Recruiting NCT05721261
Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Temporary Peripheral Nerve Stimulation System, Sham Temporary Peripheral Nerve Stimulation System.
- Who it may be relevant to
- Registry conditions: Nerve Injury. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.
Interventions
- Device Temporary Peripheral Nerve Stimulation System
Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site. - Device Sham Temporary Peripheral Nerve Stimulation System
Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.
Primary outcome measures
- Sensory recovery [Time frame: 6 months]
- Cumulative incidence of adverse events [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Peripheral nerve injury
Exclusion criteria
- Peripheral neuropathy
- Patients with any active implanted device
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 9 centers
- University of Alberta Hospital — Edmonton
- Saint John Regional Hospital — Saint John
- Hamilton General Hospital — Hamilton
- St. Joseph's Healthcare Hamilton — Hamilton
- Roth | McFarlane Hand & Upper Limb Centre — London
- Southlake Health — Newmarket
- Humber River Health — Toronto
- North York General Hospital — Toronto
- … and 1 more center
United States · 6 centers
- University of Florida Health — Gainesville
- Orlando Health Jewett Orthopedic Institute — Orlando
- Louisiana State University Health Sciences Center — New Orleans
- The Curtis National Hand Center — Baltimore
- WellSpan Health — York
- John Peter Smith Hospital — Fort Worth
Identifiers
NCT: NCT05721261 · EPNR-CIP-002