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Distal Nerve Electrical Stimulation for Neuromuscular Reinnervation

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06687460
Enrollment
21
Registered
2024-11-13
Start date
2024-09-12
Completion date
2027-12-31
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrical Stimulation, Peripheral Nerve Regeneration

Keywords

electrical stimulation, peripheral nerve regeneration

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.

Interventions

OTHERBrief electrical stimulation

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

OTHERno nerve electrical stimulation

only nerve microsurgical reconstruction, no nerve electrical stimulation

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
NCV/EMG(CMAP,latency)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

MeasureTime frameDescription
DASH questionnairePreoperative (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.
Muscle powerPreoperative (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.
Purdue Pegboard testPreoperative (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.
MMDTPreoperative (applicable to subjects with nerve compression), the third and sixth months after surgeryAssessment of hand dexterity and posture tolerance
NCV/EMG(CMAP,latency)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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026