An observational study in Migraine, sponsored by Theranica. Completed at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Theranica · Observational
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.
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:
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 83 is below the median of 130 across 299 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Theranica is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adolescence (age 12-18) who suffers from migraine and are using the Nerivio device for acute treatment of migraine.
Exclusion Criteria:
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.
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.
Time frame: 3 months
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)
Time frame: 2 hours
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).
Time frame: 2 hours
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).
Time frame: 2 hours
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).
Time frame: 2 hours
Device Related Adverse Events
Incidence of device-related adverse events reported by subjects
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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