Migraine With AuraNCT06023953
Migraine With and Without Aura Characteristics and Response to Remote Electrical Neuromodulation (REN) Treatment
An observational study of Migraine With Aura and Migraine Without Aura, run by Theranica at 1 site in Israel.
Trial summary
This is a Post-marketing, real-world evidence study investigating the safety and efficacy of the acute treatment of migraine with a Remote Electrical Neuromodulation (REN) device (Nerivio) in migraine patients with and without aura, as well as characterizing demographic and attack characteristic differences between… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Migraine With Aura, Migraine Without Aura
- What is being tested?
- Nerivio device
- Type of treatment
- Medical device
- How many people
- 31,715 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2023to 1 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were diagnosed with migraine by their HCP and were prescribed Nerivio for treatment of acute migraine
Who may be able to join
- Users aged 8 years old and above
- Users who treated their migraine attacks with the Nerivio device at least twice
- Users who prospectively reported the presence of aura in at least two treatment reports (reporting at least twice having aura) , OR:
- Users who prospectively reported the absence of aura in all of their reports, with at least two reports
Who cannot join
- Users who prospectively reported having aura only once
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Migraine With and Without Aura in a Large Cohort: Characteristics and Response to Remote Electrical Neuromodulation (REN) Treatment
This is a Post-marketing, real-world evidence study investigating the safety and efficacy of the acute treatment of migraine with a Remote Electrical Neuromodulation (REN) device (Nerivio) in migraine patients with and without aura, as well as characterizing demographic and attack characteristic differences between migraine patients with and without aura.
Safety will be assessed by the number and type of device-related adverse events. Efficacy will be evaluated as a change in headache pain severity from baseline to 2 hours post-treatment. Disease characteristics will look into demographic and attack differences between patients with and without aura.
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.
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 secured, personal migraine diary, which enables patients to record and track their migraines 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.
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment in patients with and without aura by analyzing data from patients who used the Nerivio device. The following outcomes will be assessed:
- Migraine clinical characteristics - Headache pain severity, functional disability and presence of associated symptoms at treatment baseline.
- Consistent efficacy - 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.
- Safety - Rate of serious adverse events, and device-related adverse events in the study's period.
Together, these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine with or without aura.
- Conditions
- Migraine With Aura, Migraine Without Aura
- Being tested
- Nerivio device
- Keywords
- Migraine, Aura, REN, Nerivio
- Medical subject headings
- Migraine with Aura, Migraine without Aura, Migraine Disorders, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerivio deviceDevice
REN treatment with Nerivio device
| Study group | Role | What they receive |
|---|---|---|
| Migraine with aura (MWA) | Patients with migraine who treated their migraine attack with the Nerivio device at least twice and reported having aura in at least two treatment reports Receives: Device: Nerivio device | |
| Migraine without aura (MWoA ) | Patients with migraine who treated their migraine attack with the Nerivio device at least twice and reported the absence of aura in all of their reports, with at least two reports Receives: Device: Nerivio device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of consistent Headache Relief at 2 Hours Post-treatment between the MWA and MWoA groups
The difference between the MWA and MWoA groups in 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: 2 hours
Comparison of Headache Severity at treatment baseline (T=0h) between the MWA and MWoA groups
The difference between the MWA and MWoA groups in the proportion of subjects reporting severe/moderate headache pain in at least 50% of their attacks.
Measured: 0 hours (at baseline)
Secondary outcomes (7)
Comparison of consistent Pain Freedom at 2 Hours Post-treatment between the MWA and MWoA groups
The difference between the MWA and MWoA groups in the proportion of subjects reporting pain freedom at 2 hours post-treatment in at least 50% of all their treatments. Pain freedom is defined as the disappearance of pain from severe, moderate, or mild at treatment initiation to no pain 2 hours later.
Measured: 2 hours
Comparison of Functional Disability at treatment baseline (T=0h) between the MWA and MWoA groups
The difference between the MWA and MWoA groups in the proportion of subjects reporting severe/moderate disability in at least 50% of their attacks.
Measured: 0 hours (at baseline)
Comparison of Photophobia, Phonophobia and Nausea/vomiting presence at treatment baseline (T=0h) between the MWA and MWoA groups
The difference between the MWA and MWoA groups in the proportion of subjects reporting presence of a specific symptom in at least 50% of their attacks.
Measured: 0 hours (at baseline)
Comparison of Consistent Functional Disability Relief at 2 Hours Post-treatment between the MWA and MWoA groups
The difference between the MWA and MWoA groups in the proportion of subjects reporting functional disability relief at 2 hours post-treatment in at least 50% of all their treatments. Functional disability relief is defined as an improvement of at least one grade from severe, moderate or mild disability from treatment initiation to 2 hours later.
Measured: 2 hours
Comparison of Consistent Functional Disability Freedom at 2 Hours Post-treatment between the MWA and MWoA groups
The difference between the MWA and MWoA groups in the proportion of subjects reporting functional disability freedom at 2 hours post-treatment in at least 50% of all their treatments. Functional disability freedom is defined as the disappearance of disability from severe, moderate, or mild disability at treatment initiation to no disability 2 hours later.
Measured: 2 hours
Comparison of Associated Symptoms Freedom at 2 Hours Post-treatment between the MWA and MWoA groups
The proportion of subjects reporting freedom from each of the migraine-associated symptoms (photophobia, phonophobia, nausea) in at least 50% of their treatments. Associated symptoms freedom is defined as reporting presence of a symptom at treatment initiation and reporting its absence 2 hours later.
Measured: 2 hours
Device Related Adverse Events
Rate of serious adverse events, and device-related adverse events reported by subjects.
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Jul 2023
- Primary completion30 Sep 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With AuraStudies 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
- 31,715 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 Bio-Electronics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023953
- Sponsor's protocol ID
- RWE006
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2023
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Migraine With and Without Aura in a Large Cohort: Characteristics and Response to Remote Electrical Neuromodulation (REN) Treatment
- ClinicalTrials.gov ID
- NCT06023953
- Acronym / sponsor ID
- RWE006
- Conditions
- Migraine With Aura, Migraine Without Aura
- Keywords
- Migraine, Aura, REN, Nerivio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31,715 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 5 Sep 2023 (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 investigating the safety and efficacy of the acute treatment of migraine with a Remote Electrical Neuromodulation (REN) device (Nerivio) in migraine patients with and without aura, as well as characterizing demographic and attack characteristic differences between migraine patients with and without aura.
Safety will be assessed by the number and type of device-related adverse events. Efficacy will be evaluated as a change in headache pain severity from baseline to 2 hours post-treatment. Disease characteristics will look into demographic and attack differences between patients with and without aura.
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.
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 secured, personal migraine diary, which enables patients to record and track their migraines 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.
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment in patients with and without aura by analyzing data from patients who used the Nerivio device. The following outcomes will be assessed:
- Migraine clinical characteristics - Headache pain severity, functional disability and presence of associated symptoms at treatment baseline.
- Consistent efficacy - 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.
- Safety - Rate of serious adverse events, and device-related adverse events in the study's period.
Together, these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine with or without aura.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraine with aura (MWA) | – | Device: Nerivio devicePatients with migraine who treated their migraine attack with the Nerivio device at least twice and reported having aura in at least two treatment reports |
| Migraine without aura (MWoA ) | – | Device: Nerivio devicePatients with migraine who treated their migraine attack with the Nerivio device at least twice and reported the absence of aura in all of their reports, with at least two reports |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were diagnosed with migraine by their HCP and were prescribed Nerivio for treatment of acute migraine
Key inclusion criteria (4 listed)
- Users aged 8 years old and above
- Users who treated their migraine attacks with the Nerivio device at least twice
- Users who prospectively reported the presence of aura in at least two treatment reports (reporting at least twice having aura) , OR:
- Users who prospectively reported the absence of aura in all of their reports, with at least two reports
Key exclusion criteria (1 listed)
- Users who prospectively reported having aura only once
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 deviceREN treatment with Nerivio device | Device | Migraine with aura (MWA), Migraine without aura (MWoA ) |
Primary outcome
Comparison of consistent Headache Relief at 2 Hours Post-treatment between the MWA and MWoA groups
Time frame: 2 hours
The difference between the MWA and MWoA groups in 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.
Comparison of Headache Severity at treatment baseline (T=0h) between the MWA and MWoA groups
Time frame: 0 hours (at baseline)
The difference between the MWA and MWoA groups in the proportion of subjects reporting severe/moderate headache pain in at least 50% of their attacks.
7 secondary outcomes
Comparison of consistent Pain Freedom at 2 Hours Post-treatment between the MWA and MWoA groups
Time frame: 2 hours
Comparison of Functional Disability at treatment baseline (T=0h) between the MWA and MWoA groups
Time frame: 0 hours (at baseline)
Comparison of Photophobia, Phonophobia and Nausea/vomiting presence at treatment baseline (T=0h) between the MWA and MWoA groups
Time frame: 0 hours (at baseline)
Comparison of Consistent Functional Disability Relief at 2 Hours Post-treatment between the MWA and MWoA groups
Time frame: 2 hours
Comparison of Consistent Functional Disability Freedom at 2 Hours Post-treatment between the MWA and MWoA groups
Time frame: 2 hours
Comparison of Associated Symptoms Freedom at 2 Hours Post-treatment between the MWA and MWoA groups
Time frame: 2 hours
Device Related Adverse Events
Time frame: up to 30 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 15 Aug 2025.
- 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 Bio-Electronics Ltd
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 With Aura and Migraine Without Aura, run by Theranica at 1 site in Israel.
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 4 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 Aug 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 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?
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?
Comparison of consistent Headache Relief at 2 Hours Post-treatment between the MWA and MWoA groups (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 Aug 2025.