Actively Recruiting
Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction
Led by Nanchang University Affiliated Rehabilitation Hospital · Updated on 2025-10-07
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of binaural synchronous vagus nerve regulation to treat patients who have sensory and motor dysfunction following a cerebral infarction (stroke). This randomized controlled clinical trial aims to provide strong evidence on this treatment approach by comparing it to a sham stimulation. The study includes patients who have experienced their first ischemic stroke within 7 to 14 days and are between 18 and 80 years old. Participants are randomly assigned to one of two groups: the experimental group receives true synchronous vagus nerve stimulation on both ears, while the control group receives sham stimulation with a device that looks and feels similar but provides no therapeutic effect. Treatments last 30 minutes per session, once daily, five days a week, over four weeks. The device used is the JY-VNS-200, and care is taken to keep the study double-blinded so that neither patients nor evaluators know the group assignments. During the study, participants undergo various assessments before treatment, at the end of treatment, and three months after stroke onset. These include motor and sensory function scores, overall functional assessments, and brain activity measurements using Transcranial Magnetic Stimulation combined with Electroencephalography (TMS-EEG). Cognitive function is also evaluated before treatment begins. Safety is monitored throughout, and the total participation duration covers initial treatment and follow-up evaluations to observe lasting effects.
CONDITIONS
Brief Title
Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with first-episode ischemic stroke within 7 to 14 days of onset
- Age 18 to 80 years old
- Skin at the stimulation area must be intact
- Signed informed consent form
You will not qualify if you...
- Severe cognitive dysfunction (Mini-Mental State Examination score less than 19)
- Peripheral limb movement limitations such as fractures
- History of major neurological or mental disorders
- Uncontrollable limb or facial muscle twitching and spontaneous profuse sweating
- Presence of intracranial shunt pumps or metal implants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive daily 30-minute sessions of binaural vagus nerve stimulation or sham stimulation in a supine position, 5 days per week for 4 weeks.
20 visits (in-person, daily sessions 5 days per week)
Duration - Approximately 2 months after treatment
Participants are assessed for motor, sensory, overall functional, and cognitive functions after treatment and at 3 months post-onset.
2 visits (in-person assessments before end of treatment and at 3 months post-onset)
Trial Site Locations
Total: 1 location
1
The Fourth Affiliated Rehabilitation Hospital of Nanchang University
Nanchang, Jiangxi, China, 330009
Actively Recruiting
Research Team
H
Han Jinjing Attending Physician
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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