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Feasibility Study of a Temporary Peripheral Nerve Stimulator

Sponsor
Epineuron Technologies Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04732936
Collaborator
(none)
25
Enrollment
3
Locations
2
Arms
17
Anticipated Duration (Months)
8.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Temporary Peripheral Nerve Stimulator
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility Study of a Temporary Peripheral Nerve Stimulator
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Device Usability

Device usability and safety will be evaluated.

Device: Temporary Peripheral Nerve Stimulator
Temporary Peripheral Nerve Stimulator to deliver 1-hr of electrical stimulation to injured nerves.
Experimental: Preliminary Efficacy

Preliminary treatment efficacy will be evaluated.

Device: Temporary Peripheral Nerve Stimulator
Temporary Peripheral Nerve Stimulator to deliver 1-hr of electrical stimulation to injured nerves.

Outcome Measures

Primary Outcome Measures

  1. Patient Tolerance to Therapy Questionnaire [Immediately after procedure]

  2. Static Two Point Discrimination [6 months]

    Measurement of spatial determination

  3. Semmes-Weinstein Monofilament Test [6 months]

    Measurement of pressure sensitivity

  4. DASH Questionnaire [6 months]

    Validated questionnaire for functionality in upper extremity injury

Secondary Outcome Measures

  1. Safety [6 months]

    As measured by the cumulative incidence of adverse events.

  2. Device Usability Questionnaire [Immediately after procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hamilton General Hospital Hamilton Ontario Canada L8L2X2
2 McMaster University Medical Centre Hamilton Ontario Canada L8N3Z5
3 St. Joseph's Healthcare Hamilton Hamilton Ontario Canada L8N4A6

Sponsors and Collaborators

  • Epineuron Technologies Inc.

Investigators

  • Principal Investigator: Christopher Coroneos, MD, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Epineuron Technologies Inc.
ClinicalTrials.gov Identifier:
NCT04732936
Other Study ID Numbers:
  • EPNR-CIP-001
First Posted:
Feb 1, 2021
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 1, 2022