Real-World Evidence (RWE) Data Analysis of 1-year Consecutive Use of Remote Electrical Neuromodulation (REN)

Migraine Clinical Trial

Official title:

Real-World Evidence (RWE) Data Analysis of 1-year Safety, Consistent Utilization, and Consistent Efficacy of Remote Electrical Neuromodulation (REN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05760638
• Other study ID #: RWE004
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: April 2, 2023

Study information

• Verified date: February 2023
• Source: Theranica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: April 2, 2023
• Est. primary completion date: March 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• Nerivio
Remote electrical neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application

Locations

Country	Name	City	State
Israel	Theranica Bio-Electronics Ltd	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Theranica

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Related Adverse Events	Incidence of device-related adverse events reported by subjects	12 months
Secondary	Long Term Utilization of Nerivio	consistency of monthly usage of Nerivio device during 12 months period	12 months
Secondary	Consistent Headache Relief at 2 Hours Post-treatment	The proportion of subjects reporting headache relief at 2 hours post-treatment in at least 50% of all their treatments. Headache relief is defined as an improvement from severe or moderate pain to mild or no pain.; Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)	2 hours
Secondary	Consistent Freedom From Headache at 2 Hours Post-treatment	The proportion of subjects reporting freedom from headache at 2 hours post-treatment in at least 50% of all their treatments. Pain freedom is defined as the disappearance of headache from severe, moderate, or mild headache at treatment initiation to no headache 2 hours later; Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)	2 hours
Secondary	Consistent Functional Disability Relief at 2 Hours Post-treatment	The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported improvement of at least one level of Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.; Functional Disability level is reported using a 4-point Likert scale (0-No limitation, 1-Some limitation, 2-Moderate limitation, 3-Severe limitation)	2 hours
Secondary	Consistent Functional Disability disappearance at 2 Hours Post-treatment	The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported no Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.; Functional Disability level is reported using a 4-point Likert scale (0-No limitation, 1-Some limitation, 2-Moderate limitation, 3-Severe limitation)	2 hours