Nerivio Device for Treatment of New Daily Headache Persistence (NDHP) (NCT05310227) | Clinical Trial Compass
WithdrawnNot Applicable
Nerivio Device for Treatment of New Daily Headache Persistence (NDHP)
Stopped: The device became FDA approved during enrollment thereby nullifying the need to complete the trial. No clinical data was collected.
United States0Started 2022-02-01
Plain-language summary
The goal of this study is to examine the effects of the Remote Electrical Neuromodulation (REN) device on adolescents ages 12-17 who have been diagnosed with New Daily Persistent Headache (NDPH). Pediatric patients with a diagnosis of new daily persistent headache are typically resistant to standard pharmacologic treatments and often experience systemic side effects related to medications; thus, REN offers the potential for an exciting new treatment option for patients with refractory headache disorders. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. Ultimately, the investigators hope to gain insights into the safety and efficacy of Nerivioâ„¢ for the acute treatment of NDPH in adolescents. The goal of this study is to demonstrate headache relief without unexpected device-related adverse effects
Who can participate
Age range12 Years – 17 Years
SexALL
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Inclusion criteria
✓. Participants age 12-17 years old at the time of informed consent, inclusive.
✓. Participants have at least a 6-month history of headaches that meet the diagnostic criteria for New Daily Persistent Headache (NDPH)
✓. Participants who are on stable dosing of prophylaxis agents for at least three months.
✓. Participants have personal access to a smartphone (24/7)
✓. Participants must be able and willing to comply with the protocol
✓. Parents/Guardians must be able and willing to provide written informed consent
✓. Participants must be able and willing to provide informed assent
Exclusion criteria
✕. Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
✕. Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
What they're measuring
1
Pain relief at 2 hours post-treatment
Timeframe: 2 hours post-treatment
2
Within-patient consistency
Timeframe: Before and at 1 Month after initiation of treatment with REN
3
Disappearance of associated symptoms at 2 hours post-treatment
Timeframe: 2 hours post-treatment
4
Functional disability at 2 hours post-treatment
Timeframe: 2 hours post-treatment
5
Improve of quality of life assessed by PedsMIDAS questionnaire
Timeframe: Before and at 1 Month after initiation of treatment with REN
✕. Participants who have undergone nerve block (occipital or other) in the head or neck, or treatment with onabotulinum toxin A (Botox) to the head and/or neck in the prior four months.
✕. Current participation in any other clinical interventional study
✕. Participants without basic cognitive and motor skills required for operating a smartphone.
✕. Pregnant or breastfeeding females
✕. Participants who have previous experience with the device