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

NCT07081568 | Recruiting

• 1 other identifier: SFYLL-KY-PJ-2025-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 vagus nerve regulation in the treatment of cerebral infarction.

Conditions

Cerebral Infarction

Keywords

Ischemic Stroke; Transcutaneous Auriculai Vagus Nerve Stimulation; Rehabilitation for Cerebral Infarction; Neuromodulation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  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

  Before the start of treatment

Study Arms (2)

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.

Device: transcutaneous auriculai vagus nerve stimulation

Interventions

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.

transcutaneous auriculai vagus nerve stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanchang University Affiliated Rehabilitation Hospital: lead

Study Sites (1)

The Fourth Affiliated Rehabilitation Hospital of Nanchang University

Nanchang, Jiangxi, 330009, China

RECRUITING

MeSH Terms

Conditions

Cerebral Infarction; Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Han Jinjing Attending Physician

CONTACT

13672202061; 515476321@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 23, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)