Clinical trial NCT06738056: Nerivio Long-term Usage in Patients With Migraine
Official title: Real-World Evidence (RWE) Data Analysis of 3-year Usage of Nerivio, a Remote Electrical Neurostimulation (REN) Device In Patients With Migraine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Acute Treatment of Migraine
Keywords: Nerivio
Remote Electrical Neuromodulation
Long term usage
Lead sponsor: Theranica
Sponsor class: INDUSTRY
First posted: 2024-12-17
Enrollment: 244
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and adolescents (age \> 12) who suffer from migraine andare using the Nerivio device for acute treatment of migraine

Brief summary: This is a Post-marketing study investigating the long-term safety, utilization, and efficacy of Remote Electrical Neuromodulation (REN) treatments during 3 consecutive years of using Nerivio device for in patients with migraine 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.

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 8 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 for the Nerivio app, all patients accept the terms of use which specifies that providing personal information is done on 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 secure, 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 (None, Mild 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 safety, utilization, and efficacy 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. This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment by analyzing data of patients who used the Nerivio device for consecutive 3 years: the following outcome will be assessed:

1. - Safety - all adverse events that were reported within the study's period
2. - Utilization - the number of Nerivio treatments per month
3. - Efficacy - pain relief, freedom from pain, improvement in functional disability, and return to normal function (no disability) at 2 hours posttreatment Together, these three objectives provide a comprehensive evaluation of longterm safety efficacy in a large real-world dataset

Eligibility criteria: Inclusion Criteria:

1. - Users who treated migraine attacks consecutively for 3 years, with at least 9 months per year
2. - Users with at least one treatment recorded in each of the counted months during the 36 months.
3. - Users who had completed baseline and 2-hour post-treatment assessments for pain intensity and functional disability at least once in each of the counted months during the 36 months.

Exclusion Criteria:

1 - When participants reported the use of concomitant acute migraine medications during treatments, these treatments were excluded from the analysis to isolate the effects of the Nerivio device.

Primary outcomes:
measure: Device Related Adverse Events
timeFrame: 3 Years
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: Long Term Utilization of Nerivio
timeFrame: 3 years
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Theranica Bio-Elewctronics Inc
state: New Jersey
Study officials:
References: