Stroke
Conditions
Interventions
Experimental group(auricular vagus nerve electrical stimulation group):Routine rehabilitation training+Transcutaneous Auricular Vagus Nerve Stimulation
Control group (sham stimulation group):Routine rehabilitation training
Sponsors
Shaanxi Provincial Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 30 and 60 years. (2) Experience a first-ever stroke, currently in the subacute phase (1 to 6 months post-stroke). (3) Clinically stable with vital signs within normal range and conscious. (4) Present with mild to moderate disability, defined as a score of =12 on the National Institutes of Health Stroke Scale (NIHSS) and a score of 2-3 on the modified Rankin Scale (mRS). (5) Possess the basic motor function required to complete cardiopulmonary exercise testing, demonstrated by the ability to walk 10 meters independently or with minimal assistance, and have a muscle strength of >=3 on the Manual Muscle Test (MMT) in the affected lower limb. (6) Provide written informed consent signed by the patient or their legally authorized representative.
Exclusion criteria
Exclusion criteria: (1) Presence of concurrent cardiac, hepatic, or renal insufficiency; uncontrolled hypertension; severe arrhythmia; acute coronary syndrome; pulmonary disease; or active infectious disease. (2) A history of psychiatric disorders (e.g., depression or severe affective disorders). (3) Presence of skin lesions, infections, or deformities in the auricular area that would preclude the placement of taVNS electrodes. (4) Severe cognitive or communication impairments that would hinder understanding of or compliance with the study protocol. (5) Other neurological or musculoskeletal disorders that severely compromise motor function (e.g., advanced Parkinson's disease or osteoarthritis). (6) Contraindications to taVNS therapy, such as the presence of implantable electronic devices (e.g., cardiac pacemakers, deep brain stimulators). (7) Concurrent participation in another clinical trial that may interfere with the outcomes of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal Oxygen Uptake; | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate variability;NIHSS;Modified Barthel Index for Activities of Daily Living;Whole Blood Inflammatory Factors(TNF-a, IL-6, IL-1ß, IL-10, hs-CRP); | — |
Countries
China
Contacts
Public ContactXinyuan Han
Shaanxi Provincial Rehabilitation Hospital
Outcome results
None listed