stroke
Conditions
Interventions
Part ?: Group A:Stimulation of the left ear followed by the right ear
Part ?: Group 2:Stimulation of the right ear followed by the left ear
Part II: experimental group:Basic treatment + ta-VNS treatment
Part II: control group:Basic treatment + sham ta-VNS treatment
Part III: healthy subjects:taVNS treatment
Part III: Patient group:taVNS treatment
Sponsors
Shanghai No.3 Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
17 Years to 75 Years
Inclusion criteria
Inclusion criteria: Part I: 1. Age =18 years old and =75 years old, both sexes, right-handed; 2. No cognitive impairment was assessed by mini-mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA); 3. The 9-item Patient Health Questionnaire depression scale showed no depression; 4. Activities of daily living scale (modified barthel index) showed normal activities; 5. Agree to participate in this study and sign the informed consent form. Part II: 1. Meet the diagnostic criteria for stroke; (2) First onset, duration =1 month and =6 months, stable vital signs; 3. Age =18 years old and =75 years old, both sexes, right-handed; 4. Right-handed, primary school or above education; 5. Montreal cognitive assessment (MoCA) score > 10 and 10 and < 26; 6. Native speaker of Chinese, able to complete the test in listening and comprehension; 7. Subjects and their legal guardians (if necessary) understand and agree to participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Part I: 1. Local skin infection, ulcer or scar in the concha area; 2. Patients with serious primary or secondary diseases, such as severe liver, kidney and hematopoietic system diseases, severe cardiopulmonary dysfunction or infectious diseases; 3. have other diseases or medical history that affect cognitive function; 4. Pregnant or lactating women; 5. Addiction to drugs, alcohol or other substances; 6. Skull defects, pacemakers, cochlear implants, metal implants in the body (except stomatology), etc. Part II: 1. Local skin infection, ulcer or scar in the concha area; 2. Patients with serious primary or secondary diseases, such as severe liver, kidney and hematopoietic system diseases, severe cardiopulmonary dysfunction or infectious diseases; 3. have other diseases or medical history that affect cognitive function; 4. Pregnant or lactating women; 5. Addiction to drugs, alcohol or other substances; 6. Skull defects, pacemakers, cochlear implants, metal implants in the body (except stomatology), etc. Part III:1. Local skin infection, ulcer or scar in the concha area; 2. Patients with serious primary or secondary diseases, such as severe liver, kidney and hematopoietic system diseases, severe cardiopulmonary dysfunction or infectious diseases; 3. have other diseases or medical history that affect cognitive function; 4. Pregnant or lactating women; 5. Addiction to drugs, alcohol or other substances; 6. Skull defects, pacemakers, cochlear implants, metal implants in the body (except stomatology), etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Addenbrooke's Cognitive Examination Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montreal Cognitive Assessment Scale;Auditory Verbal learning test;digit span test;Executive interview 25(Chinese version);Shape trail making test;Dysexecutive Questionnaire;Frontal Assessment Battery;9-item Patient Health Questionnaire Depression Scale;7-item Generalized Anxiety Disorder Scale;Modified Barthel index;Functional magnetic resonance imaging;fNIRS;EEG; | — |
Countries
China
Contacts
Public ContactSongmei Chen
Shanghai No.3 Rehabilitation Hospital
Outcome results
None listed