Cerebral InfarctionNCT07081568
Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction
A study testing transcutaneous auriculai vagus nerve stimulation in people with Cerebral Infarction, run by Nanchang University Affiliated Rehabilitation Hospital at 1 site in China.
Trial summary
The aim of this study is to determine the efficacy and safety of binaural synchronous vagus nerve regulation in the treatment of patients with sensory and motor dysfunction after cerebral infarction through a randomized controlled clinical study, and to provide high-quality evidence support for binaural synchronous… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- transcutaneous auriculai vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2025to 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with first-episode ischemic stroke within 7 to 14 days of onset;
- Be over 18 years old;
- The skin at the irritated area remains intact;
- The informed consent form has been signed.
Who cannot join
- Severe cognitive dysfunction (Mini-Mental State Examination≥19);
- Peripheral limb movement limiting factors (fractures);
- History of major neurological and mental disorders in the past;
- Uncontrollable limb and facial muscle twitching, and spontaneous profuse sweating;
- Intracranial shunt pumps, metal implants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Rehabilitation Hospital of Nanchang University
Nanchang, Jiangxi, 330009
Han Jinjing Attending Physician, 13672202061, 515476321@qq.com
About this study
The aim of this study is to determine the efficacy and safety of binaural synchronous vagus nerve regulation in the treatment of patients with sensory and motor dysfunction after cerebral infarction through a randomized controlled clinical study, and to provide high-quality evidence support for binaural synchronous vagus nerve regulation in the treatment of cerebral infarction.
Read the detailed description
The research subjects were first-onset cerebral infarction and were recruited at the Affiliated Rehabilitation Hospital of Nanchang University (the Fourth Affiliated Hospital). Based on the estimated sample size, a total of 40 patients were included in this study. The randomization grouping protocol divided 40 patients into the experimental group and the control group in a 1:1 ratio. Experimental group: Received synchronous vagus nerve regulation in both ears. Control group: Received false stimulation. The randomization procedure was carried out by independent statisticians who were not involved in the implementation and statistics of the study. The trial secretary placed the generated random numbers and groups respectively into opaque envelopes. After the patients were confirmed to be included in the group, the project leader opened the envelopes numbered in sequence to complete the grouping. This study was A double-blind design, using a unified binaural vagus nerve electrical stimulation device (JY-VNS-200, Jiangxi Jingyi Medical Technology Company Limited.). To achieve researcher blindness, the device was preset in A/B mode, with one mode being true stimulation and the other mode being false stimulation. After the experiment, unblinding was performed by personnel who were not involved in the study. During the experiment, the patients did not know whether they were receiving actual treatment or a placebo. The patients were blind. Meanwhile, the evaluators and statistical analysts were unaware of the grouping of the patients.
- Conditions
- Cerebral Infarction
- Being tested
- transcutaneous auriculai vagus nerve stimulation
- Keywords
- Ischemic Stroke, Transcutaneous Auriculai Vagus Nerve Stimulation, Rehabilitation for Cerebral Infarction, Neuromodulation
- Medical subject headings
- Cerebral Infarction, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auriculai vagus nerve stimulationDevice
During bi-ear synchronous vagus nerve stimulation, the patient was positioned in a supine position. Two stimulating electrodes were placed bilaterally in the concha cymba and concha cavum of the ears. The patient received treatment for 30 minutes per session, once daily, 5 days per week, for a total of 4 weeks. Following each treatment session, the device was disinfected with 75% alcohol.
