Feasibility Study of a Temporary Peripheral Nerve Stimulator

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-06-21

Brief Summary

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

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Detailed Description

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Conditions

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Nerve Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device Usability

Device usability and safety will be evaluated.

Group Type EXPERIMENTAL

Temporary Peripheral Nerve Stimulator

Intervention Type DEVICE

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

Preliminary Efficacy

Preliminary treatment efficacy will be evaluated.

Group Type EXPERIMENTAL

Temporary Peripheral Nerve Stimulator

Intervention Type DEVICE

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

Interventions

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Temporary Peripheral Nerve Stimulator

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No