Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcutaneous auriculai vagus nerve stimulation.
- Who it may be relevant to
- Registry conditions: Cerebral Infarction. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device transcutaneous auriculai vagus nerve stimulation
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 outcome measures
- 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]
- 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]
- 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]
- 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]
Secondary outcome measures (1)
- Cognitive function score [Time frame: Before the start of treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Fourth Affiliated Rehabilitation Hospital of Nanchang University — Nanchang
Identifiers
NCT: NCT07081568 · SFYLL-KY-PJ-2025-004