Skip to main content
MedPathMedPath Home
Clinical Trials/NCT04732936
NCT04732936
Completed
Not Applicable

Feasibility Study of a Temporary Peripheral Nerve Stimulator

Epineuron Technologies Inc.3 sites in 1 country25 target enrollmentApril 1, 2021
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsNerve Injury

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nerve Injury
Sponsor
Epineuron Technologies Inc.
Enrollment
25
Locations
3
Primary Endpoint
Static Two Point Discrimination
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
June 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Are between 18-65 years old
  • •Have a Sunderland II-V peripheral nerve injury of the upper extremity
  • •Are receiving surgery within 14 days of injury

Exclusion Criteria

  • •Nerve plexus injuries (e.g. brachial plexus)
  • •Nerve gap requiring graft/conduit, or extreme joint flexion
  • •Polyneuropathies
  • •Cognitive impairment and non-English-speaking
  • •Uncontrolled diabetes
  • •Surgical intervention \> 14 days of injury
  • •Co-enrollment in another clinical trial
  • •Pregnant women

Outcomes

Primary Outcomes

Static Two Point Discrimination

Time Frame: 6 months

Measurement of spatial determination

Semmes-Weinstein Monofilament Test

Time Frame: 6 months

Measurement of pressure sensitivity

DASH Questionnaire

Time Frame: 6 months

Validated questionnaire for functionality in upper extremity injury

Patient Tolerance to Therapy Questionnaire

Time Frame: Immediately after procedure

Secondary Outcomes

  • Device Usability Questionnaire(Immediately after procedure)
  • Safety(6 months)

Study Sites (3)

Loading locations...

Similar Trials

Not yet recruiting
Not Applicable
Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps MuscleSpinal Cord InjuriesBrain InjuriesMuscle Atrophy
NCT05888714University of Sao Paulo General Hospital15
Completed
Not Applicable
Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in HomeOveractive Bladder
NCT03595215Theranova, L.L.C.18
Completed
Not Applicable
Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Postacute Sequelae of Sars-CoV-2Postacute Sequelae of Sars-CoV-2Post-Acute COVID-19 SyndromeWidespread Chronic PainFatigue Syndrome, ChronicGait, Unsteady
NCT05200858Baylor College of Medicine30
Completed
Phase 1
Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral NervesUnilateral Carpal Tunnel Syndrome
NCT00665132Bioness Inc10
Terminated
Not Applicable
Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)Chemotherapy-induced Peripheral NeuropathyPainNeuropathy
NCT06324344Baylor College of Medicine10