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Enrolling by Invitation

NCT Number: NCT06687460

Distal Nerve Electrical Stimulation for Neuromuscular Reinnervation

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.

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Key information

Conditions

Electrical Stimulation Peripheral Nerve Regeneration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, Taiwan, 704302

Who can participate

Healthy volunteers accepted: No

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

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:
  • Evidence of muscle atrophy (including thenar muscles, hypothenar muscles, and interosseous muscles)
  • Positive Froment's sign
  • Positive Wartenberg's sign
  • Presence of ape hand deformity
  • Abnormal findings on electromyography (Needle EMG), such as abnormal insertional activity, increased spontaneous activity, or abnormal motor unit recruitment
  • 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

Treatment and study plan

Brief electrical stimulation

Other

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

no nerve electrical stimulation

Other

only nerve microsurgical reconstruction, no nerve electrical stimulation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. MMDT

    Time frame: Preoperative (applicable to subjects with nerve compression), the third and sixth months after surgery

    Assessment of hand dexterity and posture tolerance

  5. 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 13, 2024
Registry last updated
Apr 15, 2026

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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