Electrical StimulationNCT06687460
Distal Nerve Electrical Stimulation for Neuromuscular Reinnervation
A study testing Brief electrical stimulation and no nerve electrical stimulation in people with Electrical Stimulation and Peripheral Nerve Regeneration, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electrical Stimulation, Peripheral Nerve Regeneration
- What is being tested?
- Brief electrical stimulation and no nerve electrical stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Brief electrical stimulation, no nerve electrical stimulation
- Keywords
- electrical stimulation, peripheral nerve regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief electrical stimulationOther
During the nerve micro-reconstruction surgery, electrical stimulation is given to the distal end of the damaged nerve for 30 minutes.
no nerve electrical stimulationOther
only nerve microsurgical reconstruction, no nerve electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Brief electrical stimulation |
| nerve microsurgical reconstruction | Placebo comparator | no nerve electrical stimulation Receives: Other: no nerve electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The third month after surgery.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Preoperative (applicable to subjects with nerve compression), the third and sixth months after surgery.
MMDT
Assessment of hand dexterity and posture tolerance
Measured: 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.
Measured: Preoperative (applicable to subjects with nerve compression) and the sixth month after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start12 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrical StimulationStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687460
- Sponsor's protocol ID
- A-BR-112-085
- Status last verified
- Apr 2026
- First submitted
- 5 Nov 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Electrical Stimulation for Promoting Peripheral Nerve Regeneration After Primary Neurorrhaphy of Upper Extremities
- ClinicalTrials.gov ID
- NCT06687460
- Acronym / sponsor ID
- A-BR-112-085
- Keywords
- electrical stimulation, peripheral nerve regeneration
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nerve electrical stimulation | Experimental | Other: Brief electrical stimulationDuring the process of nerve microsurgical reconstruction, a 30-minute electric stimulation is applied to the distal end of the damaged nerve. |
| nerve microsurgical reconstruction | Placebo comparator | Other: no nerve electrical stimulationno nerve electrical stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief electrical stimulationDuring the nerve micro-reconstruction surgery, electrical stimulation is given to the distal end of the damaged nerve for 30 minutes. | Other | nerve electrical stimulation |
| no nerve electrical stimulationonly nerve microsurgical reconstruction, no nerve electrical stimulation | Other | nerve microsurgical reconstruction |
Primary outcome
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.
5 secondary outcomes
DASH questionnaire
Time frame: 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.
Purdue Pegboard test
Time frame: 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
NCV/EMG(CMAP,latency)
Time frame: Preoperative (applicable to subjects with nerve compression) and the sixth month after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief electrical stimulation and no nerve electrical stimulation in people with Electrical Stimulation and Peripheral Nerve Regeneration, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NCV/EMG(CMAP,latency) (time frame: The third month after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.