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OpenTrials
Completed

NCT Number: NCT04732936

Feasibility Study of a Temporary Peripheral Nerve Stimulator

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

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Key information

Conditions

Nerve Injury

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temporary Peripheral Nerve Stimulator

Device

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

Primary outcomes

  1. Patient Tolerance to Therapy Questionnaire

    Time frame: Immediately after procedure

  2. Static Two Point Discrimination

    Time frame: 6 months

    Measurement of spatial determination

  3. Semmes-Weinstein Monofilament Test

    Time frame: 6 months

    Measurement of pressure sensitivity

  4. DASH Questionnaire

    Time frame: 6 months

    Validated questionnaire for functionality in upper extremity injury

Secondary outcomes

  1. Safety

    Time frame: 6 months

    As measured by the cumulative incidence of adverse events.

  2. Device Usability Questionnaire

    Time frame: Immediately after procedure

Sponsors and collaborators

Lead sponsor

Epineuron Technologies Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2021
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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