulation (REN) is a nonpharmacological, prescribed, wearable device, FDA-cleared for acute and/or preventive treatment of migraine with or without aura in patients 12 years or older. Multiple studies have shown that REN has high safety, tolerability, and efficacy in adults and adolescents. This study aims to evaluate REN's real-world safety and efficacy in pre-adolescents, 6-11 years old.
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 12 years old and above. It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers using a modulated, symmetrical, biphasic, square pulse with a pulse width of 400 μs, modulated frequency of 100-120 Hz, and up to 40 mA output current which the patient can adjust.
The REN device is operated by a designated smartphone application 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 specify 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 migraines attacks 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 the presence or absence of aura, pain level (none, mild, moderate, severe), functional disability (none, mild limitation, moderate limitation, severe limitation), presence of associated symptoms (photophobia, phonophobia, and nausea), and an indication of which medications, if any, were taken within that 2-hour time window.
Post-marketing surveillance is designed to assess the safety and efficacy of REN in larger and more diverse populations than in clinical trials and in various real-world environments and situations. As a digital therapeutic device (i.e., electroceutical), the REN device enables prospective collection of electronic patient-reported outcomes in real-world clinical practice.
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment in pre-adolescence migraine patients who used the Nerivio device. The following outcomes will be assessed:
- - Safety - Adverse events that were reported during the study's period
- - Efficacy - Pain relief, freedom from pain, improvement in functional disability, and improvement in migraine-associated symptoms following the treatment
Together, these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine in this target population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-adolescents with migraine | – | Device: NerivioPatients at the age of 6-11 (included) with migraine who were prescribed the Nerivio device by their healthcare provider and used the Nerivio device at least once |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Pre-adolescents (age 6-11) who suffer from migraine and use the Nerivio device for acute treatment of migraine.
Key inclusion criteria (2 listed)
- Subject age is between 6 to 12 at the date of the REN treatment
- Subject used the Nerivio device at least once
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 |
|---|---|---|
| NerivioNerivio is a remote electrical neuromodulation (REN) device for the treatment of migraine | Device | Pre-adolescents with migraine |
Primary outcome
Rate of Device Related Adverse Events
Time frame: Up to 6 months
Incidence of device-related adverse events reported by subjects throughout the study period
5 secondary outcomes
Consistent Headache Relief at 2 Hours Post-treatment
Time frame: up to 6 months
Consistent Freedom From Headache at 2 Hours Post-treatment
Time frame: up to 6 months
Consistent Migraine Associated Symptoms Disappearance at 2 Hours Post-treatment
Time frame: up to 6 months
Consistent Functional Disability Relief at 2 Hours Post-treatment
Time frame: up to 6 months
Consistent Functional Disability Disappearance at 2 Hours Post-treatment
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Theranica at 2 sites in 2 countries.
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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. 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?
Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Device Related Adverse Events (time frame: Up to 6 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 15 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.