Distal Nerve Electrical Stimulation for Neuromuscular Reinnervation

April 12, 2026 updated by: National Cheng-Kung University Hospital

Brief Electrical Stimulation for Promoting Peripheral Nerve Regeneration After Primary Neurorrhaphy of Upper Extremities

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan
      • Tainan, Taiwan, Taiwan, 704302
        • National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

  • Patients with acute transection or compression of the median nerve or ulnar nerve resulting in impaired hand motor function.Patients with hand motor dysfunction secondary to nerve compression are defined as those who meet all of the following criteria:

    1. Evidence of muscle atrophy (including thenar muscles, hypothenar muscles, and interosseous muscles)
    2. Positive Froment's sign
    3. Positive Wartenberg's sign
    4. Presence of ape hand deformity
    5. Abnormal findings on electromyography (Needle EMG), such as abnormal insertional activity, increased spontaneous activity, or abnormal motor unit recruitment
    6. Classified as Grade IIA, IIB, or III according to the McGowan classification system for severity of nerve compression

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: Brief electrical stimulation
During the nerve micro-reconstruction surgery, electrical stimulation is given to the distal end of the damaged nerve for 30 minutes.
Placebo Comparator: nerve microsurgical reconstruction
no nerve electrical stimulation
Other: no nerve electrical stimulation
only nerve microsurgical reconstruction, no nerve electrical stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NCV/EMG(CMAP,latency)
Time Frame: The third month after surgery.
The electromyography (EMG) is a diagnostic method used to assess muscle and nerve function, primarily to detect muscle activity and nerve conduction velocity, in order to monitor the recovery of neuromuscular function after surgery. During the EMG examination, the examiner uses electrodes attached to the palm to measure and record the electrophysiological signals of the muscles for further analysis. Through this method, doctors can evaluate the electrophysiological activity of the muscles to assess the reinnervation of distal muscles by the damaged nerves.
The third month after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DASH questionnaire
Time Frame: Preoperative (applicable to subjects with nerve compression), the first, third, and sixth months after surgery.
The DASH questionnaire (Disabilities of the Arm, Shoulder, and Hand) is a tool used to assess a patient's upper extremity function and symptoms. It helps in evaluating the impact of musculoskeletal disorders on daily activities and quality of life.
Preoperative (applicable to subjects with nerve compression), the first, third, and sixth months after surgery.
Muscle power
Time Frame: Preoperative (applicable to subjects with nerve compression), the third and sixth months after surgery.
Muscle power refers to the ability of a muscle or group of muscles to exert force quickly. It is a combination of strength and speed, and is often measured in activities that require explosive movements, such as sprinting, jumping, or lifting weights. Muscle power is important for athletic performance and functional movement in daily activities.
Preoperative (applicable to subjects with nerve compression), the third and sixth months after surgery.
Purdue Pegboard test
Time Frame: Preoperative (applicable to subjects with nerve compression), the third and sixth months after surgery.
The Purdue Pegboard test is a standardized assessment used to measure manual dexterity and fine motor skills. It involves placing pegs into holes on a board as quickly and accurately as possible, using one hand at a time and then both hands. The test is commonly used in occupational therapy, rehabilitation, and research to evaluate hand function and coordination.
Preoperative (applicable to subjects with nerve compression), the third and sixth months after surgery.
MMDT
Time Frame: Preoperative (applicable to subjects with nerve compression), the third and sixth months after surgery
Assessment of hand dexterity and posture tolerance
Preoperative (applicable to subjects with nerve compression), the third and sixth months after surgery
NCV/EMG(CMAP,latency)
Time Frame: Preoperative (applicable to subjects with nerve compression) and the sixth month after surgery.
Electromyography (EMG) is a diagnostic method used to assess muscle and nerve function, primarily for detecting muscle activity and nerve conduction velocity to monitor the recovery of neuromuscular function post-surgery. During an EMG examination, the examiner attaches electrodes to the palm to measure and record the electrophysiological signals of the muscles for further analysis. This allows physicians to evaluate the electrophysiological activity of the muscles and assess the reinnervation of distal muscles by the damaged nerves.
Preoperative (applicable to subjects with nerve compression) and the sixth month after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-BR-112-085

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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