Clinical trial NCT05769322: Real World Data Analysis: Impact of High-Frequency REN Treatments As Migraine Preventive Therapy in Adolescence
Official title: Remote Electrical Neuromodulation (REN) Wearable Device for Adolescents with Migraine: Real World Study of High-Frequency Users Suggest Preventive Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: Migraine prevention
headache
Nerivio
REN
Lead sponsor: Theranica
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 83
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 and 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. 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.

Detailed description: The REN device (Nerivio by Theranica, ISRAEL) is a neuromodulation device approved by the FDA for acute and/or preventive treatment of migraine in patients of 12 years old and above. 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 by 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.

This post-marketing RWE study investigates the potential of high usage of Nerivio for the acute treatment of migraine on migraine prevention, using the following outcomes:

1. - reduction in mean monthly migraine treatment days (MMTD),
2. - acute treatment efficacy measured 2 h post-treatment
3. - improve in functional disability
4. - Device safety

Together, these objectives may provide a comprehensive evaluation of the impact of the high usage of Nerivio for acute treatment as a migraine preventive tool in the migraine adolescent population.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Treatments shorter than 30 minutes

Primary outcomes:
measure: Reduction in Mean Monthly Migraine Treatment Days
timeFrame: 3 months
Secondary outcomes:
measure: Consistent Headache Relief at 2 Hours Post-treatment
timeFrame: 2 hours
measure: Consistent Freedom From Headache at 2 Hours Post-treatment
timeFrame: 2 hours
measure: Consistent Functional Disability Relief at 2 Hours Post-treatment
timeFrame: 2 hours
measure: Consistent Functional Disability disappearance at 2 Hours Post-treatment
timeFrame: 2 hours
measure: Device Related Adverse Events
timeFrame: 3 months
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Theranica USA Inc
state: New Jersey
Study officials:
affiliation: Theranica Bio-Electronics Ltd
name: Alit Stark Inbar, PhD
role: PRINCIPAL_INVESTIGATOR
References: