Real World Data Analysis: Impact of High-Frequency REN Treatments As Migraine Preventive Therapy in Adolescence

NCT05769322 | Completed FDA Device

• 1 other identifier: RWE005
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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, suggesting potential preventive benefits.

Conditions

Migraine

Keywords

Migraine prevention; headache; Nerivio; REN

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (5)

• 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

• Device Related Adverse Events

  3 months

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

Study Population

Adolescence (age 12-18) who suffers from migraine and are using the Nerivio device for acute treatment of migraine.

You may qualify if:

• 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

You may not qualify if:

• Treatments shorter than 30 minutes

Sponsors & Collaborators

• Theranica: lead

Study Sites (1)

Theranica USA Inc

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: March 2, 2023
• First Posted: March 15, 2023
• Study Start: April 1, 2023
• Primary Completion: April 15, 2023
• Study Completion: May 1, 2023
• Last Updated: November 22, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)