Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
The Fourth Affiliated Rehabilitation Hospital of Nanchang University
RECRUITING
Nanchang
Contact Information
Primary
Han Jinjing Attending Physician
515476321@qq.com
13672202061
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 40
Treatments
No_intervention: Sham Stimulation Group
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.
Experimental: transcutaneous auriculai vagus nerve stimulation
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.
Related Therapeutic Areas
Sponsors
Leads: Nanchang University Affiliated Rehabilitation Hospital