Electrical Stimulation of Nerves Produces Muscle ReflexesNCT06931756
Effects of Uremia on Brachial Plexus Electrophysiology and Brachial Plexus Block
A study testing Neural Stimulator in people with Electrical Stimulation of Nerves Produces Muscle Reflexes, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
As a late stage of renal failure, uremia not only leads to severe impairment of renal function in patients, but also often leads to a variety of complications, among which multiple peripheral neuropathy is particularly common. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electrical Stimulation of Nerves Produces Muscle Reflexes
- What is being tested?
- Neural Stimulator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2025to 1 Dec 2026
- 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
- Uremia group [group U]
- Patients aged 18 years and older
- ASA classification I-IV
- BMI 18.5-29.9
- Patients with uremia planning to undergo forearm or hand surgery
- Diagnostic criteria: Patients must meet the internationally recognized diagnostic criteria for uremia and require hemodialysis
Show all 14Show fewer
- Informed consent: Patients or their legal representatives must sign an informed consent form, agreeing to participate in this study and undergo related examinations and treatments
- Non-uremia group [Group N]
- Patients aged 18 years and older
- ASA classification I-IV
- BMI 18.5-29.9
- Patients planning to undergo forearm or hand surgery
- In addition to possibly having diabetes, patients should not have any other diseases that could cause peripheral neuropathy
- The patient or their legal representative must sign an informed consent form, agreeing to participate in this study and receive the relevant examinations and treatments
Who cannot join
- Individuals allergic to study medications (such as ropivacaine)
- Those with contraindications to local anesthesia or nerve blockades, such as coagulation disorders, infections, etc.
- Those with severe cardiovascular or respiratory diseases
- Those unable to comply with study requirements, such as cognitive impairment, mental disorders, etc.
- Pregnant women
About this study
Official title: Effects of Uremia on Brachial Plexus Electrophysiology and Brachial Plexus Block: One Prospective Parallel Cohort Study
As a late stage of renal failure, uremia not only leads to severe impairment of renal function in patients, but also often leads to a variety of complications, among which multiple peripheral neuropathy is particularly common. This lesion is mainly caused by the combination of multiple mechanisms, such as the accumulation of uremic toxins, electrolyte disorder, nutrient deficiency and factors related to hemodialysis. Therefore, it is important clinical significance to deeply explore the effects of uremia on electrophysiological properties and nerve block of brachial plexus.
At present, there are relatively few studies on the effects of uremia on the brachial plexus, especially the prospective parallel cohort studies on its electrophysiological properties and nerve block. As a new anesthetic technique, ultrasound-guided axillary brachial plexus block has the advantages of precise positioning, scientific administration, reducing complications and improved safety, but the application effect and safety in uremic patients still need to be further verified.
- Being tested
- Neural Stimulator
- Keywords
- Neuron, Muscle movement, Electrical Stimulation, Electric current
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural StimulatorDevice
Adjust the neural stimulator, with a stimulation duration of 0.1 ms, a stimulation frequency of 1Hz, and a stimulation current of 1.0mA. Under ultrasound guidance, the needle tip is used to touch the radial nerve, ulnar nerve, median nerve, and musculocutaneous nerve respectively, until a clear motor response is observed in the corresponding muscles. Thereafter, the minimum stimulation threshold current is verified by reducing the current until the distal motor response disappears. If no motor response is elicited, the current intensity is appropriately increased to achieve a motor response of the extensor tendon of the radial nerve, and the flexor tendon motor responses of the ulnar nerve, median nerve, and musculocutaneous nerve.
| Study group | Role | What they receive |
|---|---|---|
| Uremia group (U group) | Experimental | 1. Patients aged 18 years and above, ASA classification I-IV, BMI 18.5-29.9, planning to undergo forearm or hand surgery.
2. Diagnostic criteria: Patients who meet the internationally recognized diagnostic criteria for uremia and require hemodialysis.
3. Informed consent: Patients or their legal representatives must sign an informed consent form, agreeing to participate in this study and undergo related examinations and treatments. Receives: Device: Neural Stimulator |
| Non-uremia group (Group N) | Experimental | 1. According to the Propensity Score Matching (PSM) design for the control group, select patients aged 18 years or older, ASA classification I to IV, matched with patients in the U group in terms of age, gender, and BMI within the corresponding group, who are planned to undergo forearm or hand surgery. In addition to possibly having diabetes, patients should not have any other diseases that could cause peripheral neuropathy.
2. Informed consent: Similar to the uremic patient group, an informed consent form must be signed. Receives: Device: Neural Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the minimum excitatory threshold current for motor electrical stimulation of the radial, ulnar, median, and musculocutaneous nerves between patients with uremia and those without uremia.
Under ultrasound guidance, using a high-frequency linear array transducer and a dedicated nerve stimulation needle, the nerves are localized in-plane technique under direct visualization. Adjust the nerve stimulator with a stimulation duration of 0.1 ms, a stimulation frequency of 1Hz, and a stimulation current of 1.0mA. Under ultrasound guidance, the needle tip is used to touch the radial nerve, ulnar nerve, median nerve, and musculocutaneous nerve respectively, until a clear motor response is observed in the corresponding muscles. Thereafter, the minimum stimulation threshold current is verified by reducing the current until the distal motor response disappears. If no motor response is elicited, the current intensity is appropriately increased to achieve motor responses of the extensor tendon of the radial nerve, and the flexor tendons of the ulnar nerve, median nerve, and musculocutaneous nerve.
