Post-Stroke Cognitive Impairment
Conditions
Interventions
Trial Group:Simultaneous scalp acupuncture combined with transcutaneous auricular vagus nerve stimulation (taVNS)
Control Group:Non-synchronized rehabilitation mode of scalp acupuncture combined with transcutaneous auricular vagus nerve stimulation (taVNS)
Sponsors
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. First-ever stroke patients meeting the above diagnostic criteria, aged 30–80 years old, with Chinese as their native language; 2. Cognitive impairment confirmed by the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), meeting either of the following criteria: (1) MoCA score 6 years of education). 3. In the recovery phase of stroke, with stable vital signs, clear consciousness, adequate comprehension ability, no severe aphasia, and able to cooperate with all assessments and treatments; 4. No use or injection of medications affecting cognitive function (e.g., donepezil, memantine, huperzine A) within 1 month prior to enrollment; 5. No visual or auditory impairment, and no strabismus; 6. Written informed consent obtained from the patient and/or their family members.
Exclusion criteria
Exclusion criteria: 1. Skin lesions, inflammation, scars, or other abnormalities at the stimulation sites for taVNS and scalp acupuncture; 2. Patients with implanted devices such as pacemakers or cochlear implants, or those with skull defects; 3. Previous vagus nerve surgery or presence of intracranial metal foreign bodies; 4. Patients with a history of acupuncture syncope or blood syncope, or with contraindications to acupuncture therapy such as hematological diseases or coagulation disorders; 5. Pre-existing significant cognitive impairment prior to stroke onset, or cognitive impairment caused by other neurodegenerative diseases (e.g., Alzheimer’s disease [AD]), demyelinating diseases, or metabolic abnormalities; 6. Use of central nervous system (CNS)-acting medications (e.g., sedative-hypnotics, antiepileptics, antipsychotics) within 1 month prior to enrollment; 7. History of epilepsy, family history of psychiatric disorders, history of drug abuse, drug dependence, or alcohol dependence; 8. Patients with severe insufficiency of vital organs (e.g., heart, liver, kidney) or malignant tumors; 9. Currently participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montreal Cognitive Assessment(MoCA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-related potentials (ERP)-P300;Mini-Mental State Examination (MMSE);Modified Barthel Index (MBI);Transcranial Doppler Ultrasonography (TCD); | — |
Countries
China
Contacts
Public ContactLiu Xihua
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed