Distal Nerve Electrical Stimulation for Neuromuscular Reinnervation

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: Enrolling by invitation
• Conditions: Electrical Stimulation; Peripheral Nerve Regeneration
• Intervention / Treatment: Other: Brief electrical stimulation; Other: no nerve electrical stimulation

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
NCV/EMG(CMAP,latency)	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

Outcome Measure	Measure Description	Time Frame
DASH questionnaire	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	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	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	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)	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

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: electrical stimulation; peripheral nerve regeneration
• Other Study ID 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