Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation
ConditionNerve Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEpineuron Technologies Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Peripheral nerve injury
Disqualifiers
Peripheral neuropathy
Patients with any active implanted device
Trial design
Design model
Parallel
Treatments tested in this trial
Temporary Peripheral Nerve Stimulation System
DeviceSingle use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.
Sham Temporary Peripheral Nerve Stimulation System
DeviceSingle use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Active treatmentExperimental treatment 1 intervention
Group B: Sham treatmentSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sensory recovery
Time frame
6 months2
Cumulative incidence of adverse events
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov