Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06023953 |
| Other study ID # |
RWE006 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
August 1, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Theranica |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is a Post-marketing study investigating the safety and efficacy of the acute treatment
of migraine with a Remote Electrical Neuromodulation (REN) device (Nerivio) in migraine
patients with and without aura, as well as characterizing demographic and attack
characteristic differences between migraine patients with and without aura.
Safety will be assessed by the number and type of device-related adverse events. Efficacy
will be evaluated as a change in headache pain severity from baseline to 2 hours
post-treatment. Disease characteristics will look into demographic and attack differences
between patients with and without aura.
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 smartphone application 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 specify 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 the
presence or absence of aura, pain level (none, mild, moderate, severe), functional disability
(none, mild limitation, moderate limitation, severe limitation), presence of associated
symptoms (photophobia, phonophobia, and nausea), 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 and efficacy of REN in larger
and more diverse populations than in clinical trials 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
in patients with and without aura by analyzing data from patients who used the Nerivio
device. The following outcomes will be assessed:
1. - Safety - all adverse events that were reported during the study's period
2. - Efficacy - pain relief, freedom from pain, improvement in functional disability, and
return to normal function (no disability) at 2 hours post-treatment 3 - Disease severity
-severe headache pain, presence of associated symptoms.
Together, these objectives provide a comprehensive evaluation of the effect of REN as a
treatment for migraine with or without aura.
