Real World Data Analysis: Impact of High-Frequency REN Treatments as Migraine Preventive Therapy in Adolescence

Migraine Clinical Trial

Official title:

Remote Electrical Neuromodulation (REN) Wearable Device for Adolescents With Migraine: Real World Study of High-Frequency Users Suggest Preventive Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05769322
• Other study ID #: RWE005
• Status: Completed
• Start date: April 1, 2023
• Est. completion date: May 1, 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 1, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

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 BioElectronics	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Theranica

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Mean Monthly Migraine Treatment Days	Mean number of migraine treatment days per month during 3 consecutive months, comparing each month to the first month.; A migraine treatment day is defined as a day in which a patient treated their migraine with REN.	3 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
Secondary	Device Related Adverse Events	Incidence of device-related adverse events reported by subjects	3 months