| Study group | Role | What they receive |
|---|---|---|
| Sham Stimulation Group | No intervention | Sham Stimulation Group received sham stimulation using device B, which had identical appearance, interface parameters, and physical sensation but no therapeutic effect. Stimulation parameters were set as follows: sinusoidal waveform; pulse width of 200μs; frequency of 20Hz; current adjusted to 0mA by the investigator; single session duration of 30 minutes. After each session, the device was disinfected with 75% alcohol. Treatment was administered once daily, 5 days per week, for a total duration of 4 weeks. |
| transcutaneous auriculai vagus nerve stimulation | Experimental | The patient was positioned in a supine position. Two stimulating electrodes were placed on the bilateral concha cymba and concha cavum. Stimulation parameters were set as follows: sinusoidal waveform; pulse width of 200μs; frequency of 20Hz; initial intensity of 2mA. Each treatment session lasted 30 minutes. Treatment was administered once daily, 5 days per week, for a total duration of 4 weeks. After each treatment session, the device was disinfected with 75% alcohol. Receives: Device: transcutaneous auriculai vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function score
Motor function was evaluated using the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) .The assessment was performed three times. The minimum score for the Fugl-Meyer Assessment (FMA) is 0, and the maximum score is 226.A higher score on the FMA indicates better motor recovery/function and a lower level of motor impairment.
Measured: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease
Overall functional score
Assess three times using the National Institutes of Health Stroke Scale. The maximum score on the scale is 42, and the minimum score is 0.Higher scores denote more severe stroke symptoms.
Measured: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease
Transcranial Magnetic Stimulation combined with Electroencephalography（TMS-EEG）
Amplitude and latency of key TMS-evoked potential (TEP) components ( N100, P180, N200) recorded from specific scalp electrodes (Fz, Cz, Pz) following single-pulse TMS over the dorsolateral prefrontal cortex (DLPFC).
Measured: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease
Sensory function score
Using the Eastern Michigan Neuropathy Symptom Score Assessment sensory scale for assessment, the lowest possible score is 0 and the highest is 100. A higher score indicates that the patient's neurological symptoms are more severe and that the degree of nerve damage is more apparent.
Measured: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease
Secondary outcomes (1)
Cognitive function score
Using the Mini-Mental State Examination scale for assessment, the minimum score is 0 and the maximum score is 30. The higher the score, the better the cognitive function of the examinee, indicating a normal cognitive state.
Measured: Before the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start25 Jun 2025
- Primary completion30 Jun 2027 (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 Cerebral InfarctionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchang University Affiliated Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wentao Zeng, Nanchang University Affiliated Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081568
- Sponsor's protocol ID
- SFYLL-KY-PJ-2025-004
- Status last verified
- Oct 2025
- First submitted
- 19 Jun 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction
- ClinicalTrials.gov ID
- NCT07081568
- Acronym / sponsor ID
- SFYLL-KY-PJ-2025-004
- Conditions
- Cerebral Infarction
- Keywords
- Ischemic Stroke, Transcutaneous Auriculai Vagus Nerve Stimulation, Rehabilitation for Cerebral Infarction, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nanchang University Affiliated Rehabilitation HospitalUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jul 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.
The aim of this study is to determine the efficacy and safety of binaural synchronous vagus nerve regulation in the treatment of patients with sensory and motor dysfunction after cerebral infarction through a randomized controlled clinical study, and to provide high-quality evidence support for binaural synchronous vagus nerve regulation in the treatment of cerebral infarction.