Measured: one year
Secondary outcomes (4)
The onset time of forearm sensory block in two groups of patients
Testing the time for cold sensation disappearance using alcohol swabs
Measured: one year
Onset time of forearm motor block in two groups of patients
Time when forearm muscle strength drops to grade 0.
Measured: one year
The recovery time of forearm sensation in two groups of patients
Forearm tactile recovery time
Measured: one year
Recovery time for forearm movement in two groups of patients
Time for forearm muscle strength to recover to pre-surgery status
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start20 Apr 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrical Stimulation of Nerves Produces Muscle ReflexesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931756
- Sponsor's protocol ID
- KY20250123-09
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Uremia on Brachial Plexus Electrophysiology and Brachial Plexus Block: One Prospective Parallel Cohort Study
- ClinicalTrials.gov ID
- NCT06931756
- Acronym / sponsor ID
- KY20250123-09
- Keywords
- Neuron, Muscle movement, Electrical Stimulation, Electric current
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Apr 2025 (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.
As a late stage of renal failure, uremia not only leads to severe impairment of renal function in patients, but also often leads to a variety of complications, among which multiple peripheral neuropathy is particularly common. This lesion is mainly caused by the combination of multiple mechanisms, such as the accumulation of uremic toxins, electrolyte disorder, nutrient deficiency and factors related to hemodialysis. Therefore, it is important clinical significance to deeply explore the effects of uremia on electrophysiological properties and nerve block of brachial plexus.
At present, there are relatively few studies on the effects of uremia on the brachial plexus, especially the prospective parallel cohort studies on its electrophysiological properties and nerve block. As a new anesthetic technique, ultrasound-guided axillary brachial plexus block has the advantages of precise positioning, scientific administration, reducing complications and improved safety, but the application effect and safety in uremic patients still need to be further verified.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uremia group (U group) | Experimental | Device: Neural Stimulator1. Patients aged 18 years and above, ASA classification I-IV, BMI 18.5-29.9, planning to undergo forearm or hand surgery. 2. Diagnostic criteria: Patients who meet the internationally recognized diagnostic criteria for uremia and require hemodialysis. 3. Informed consent: Patients or their legal representatives must sign an informed consent form, agreeing to participate in this study and undergo related examinations and treatments. |
| Non-uremia group (Group N) | Experimental | Device: Neural Stimulator1. According to the Propensity Score Matching (PSM) design for the control group, select patients aged 18 years or older, ASA classification I to IV, matched with patients in the U group in terms of age, gender, and BMI within the corresponding group, who are planned to undergo forearm or hand surgery. In addition to possibly having diabetes, patients should not have any other diseases that could cause peripheral neuropathy. 2. Informed consent: Similar to the uremic patient group, an informed consent form must be signed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Uremia group [group U]
- Non-uremia group [Group N]
Key exclusion criteria (5 listed)
- Individuals allergic to study medications (such as ropivacaine)
- Those with contraindications to local anesthesia or nerve blockades, such as coagulation disorders, infections, etc.
- Those with severe cardiovascular or respiratory diseases
- Those unable to comply with study requirements, such as cognitive impairment, mental disorders, etc.
- Pregnant women
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 |
|---|---|---|
| Neural StimulatorAdjust the neural stimulator, with a stimulation duration of 0.1 ms, a stimulation frequency of 1Hz, and a stimulation current of 1.0mA. Under ultrasound guidance, the needle tip is used to touch the radial nerve, ulnar nerve, median nerve, and musculocutaneous nerve respectively, until a clear motor response is observed in the corresponding muscles. Thereafter, the minimum stimulation threshold current is verified by reducing the current until the distal motor response disappears. If no motor response is elicited, the current intensity is appropriately increased to achieve a motor response of the extensor tendon of the radial nerve, and the flexor tendon motor responses of the ulnar nerve, median nerve, and musculocutaneous nerve. | Device | Non-uremia group (Group N), Uremia group (U group) |
Primary outcome
The difference in the minimum excitatory threshold current for motor electrical stimulation of the radial, ulnar, median, and musculocutaneous nerves between patients with uremia and those without uremia.
Time frame: one year
Under ultrasound guidance, using a high-frequency linear array transducer and a dedicated nerve stimulation needle, the nerves are localized in-plane technique under direct visualization. Adjust the nerve stimulator with a stimulation duration of 0.1 ms, a stimulation frequency of 1Hz, and a stimulation current of 1.0mA. Under ultrasound guidance, the needle tip is used to touch the radial nerve, ulnar nerve, median nerve, and musculocutaneous nerve respectively, until a clear motor response is observed in the corresponding muscles. Thereafter, the minimum stimulation threshold current is verified by reducing the current until the distal motor response disappears. If no motor response is elicited, the current intensity is appropriately increased to achieve motor responses of the extensor tendon of the radial nerve, and the flexor tendons of the ulnar nerve, median nerve, and musculocutaneous nerve.
4 secondary outcomes
The onset time of forearm sensory block in two groups of patients
Time frame: one year
Onset time of forearm motor block in two groups of patients
Time frame: one year
The recovery time of forearm sensation in two groups of patients
Time frame: one year
Recovery time for forearm movement in two groups of patients
Time frame: one year
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 17 Apr 2025.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Stimulator in people with Electrical Stimulation of Nerves Produces Muscle Reflexes, run by Nanjing First Hospital, Nanjing Medical University.
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 14 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The difference in the minimum excitatory threshold current for motor electrical stimulation of the radial, ulnar, median, and musculocutaneous nerves between patients with uremia and those without uremia. (time frame: one year). 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 17 Apr 2025.