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NCT Number: NCT07081568

Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction

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.

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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Ischemic Stroke Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fourth Affiliated Rehabilitation Hospital of Nanchang University

Nanchang, Jiangxi, 330009, China

Location status: Recruiting

Location contact

Han Jinjing Attending Physician

CONTACT

[email protected]

13672202061

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

transcutaneous auriculai vagus nerve stimulation

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

Secondary outcomes

  1. Cognitive function score

    Time frame: Before the start of treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Han Jinjing Attending Physician

CONTACT

[email protected]

13672202061

Sponsors and collaborators

Lead sponsor

Nanchang University Affiliated Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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