NCT06687460

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Sep 2024Dec 2027

Study Start

First participant enrolled

September 12, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

November 5, 2024

Last Update Submit

April 12, 2026

Conditions

Electrical StimulationPeripheral Nerve Regeneration

Keywords

electrical stimulationperipheral nerve regeneration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • DASH questionnaire

    Preoperative (applicable to subjects with nerve compression), the first, third, and sixth months after surgery.

  • Muscle power

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

  • Purdue Pegboard test

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

  • MMDT

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

  • NCV/EMG(CMAP,latency)

    Preoperative (applicable to subjects with nerve compression) and the sixth month after surgery.

Study Arms (2)

nerve electrical stimulation

EXPERIMENTAL

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

nerve microsurgical reconstruction

PLACEBO COMPARATOR

no nerve electrical stimulation

Other: no nerve electrical stimulation

Interventions

Brief electrical stimulationOTHER

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

nerve electrical stimulation
no nerve electrical stimulationOTHER

only nerve microsurgical reconstruction, no nerve electrical stimulation

nerve microsurgical reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan, 704302, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 13, 2024

Study Start

September 12, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

TW(1)