Real-world Data Analysis of REN Treatment in Migraine Patients

November 19, 2024 updated by: Theranica

Real-world Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine

Data analysis concerning four sets of metrics: A. Per-treatment patterns of REN use as a standalone treatment vs. in combination with medications. B. Per-user Intra-individual consistency of efficacy across multiple treatments (consistency defined as a response to treatment in at least 50% of treatments). C. Distribution of treatment intensity among users (the electroceutical equivalent to treatment dose). D. Prevalence and severity of adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The REN device The REN device is a wearable device applied to the upper arm and 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 can be adjusted by the patient.

Data collection 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 of their own free will, and that their de-identified data may be used for research purposes. Users were 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 indication of which medications, if any, were taken within that 2-hour time window.

Dataset Real-world data of REN treatments collected from patients across the United States who used the REN device.

'Treatment' defined as a REN treatment of at least 20 minutes (the nominal duration is 45 minutes).

'Evaluable treatment' defined as a treatment in which pain levels were reported at baseline and post 2 hours.

Inclusion criteria for each of the different metrics:

A. REN-medication combinations: all evaluable treatments. B. Consistent efficacy: all users that performed at least 2 evaluable treatments. In order to isolate the effect of REN treatments, this dataset considered only treatments where REN was used as a standalone treatment.

C. Intensity stability: all treatments. D. Safety: all reported adverse events (AEs) within the time period.

Outcome measures

Respectively, outcome measures:

A. REN-Medication combinations (prevalence & efficacy):

Medication intake outcomes calculated based on the 2h post-treatment report and comprised of the percentage of treatments in which no rescue medications were used, treatments in which OTC medications were taken, treatments in which triptans were taken, treatments in which other prescription medications were taken, and treatments in which medication intake status was not reported. OTC included acetaminophen, NSAIDs, and combinations of the two, with or without caffeine.

Efficacy outcomes calculated based on the baseline and post-2h reports and comprised of:

(i) consistency of pain relief (decrease in headache from moderate or severe at baseline to mild or no pain); (ii) consistency of pain-freedom (decrease in headache from mild, moderate, or severe at baseline to no pain); (iii) Consistency of improvement in function (improvement in at least one grade between baseline and 2 hours); and (iv) consistency of return to normal function (no functional disability at 2 hours).

B. Consistent efficacy:

Consistency defined as a response of a patient to the treatment in at least 50% of their treated attacks, and calculated for the four efficacy outcomes: (i) consistency of pain relief (ii) consistency of pain-freedom (iii) consistency of improvement in function; and (iv) consistency of return to normal function.

C. Treatment intensity:

The mean intensity of the stimulation collected for all treatments that were 20 minutes or longer, which were performed within the study's time window.

D. Safety:

All adverse events that were reported within the study's period, the following information provided: number of device-related AEs, percentage of the device-related AEs that were mild, moderate, and severe, and percentage of AEs that were serious vs. not serious.

Study Type

Observational

Enrollment (Actual)

12151

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Netanya, Israel
        • Theranica Bio-Electronics
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Theranica USA Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

REN users across the United States who used Nerivio between October 1st, 2019, and May 24th, 2021.

Description

Inclusion Criteria:

REN users in the U.S.

Exclusion Criteria:

Cohort 1 REN treatments that were shorter than 20 minutes or did not have a report of pain level.

Cohort 2 Treatments in which medications were taken within 2 hours from REN treatment. Users that had less than 2 REN treatments.

Cohort 3 REN treatments that were shorter than 20 minutes

Cohort 4 All REN sessions, regardless of duration or medication intake.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
REN-Medication combinations

all evaluable treatments.

'Treatment' defined as a REN treatment of at least 20 minutes (the nominal duration is 45 minutes).

'Evaluable treatment' defined as a treatment in which pain levels were reported at baseline and post 2 hours.
Device: Remote Electrical Neuromodulation (REN)
Acute migraine treament
Other Names:
  • Nerivio
Consistent efficacy

all users that performed at least 2 evaluable treatments. In order to isolate the effect of REN treatments, this dataset considered only treatments where REN was used as a standalone treatment.

'Treatment' defined as a REN treatment of at least 20 minutes (the nominal duration is 45 minutes).

'Evaluable treatment' defined as a treatment in which pain levels were reported at baseline and post 2 hours.
Device: Remote Electrical Neuromodulation (REN)
Acute migraine treament
Other Names:
  • Nerivio
Treatment intensity distribution

all treatments.

'Treatment' defined as a REN treatment of at least 20 minutes (the nominal duration is 45 minutes).
Device: Remote Electrical Neuromodulation (REN)
Acute migraine treament
Other Names:
  • Nerivio
Safety
all reported treatment/device-related adverse events (AEs) within the time period.
Device: Remote Electrical Neuromodulation (REN)
Acute migraine treament
Other Names:
  • Nerivio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
REN-medication combinations- prevalence
Time Frame: 2 hours from treatment onset
Medication intake outcomes calculated based on the 2h post-treatment report and comprised of the percentage of treatments in which no rescue medications were used, treatments in which OTC medications were taken, treatments in which triptans were taken, treatments in which other prescription medications were taken, and treatments in which medication intake status was not reported. OTC included acetaminophen, NSAIDs, and combinations of the two, with or without caffeine.
2 hours from treatment onset
REN-medication combinations- efficacy of the combinations
Time Frame: 2 hours from treatment onset
The efficacy of treatments in which medications were taken will be calculated based on the 2 hours post-treatment pain report. The overall efficacy rate will be calculated as the percentage of treatments in which response to the treatment was achieved, out of all the treatments.
2 hours from treatment onset
percentage of users that achieve consistency of efficacy
Time Frame: 2 hours from treatment onset
Consistency defined as a response of a patient to the treatment in at least 50% of their treated attacks, and calculated for the four efficacy outcomes: (i) consistency of pain relief (ii) consistency of pain-freedom (iii) consistency of improvement in function; and (iv) consistency of return to normal function.
2 hours from treatment onset
Treatment intensity distribution
Time Frame: 20 minutes from treatment onset
The mean intensity of the stimulation collected for all treatments that were 20 minutes or longer, which were performed within the study's time window.
20 minutes from treatment onset
Safety (number of users reporting device/treatment-related adverse events)
Time Frame: 20 months
The percentage of users reporting adverse events, out of the overall number of users, and the severity of the treatment/device-related adverse events.
20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theranica

Collaborators

Mayo Clinic
Georgetown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

August 7, 2021

Study Completion (Actual)

August 10, 2021

Study Registration Dates

First Submitted

July 4, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RW002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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