Distal Nerve Electrical Stimulation for Neuromuscular Reinnervation

NCT ID: NCT06687460

Last Updated: 2024-12-02

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-12

Study Completion Date

2026-12-31

Brief Summary

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During the process of nerve microsurgical reconstruction, 30 minutes of electrical stimulation is applied to the distal end of the damaged nerve to assess its potential benefits for nerve regeneration, functional recovery, slowing down the degeneration at the neuromuscular junction, and preventing muscle atrophy.

Detailed Description

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Conditions

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Electrical Stimulation Peripheral Nerve Regeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nerve electrical stimulation

During the process of nerve microsurgical reconstruction, a 30-minute electric stimulation is applied to the distal end of the damaged nerve.

Group Type EXPERIMENTAL

Brief electrical stimulation

Intervention Type OTHER

During the nerve micro-reconstruction surgery, electrical stimulation is given to the distal end of the damaged nerve for 30 minutes.

nerve microsurgical reconstruction

no nerve electrical stimulation

Group Type PLACEBO_COMPARATOR

no nerve electrical stimulation

Intervention Type OTHER

only nerve microsurgical reconstruction, no nerve electrical stimulation

Interventions

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Brief electrical stimulation

During the nerve micro-reconstruction surgery, electrical stimulation is given to the distal end of the damaged nerve for 30 minutes.

Intervention Type OTHER

no nerve electrical stimulation

only nerve microsurgical reconstruction, no nerve electrical stimulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 and older
* Acute peripheral nerve rupture between the elbow and wrist
* Acute rupture of the median or ulnar nerve
* Patients who have signed a valid written consent for surgery and trials

Exclusion Criteria

* History of injury or other causes leading to muscle and joint dysfunction in the affected area
* Patients with radial nerve damage
* Diabetes
* History of arrhythmia
* Stroke
* Multiple sclerosis
* Hereditary peripheral neuropathy
* Amyotrophic lateral sclerosis (ALS)
* Patients with a pacemaker
* Presence of local infection at the wound site
* Pregnant or breastfeeding women
* Patients deemed unsuitable for enrollment by a physician
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cheng Kung University Hospital

Tainan City, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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A-BR-112-085

Identifier Type: -

Identifier Source: org_study_id