Clinical trial NCT05760638: Real-World Evidence (RWE) Data Analysis of 1-year Consecutive Use of Remote Electrical Neuromodulation (REN)
Official title: Real-World Evidence (RWE) Data Analysis of 1-year Safety, Consistent Utilization, and Consistent Efficacy of Remote Electrical Neuromodulation (REN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: Migraine headache
Nerivio
REN
Lead sponsor: Theranica
Sponsor class: INDUSTRY
First posted: 2023-03-08
Enrollment: 409
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults and adolescents (age \> 12) 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 long-term safety, utilization, and efficacy of REN during 12 consecutive months of using Nerivio in migraine patients.

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 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 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 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 (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 12 months (1 year): 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 post-treatment

Together, these three objectives provide a comprehensive evaluation of long-term safety efficacy in a large real-world dataset

Eligibility criteria: Inclusion Criteria:

* Age \>12
* REN users across the United States who created Nerivio accounts on October 1st, 2019, and later.
* Had at least one Nerivio treatment per month for 12 consecutive months

Exclusion Criteria:

- Treatments shorter than 30 minutes

Primary outcomes:
measure: Device Related Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Long Term Utilization of Nerivio
timeFrame: 12 months
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
Other outcomes:
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: