MigraineNCT05769322
Real World Data Analysis: Impact of High-Frequency REN Treatments As Migraine Preventive Therapy in Adolescence
An observational study of Migraine, run by Theranica at 1 site in United States.
Trial summary
This is a post-marketing study investigating the safety and efficacy of the REN device (Nerivio by Theranica, ISRAEL) in adolescents with migraine. The data analysis will test the ability of Frequent use of REN for the acute treatment of migraine to reduce the number of monthly migraine days in subsequent months… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Migraine
- What is being tested?
- Nerivio
- Type of treatment
- Medical device
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 1 May 2023
- 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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescence (age 12-18) who suffers from migraine and are using the Nerivio device for acute treatment of migraine.
Who may be able to join
- patient age is 12 Years to 18 Years
- Patient is using the Nerivio device for acute treatment of migraine
- Patient treated at least 10 treatments in his first month of using Nerivio and at least 3 treatments in each of the two consecutive months (months 2 and 3
Who cannot join
- Treatments shorter than 30 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Electrical Neuromodulation (REN) Wearable Device for Adolescents with Migraine: Real World Study of High-Frequency Users Suggest Preventive Effects
This is a post-marketing study investigating the safety and efficacy of the REN device (Nerivio by Theranica, ISRAEL) in adolescents with migraine. The data analysis will test the ability of Frequent use of REN for the acute treatment of migraine to reduce the number of monthly migraine days in subsequent months, suggesting potential preventive benefits.
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 of 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 app that is downloaded to the user's phone prior first use of the Nerivio device.
As part of the sign-up process to the Nerivio app, all patients accept the terms of use which specify that providing personal information is done by 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 pain level (none, mild, moderate, severe), functional disability (No limitation, Some 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 potential of high usage of Nerivio for the acute treatment of migraine on migraine prevention, using the following outcomes:
- - reduction in mean monthly migraine treatment days (MMTD),
- - acute treatment efficacy measured 2 h post-treatment
- - improve in functional disability
- - Device safety
Together, these objectives may provide a comprehensive evaluation of the impact of the high usage of Nerivio for acute treatment as a migraine preventive tool in the migraine adolescent population.
- Conditions
- Migraine
- Being tested
- Nerivio
- Keywords
- Migraine prevention, headache, Nerivio, REN
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerivioDevice
Remote electrical neuromodulation (REN) device for the acute treatment of migraines. 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Mean Monthly Migraine Treatment Days
Mean number of migraine treatment days per month during 3 consecutive months, comparing each month to the first month.
A migraine treatment day is defined as a day in which a patient treated their migraine with REN.
Measured: 3 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. Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)
Measured: 2 hours
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.
Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain).
Measured: 2 hours
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.
Functional Disability level is reported using a 4-point Likert scale (0 - No limitation, 1 - Some limitation, 2 - Moderate limitation, 3 - Severe limitation).
Measured: 2 hours
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.
Functional Disability level is reported using a 4-point Likert scale (0 - No limitation, 1 - Some limitation, 2 - Moderate limitation, 3 - Severe limitation).
Measured: 2 hours
Device Related Adverse Events
Incidence of device-related adverse events reported by subjects
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 posted15 Mar 2023
- Study start1 Apr 2023
- Primary completion15 Apr 2023
- Study completion1 May 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 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
- NCT05769322
- Sponsor's protocol ID
- RWE005
- Status last verified
- Feb 2023
- First submitted
- 2 Mar 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- 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 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Electrical Neuromodulation (REN) Wearable Device for Adolescents with Migraine: Real World Study of High-Frequency Users Suggest Preventive Effects
- ClinicalTrials.gov ID
- NCT05769322
- Acronym / sponsor ID
- RWE005
- Conditions
- Migraine
- Keywords
- Migraine prevention, headache, Nerivio, REN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 15 Mar 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 study investigating the safety and efficacy of the REN device (Nerivio by Theranica, ISRAEL) in adolescents with migraine. The data analysis will test the ability of Frequent use of REN for the acute treatment of migraine to reduce the number of monthly migraine days in subsequent months, suggesting potential preventive benefits.
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 of 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 app that is downloaded to the user's phone prior first use of the Nerivio device.
As part of the sign-up process to the Nerivio app, all patients accept the terms of use which specify that providing personal information is done by 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 pain level (none, mild, moderate, severe), functional disability (No limitation, Some 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 potential of high usage of Nerivio for the acute treatment of migraine on migraine prevention, using the following outcomes:
- - reduction in mean monthly migraine treatment days (MMTD),
- - acute treatment efficacy measured 2 h post-treatment
- - improve in functional disability
- - Device safety
Together, these objectives may provide a comprehensive evaluation of the impact of the high usage of Nerivio for acute treatment as a migraine preventive tool in the migraine adolescent population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescence (age 12-18) who suffers from migraine and are using the Nerivio device for acute treatment of migraine.
Key inclusion criteria (3 listed)
- patient age is 12 Years to 18 Years
- Patient is using the Nerivio device for acute treatment of migraine
- Patient treated at least 10 treatments in his first month of using Nerivio and at least 3 treatments in each of the two consecutive months (months 2 and 3
Key exclusion criteria (1 listed)
- Treatments shorter than 30 minutes
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) device for the acute treatment of migraines. 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 | – |
Primary outcome
Reduction in Mean Monthly Migraine Treatment Days
Time frame: 3 months
Mean number of migraine treatment days per month during 3 consecutive months, comparing each month to the first month. A migraine treatment day is defined as a day in which a patient treated their migraine with REN.
5 secondary outcomes
Consistent Headache Relief at 2 Hours Post-treatment
Time frame: 2 hours
Consistent Freedom From Headache at 2 Hours Post-treatment
Time frame: 2 hours
Consistent Functional Disability Relief at 2 Hours Post-treatment
Time frame: 2 hours
Consistent Functional Disability disappearance at 2 Hours Post-treatment
Time frame: 2 hours
Device Related Adverse Events
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 22 Nov 2024.
- 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, 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, 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 22 Nov 2024. 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?
Reduction in Mean Monthly Migraine Treatment Days (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 22 Nov 2024.