Real-world Data Analysis of REN Treatment in Migraine Patients

NCT04992897 | Completed FDA Device

• 1 other identifier: RW002
• Study Type: observational
• Target: 12,151
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Migraine

Keywords

Migraine; headache; REN; Nerivio

Outcome Measures

Primary Outcomes (5)

• REN-medication combinations- prevalence

  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

  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

  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

  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)

  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

Study Arms (4)

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)

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)

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)

Safety

all reported treatment/device-related adverse events (AEs) within the time period.

Device: Remote Electrical Neuromodulation (REN)

Interventions

Remote Electrical Neuromodulation (REN) DEVICE

Acute migraine treament

Also known as: Nerivio

Consistent efficacy; REN-Medication combinations; Safety; Treatment intensity distribution

Eligibility Criteria

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

Study Population

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

You may qualify if:

• REN users in the U.S.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theranica: lead
• Georgetown University: collaborator
• Mayo Clinic: collaborator

Study Sites (2)

Theranica USA Inc

Bridgewater, New Jersey, 08807, United States

Location

Theranica Bio-Electronics

Netanya, Israel

Location

Related Publications (6)

• Yarnitsky D, Dodick DW, Grosberg BM, Burstein R, Ironi A, Harris D, Lin T, Silberstein SD. Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Headache. 2019 Sep;59(8):1240-1252. doi: 10.1111/head.13551. Epub 2019 May 9.

  PMID: 31074005 BACKGROUND

• Tepper SJ, Lin T, Montal T, Ironi A, Dougherty C. Real-world Experience with Remote Electrical Neuromodulation in the Acute Treatment of Migraine. Pain Med. 2020 Dec 25;21(12):3522-3529. doi: 10.1093/pm/pnaa299.

  PMID: 32935848 BACKGROUND

• Hershey AD, Lin T, Gruper Y, Harris D, Ironi A, Berk T, Szperka CL, Berenson F. Remote electrical neuromodulation for acute treatment of migraine in adolescents. Headache. 2021 Feb;61(2):310-317. doi: 10.1111/head.14042. Epub 2020 Dec 21.

  PMID: 33349920 BACKGROUND

• Nierenburg H, Vieira JR, Lev N, Lin T, Harris D, Vizel M, Ironi A, Lewis B, Wright P. Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Patients with Chronic Migraine: An Open-Label Pilot Study. Pain Ther. 2020 Dec;9(2):531-543. doi: 10.1007/s40122-020-00185-1. Epub 2020 Jul 9.

  PMID: 32648205 BACKGROUND

• Rapoport AM, Lin T. Device profile of the Nerivio for acute migraine treatment: overview of its efficacy and safety. Expert Rev Med Devices. 2019 Dec;16(12):1017-1023. doi: 10.1080/17434440.2019.1695599. Epub 2019 Nov 25.

  PMID: 31747304 BACKGROUND

• Marmura MJ, Lin T, Harris D, Ironi A, Rosen NL. Incorporating Remote Electrical Neuromodulation (REN) Into Usual Care Reduces Acute Migraine Medication Use: An Open-Label Extension Study. Front Neurol. 2020 Apr 7;11:226. doi: 10.3389/fneur.2020.00226. eCollection 2020.

  PMID: 32318014 BACKGROUND

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 Design

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

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: August 5, 2021
• Study Start: June 15, 2021
• Primary Completion: August 7, 2021
• Study Completion: August 10, 2021
• Last Updated: November 22, 2024

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (1)