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MigraineNCT05760638

Real-World Evidence (RWE) Data Analysis of 1-year Consecutive Use of Remote Electrical Neuromodulation (REN)

An observational study of Migraine, run by Theranica at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Post-marketing study investigating the long-term safety, utilization, and efficacy of REN during 12 consecutive months of using Nerivio in migraine patients. Safety will be assessed by the number and type of adverse events. Utilization will be measured by the number of monthly treatments. Read more about this study

Who is it for?
Ages 12 to 99 years
Conditions the study is for
Migraine
What is being tested?
Nerivio
Type of treatment
Medical device
How many people
409 participants
Where
2 sitesin 2 countries
Study dates
1 Mar 2023to 2 Apr 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 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Adults and adolescents (age > 12) who suffers from migraine who are using the Nerivio device for acute treatment of migraine

Who may be able to join

  • Age >12
  • REN users across the United States who created Nerivio accounts on October 1st, 2019, and later.
  • Had at least one Nerivio treatment per month for 12 consecutive months

Who cannot join

  • Treatments shorter than 30 minutes

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Theranica USA Inc

    Bridgewater, New Jersey, 08807

Other trials in United States

Israel1 site

  • Theranica Bio-Electronics Ltd

    Netanya

Other trials in Israel

About this study

Official title: Real-World Evidence (RWE) Data Analysis of 1-year Safety, Consistent Utilization, and Consistent Efficacy of Remote Electrical Neuromodulation (REN)

This is a Post-marketing study investigating the long-term safety, utilization, and efficacy of REN during 12 consecutive months of using Nerivio in migraine patients.

Safety will be assessed by the number and type of adverse events. Utilization will be measured by the number of monthly treatments. Efficacy will be evaluated as a change in headache pain severity and functional disability from baseline to 2 hours post-treatment in at least 50% of the treatments.

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 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 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 (None, Mild limitation, Moderate limitation, Severe limitation), 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, utilization, and efficacy in larger and more diverse populations 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 by analyzing data of patients who used the Nerivio device for consecutive 12 months (1 year): the following outcome will be assessed:

  1. - Safety - all adverse events that were reported within the study's period
  2. - Utilization - the number of Nerivio treatments per month
  3. - Efficacy - pain relief, freedom from pain, improvement in functional disability, and return to normal function (no disability) at 2 hours post-treatment

Together, these three objectives provide a comprehensive evaluation of long-term safety efficacy in a large real-world dataset

Conditions
Migraine
Being tested
Nerivio
Keywords
Migraine headache, Nerivio, REN
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) 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.

  1. Device Related Adverse Events

    Incidence of device-related adverse events reported by subjects

    Measured: 12 months

Secondary outcomes (5)

  1. Long Term Utilization of Nerivio

    consistency of monthly usage of Nerivio device during 12 months period

    Measured: 12 months

  2. 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

  3. 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

  4. 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

  5. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2023
  2. Study start1 Mar 2023
  3. Primary completion26 Mar 2023
  4. Study completion2 Apr 2023

Resources

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
409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05760638
Sponsor's protocol ID
RWE004
Status last verified
Feb 2023
First submitted
26 Feb 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

Publications

  • Synowiec A, Stark-Inbar A, Weinstein M, Ironi A, Mauskop A. One-Year Consistent Safety, Utilization, and Efficacy Assessment of Remote Electrical Neuromodulation (REN) for Migraine Treatment. Adv Ther. 2024 Jan;41(1):170-181. doi: 10.1007/s12325-023-02697-6. Epub 2023 Oct 19.

    PubMed 37855973

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 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 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?

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?

Device Related Adverse Events (time frame: 12 months). 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 NCT05760638, 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 22 Nov 2024.

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