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

NCT05760638 | Completed FDA Device

• 1 other identifier: RWE004
• Study Type: observational
• Target: 409
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Migraine

Keywords

Migraine headache; Nerivio; REN

Outcome Measures

Primary Outcomes (1)

• Device Related Adverse Events

  Incidence of device-related adverse events reported by subjects

  12 months

Secondary Outcomes (5)

• Long Term Utilization of Nerivio

  12 months

• Consistent Headache Relief at 2 Hours Post-treatment

  2 hours

• Consistent Freedom From Headache at 2 Hours Post-treatment

  2 hours

• Consistent Functional Disability Relief at 2 Hours Post-treatment

  2 hours

• Consistent Functional Disability disappearance at 2 Hours Post-treatment

  2 hours

Interventions

Nerivio DEVICE

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

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- Treatments shorter than 30 minutes

Sponsors & Collaborators

• Theranica: lead

Study Sites (2)

Theranica USA Inc

Bridgewater, New Jersey, 08807, United States

Location

Theranica Bio-Electronics Ltd

Netanya, Israel

Location

Related Publications (1)

• 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.

  PMID: 37855973 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alit Stark Inbar, PhD

  Theranica Bio-Electronics Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 8, 2023
• Study Start: March 1, 2023
• Primary Completion: March 26, 2023
• Study Completion: April 2, 2023
• Last Updated: November 22, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IL (1)