Detailed description
The research subjects were first-onset cerebral infarction and were recruited at the Affiliated Rehabilitation Hospital of Nanchang University (the Fourth Affiliated Hospital). Based on the estimated sample size, a total of 40 patients were included in this study. The randomization grouping protocol divided 40 patients into the experimental group and the control group in a 1:1 ratio. Experimental group: Received synchronous vagus nerve regulation in both ears. Control group: Received false stimulation. The randomization procedure was carried out by independent statisticians who were not involved in the implementation and statistics of the study. The trial secretary placed the generated random numbers and groups respectively into opaque envelopes. After the patients were confirmed to be included in the group, the project leader opened the envelopes numbered in sequence to complete the grouping. This study was A double-blind design, using a unified binaural vagus nerve electrical stimulation device (JY-VNS-200, Jiangxi Jingyi Medical Technology Company Limited.). To achieve researcher blindness, the device was preset in A/B mode, with one mode being true stimulation and the other mode being false stimulation. After the experiment, unblinding was performed by personnel who were not involved in the study. During the experiment, the patients did not know whether they were receiving actual treatment or a placebo. The patients were blind. Meanwhile, the evaluators and statistical analysts were unaware of the grouping of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation Group | No intervention | –Sham Stimulation Group received sham stimulation using device B, which had identical appearance, interface parameters, and physical sensation but no therapeutic effect. Stimulation parameters were set as follows: sinusoidal waveform; pulse width of 200μs; frequency of 20Hz; current adjusted to 0mA by the investigator; single session duration of 30 minutes. After each session, the device was disinfected with 75% alcohol. Treatment was administered once daily, 5 days per week, for a total duration of 4 weeks. |
| transcutaneous auriculai vagus nerve stimulation | Experimental | Device: transcutaneous auriculai vagus nerve stimulationThe patient was positioned in a supine position. Two stimulating electrodes were placed on the bilateral concha cymba and concha cavum. Stimulation parameters were set as follows: sinusoidal waveform; pulse width of 200μs; frequency of 20Hz; initial intensity of 2mA. Each treatment session lasted 30 minutes. Treatment was administered once daily, 5 days per week, for a total duration of 4 weeks. After each treatment session, the device was disinfected with 75% alcohol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with first-episode ischemic stroke within 7 to 14 days of onset;
- Be over 18 years old;
- The skin at the irritated area remains intact;
- The informed consent form has been signed.
Key exclusion criteria (5 listed)
- Severe cognitive dysfunction (Mini-Mental State Examination≥19);
- Peripheral limb movement limiting factors (fractures);
- History of major neurological and mental disorders in the past;
- Uncontrollable limb and facial muscle twitching, and spontaneous profuse sweating;
- Intracranial shunt pumps, metal implants
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 |
|---|---|---|
| transcutaneous auriculai vagus nerve stimulationDuring bi-ear synchronous vagus nerve stimulation, the patient was positioned in a supine position. Two stimulating electrodes were placed bilaterally in the concha cymba and concha cavum of the ears. The patient received treatment for 30 minutes per session, once daily, 5 days per week, for a total of 4 weeks. Following each treatment session, the device was disinfected with 75% alcohol. | Device | transcutaneous auriculai vagus nerve stimulation |
Primary outcome
Motor function score
Time frame: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease
Motor function was evaluated using the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) .The assessment was performed three times. The minimum score for the Fugl-Meyer Assessment (FMA) is 0, and the maximum score is 226.A higher score on the FMA indicates better motor recovery/function and a lower level of motor impairment.
Overall functional score
Time frame: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease
Assess three times using the National Institutes of Health Stroke Scale. The maximum score on the scale is 42, and the minimum score is 0.Higher scores denote more severe stroke symptoms.
Transcranial Magnetic Stimulation combined with Electroencephalography（TMS-EEG）
Time frame: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease
Amplitude and latency of key TMS-evoked potential (TEP) components ( N100, P180, N200) recorded from specific scalp electrodes (Fz, Cz, Pz) following single-pulse TMS over the dorsolateral prefrontal cortex (DLPFC).
Sensory function score
Time frame: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease
Using the Eastern Michigan Neuropathy Symptom Score Assessment sensory scale for assessment, the lowest possible score is 0 and the highest is 100. A higher score indicates that the patient's neurological symptoms are more severe and that the degree of nerve damage is more apparent.
1 secondary outcome
Cognitive function score
Time frame: Before the start of treatment
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 7 Oct 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous auriculai vagus nerve stimulation in people with Cerebral Infarction, run by Nanchang University Affiliated Rehabilitation Hospital at 1 site in China.
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 4 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: looking for participants now, as of the sponsor's last update on 7 Oct 2025. 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 China. 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. 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?
Contact Han Jinjing Attending Physician (13672202061, 515476321@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor function score (time frame: Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease). The study lists 4 primary outcomes in all. 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 7 Oct 2025.