A new clinical trial, titled “Efficacy and Safety of Nerivio for the Management of Amplified Musculoskeletal Pain Syndrome in Pediatric Patients,” has been announced on ClinicalTrials.gov, with details indicating that recruitment is set to begin soon. The study focuses on evaluating the effectiveness and safety of the Nerivio® device in managing Amplified Musculoskeletal Pain Syndrome (AMPS) among pediatric populations.
What changed?
The announcement highlights that the clinical study, sponsored by Children’s Health and Theranica, has not yet started recruiting participants. The trial aims to explore the Nerivio® device—a wearable medical device—and compare it against usual care in treating AMPS. This focus offers new directions in the management of pediatric chronic pain conditions using novel technologies.
Study focus
AMPS presents significant challenges to affected patients, causing widespread physical pain. This trial assesses the Nerivio® device’s ability to safely alleviate symptoms. While traditional care methods have shown limited success in offering consistent relief, wearable devices like Nerivio® propose innovative solutions based on neuromodulation principles.
Study design and intervention
The design involves two groups: one receiving usual care and the other using the Nerivio® wearable. The device delivers controlled stimulation aimed at modulating pain perception. Researchers will gauge measures such as safety, effectiveness, and performance.
Why is amplified musculoskeletal pain syndrome important?
AMPS is a complex condition that involves heightened sensitivity to pain and impacts a growing number of pediatric cases globally. It requires evidence-supported treatment avenues, emphasizing interventions tailored to a younger population. If successful, the Nerivio® device could address gaps in existing care models, providing relief while maintaining safety standards important for pediatric patients.
Device details
Manufactured by Theranica, the Nerivio® device is currently cleared for migraine treatment through FDA pathways. Its mechanism utilizes remote electrical neuromodulation (REN) delivered through a lightweight, wearable unit. Early applications of REN have shown promise in improving pain-related outcomes in patients with non-chronic conditions.
Regulatory and clinical significance
Pending trial results are critical. If proven safe and effective, this study could provide regulatory pathways for expanded indications of the Nerivio® device and open doors for pediatric-targeted wearable device solutions.
Frequently Asked Questions
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1. What is the Nerivio® device?
The Nerivio® device is a wearable medical device leveraging remote electrical neuromodulation to modulate pain perception.
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2. Who is sponsoring the trial?
The clinical trial has joint sponsorship from Theranica, a manufacturer of the Nerivio® device, and Children’s Health.
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3. What is AMPS?
Amplified Musculoskeletal Pain Syndrome is a condition in which patients experience amplified pain responses due to disrupted pain modulation mechanisms.
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4. When will recruitment begin?
Recruitment dates have not been confirmed but are expected to begin shortly, as per the status shown on ClinicalTrials.gov.
Conclusion
The upcoming trial of the Nerivio® device represents new possibilities in pediatric pain management research. Stakeholders, including clinical, quality, and regulatory teams, should monitor developments. As wearable medical devices rise in prominence, focused investigations like this create opportunities for innovation driven by safety and performance outcomes.
Disclaimer
This content is informational and aimed at professionals handling clinical and regulatory topics. It is not legal advice.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07249931?term=medical+device