Clinical trial NCT05443659: Real-world Data Analysis of REN Treatment in Adolescence with Migraine
Official title: Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine in Adolescence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine in Adolescence
Keywords: migraine, Headache Nerivio, REN
Lead sponsor: Theranica
Sponsor class: INDUSTRY
First posted: 2022-07-05
Enrollment: 1629
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescence (age 12-18) who suffers from migraine who are using the Nerivio device for acute treatment of migraine

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. Data analysis concerning the REN treatment efficacy in terms of pain and functional disability as a standalone treatment or in combination with other medications will be performed.

Detailed description: The REN device (Nerivio by Theranica, ISRAEL) is a neuromodulation device approved by the FDA for acute treatment of migraine in patients of 12 years old and above (1-4). 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 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 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 (No limitation, Some 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 efficacy and safety 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.

Recently, Real World Evidence (RWE) papers of Nerivio usage in adults were published (5-6). these papers demonstrated the safety and efficacy of the Nerivio device in a large-scale population using the accumulated data gathered by diary within the Nerivio app.

This post-marketing RWE study investigates the efficacy of the Nerivio treatment using the following outcomes:

1. - reduction in headache pain 2h post-treatment
2. - improve in functional disability
3. - A standalone treatment vs combination with other therapies
4. - safety profile (in terms of device-related adverse events)

Together, these four objectives provide a comprehensive evaluation of efficacy, drug-device interactions, dose stability, and safety, in a large real-world dataset of over XXXXX treatments in the migraine adolescent population.

Eligibility criteria: Inclusion Criteria:

1. - Age between 12-18 years
2. - REN user across the United States who created Nerivio account on January 1st, 2021 or later.
3. - Had at least two evaluable treatments with the Nerivio device

Exclusion Criteria:

(1) - Treatments shorter than 20 minutes

Primary outcomes:
measure: Consistent Pain Relief at 2 Hours Post-treatment
timeFrame: 2 hours post treatment
Secondary outcomes:
measure: Consistent Pain Freedom at 2 Hours Post-treatment
timeFrame: 2 hours post treatment
measure: Consistent Usage of Migraine Abortive (Rescue) Medications
timeFrame: 2 hours post treatment
measure: Consistent Functional Disability Relief at 2 Hours Post-treatment
timeFrame: 2 hours post treatment
measure: Consistent Functional Disability disappearance at 2 Hours Post-treatment
timeFrame: 2 hours post treatment
Other outcomes:
measure: Treatment intensity distribution
timeFrame: 45 minutes post treatment
measure: Device Related Adverse Events
timeFrame: 16 months
Locations:
city: Bridgewater
country: United States
facility: Theranica USA Inc
state: New Jersey
city: Netanya
country: Israel
facility: Theranica Bio-Electronics Ltd
Study officials:
affiliation: Theranica Bio-Electronics ltd
name: Alit Stark Inbar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Nierenburg H, Rabany L, Lin T, Sharon R, Harris D, Ironi A, Wright P, Chuang L. Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability. Pain Ther. 2021 Dec;10(2):1245-1253. doi: 10.1007/s40122-021-00276-7. Epub 2021 Jun 17.
citation: Grosberg B, Rabany L, Lin T, Harris D, Vizel M, Ironi A, O'Carroll CP, Schim J. Safety and efficacy of remote electrical neuromodulation for the acute treatment of chronic migraine: an open-label study. Pain Rep. 2021 Oct 14;6(4):e966. doi: 10.1097/PR9.0000000000000966. eCollection 2021 Nov-Dec.
citation: 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.
citation: 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.
citation: Ailani J, Rabany L, Tamir S, Ironi A, Starling A. Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine. Front Pain Res (Lausanne). 2022 Jan 18;2:753736. doi: 10.3389/fpain.2021.753736. eCollection 2021.