Post-Stroke Cognitive Impairment
Conditions
Keywords
Post-Stroke Cognitive Impairment, Acupoint Regulation, Brain Electric Field Therapy
Brief summary
This clinical study investigates whether electroacupuncture can improve thinking and memory in people with cognitive problems after a stroke (Post-Stroke Cognitive Impairment, or PSCI). Participants will be randomly assigned to one of two groups: one group will receive real electroacupuncture, while the other will receive a sham treatment . Both groups will also receive standard medical care.The main goal is to see if the real electroacupuncture leads to greater improvement in cognitive function tests over 6 months compared to the sham treatment. The study will also use brain scans (MRI) and other assessments to understand how the treatment might work.
Interventions
PROCEDURETrue Electroacupuncture
The true electroacupuncture group will receive electroacupuncture treatment for 7 days, once a day, each session lasting approximately 30 minutes. Acupoints include main points (e.g., bilateral forehead lines, Tianzhu BL10, Fengchi GB20) and syndrome-based points. After needle insertion and manual stimulation for deqi, true EA (100 Hz dense wave, tolerable intensity) is applied the SDZ-IIB device, connecting MS2 and BL10 on each side.
PROCEDURESham Electroacupuncture
The sham electroacupuncture group will receive electroacupuncture treatment for 7 days, once a day, each session lasting approximately 30 minutes.The same acupoints and needle insertion/manual stimulation are used. However, a modified SDZ-IIB device with severed leads (incapable of current output) is connected, simulating the appearance of true electroacupuncture without electrical stimulation. The treatment frequency and duration are identical to the electroacupuncture group.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
The Third Affiliated hospital of Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Meets diagnostic criteria for Vascular Cognitive Impairment (VCI) per the 2024 Chinese VCI guidelines. 2. Meets TCM diagnostic criteria per the 2024 Vascular Mild Cognitive Impairment guidelines. 3. Cognitive scores: MMSE 12-24 and MoCA \<24; NIHSS ≤8; AD-8 \<2. 4. Age 35-80 years. 5. Basic communication ability (Mandarin) and has a stable caregiver. 6. Provides written informed consent.
Exclusion criteria
1. Severe chronic systemic diseases (e.g., cardiac, hepatic, renal, hematologic) or unstable cardiovascular/cerebrovascular disease. 2. Local skin conditions (e.g., herpes, ulceration, keloid) contraindicating acupuncture. 3. Contraindications for repeated MRI (e.g., claustrophobia, post-aneurysm embolization). 4. Pre-existing cognitive impairment or other major uncontrolled neurological/psychiatric disorders. 5. Deemed unsuitable for the study by investigators. 6. Participation in another clinical trial within the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mini-Mental State Examination (MMSE) Score | baseline, 3 months and 6 months post-treatment. | The Mini-Mental State Examination (MMSE) is a standardized 30-point questionnaire used to screen for cognitive impairment. Total scores range from 0 to 30, with higher scores indicating better cognitive function. |
| Change in MoCA (Montreal Cognitive Assessment) Scale Score | baseline, 3 months and 6 months post-treatment. | The Montreal Cognitive Assessment (MoCA) is a 30-point screening tool designed to detect mild cognitive impairment. Total scores range from 0 to 30, with higher scores indicating better cognitive function. |
| Change in Clinical Dementia Rating (CDR) scale Score | baseline, 3 months and 6 months post-treatment. | The Clinical Dementia Rating (CDR) is a clinician-rated scale that assesses the severity of dementia across six domains. The global CDR score ranges from 0 (no impairment) to 3 (severe dementia), with higher scores indicating greater severity of dementia. |
| Change in NTB (Neuropsychological Test Battery) Score | baseline, 3 months and 6 months post-treatment. | The Neuropsychological Test Battery (NTB) is a composite measure designed to assess cognitive function across multiple domains. It evaluates key areas including memory (e.g., verbal/visual recall), attention, executive function, and processing speed. A composite Z-score is derived by averaging the standardized scores of the individual cognitive tests. The composite score is interpreted such that higher scores indicate better overall cognitive performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multimodal functional Near-Infrared Spectroscopy - Electroencephalogram (fNIRS-EEG) Assessment | baseline, 3 months, and 6 month | Functional Near-Infrared Spectroscopy (fNIRS) and Electroencephalogram (EEG) are used to non-invasively record cerebral hemodynamic changes (blood oxygen levels and blood flow) and electrophysiological brain activity, respectively, to explore neural correlates of treatment response. |
| Quality of Life as assessed by the Stroke-Specific Quality of Life Scale (SS-QOL) | baseline, 3 months, and 6 months. | The Stroke-Specific Quality of Life Scale (SS-QOL) is a patient-reported outcome measure designed to evaluate health-related quality of life specifically for stroke survivors. It assesses multiple domains relevant to life after stroke. Scores are calculated for each domain and a total score can be derived, with higher scores indicating better perceived quality of life. |
| Depressive Symptoms as assessed by the Hamilton Depression Rating Scale (HRSD-24) | baseline, 3 months, and 6 months | The Hamilton Depression Rating Scale (HRSD-24) is a clinician-administered scale used to rate the severity of depressive symptoms. Higher total scores indicate greater severity of depression. |
| Traditional Chinese Medicine (TCM) Syndrome Score | baseline, 3 months, and 6 months | A diagnostic scale based on the TCM Diagnostic and Treatment Guidelines for Vascular Mild Cognitive Impairment (2024). It evaluates TCM symptoms, tongue, and pulse features to diagnose syndrome patterns (e.g., Kidney Deficiency with Blood Stasis). A total score ≥12 confirms the diagnosis of a specific syndrome pattern. |
| MRI Examination | baseline, 3 months, and 6 months | MRI scans are used to comprehensively assess the impact of electroacupuncture on brain structure and function. |
| Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) | baseline, 3 months, and 6 months | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire assessing sleep quality and disturbances over a 1-month interval. The global score ranges from 0 to 21, with higher scores indicating worse sleep quality. |
| Independence in Activities of Daily Living as assessed by the modified Barthel Index (MBI) | Baseline, 3 months, 6 months | The modified Barthel Index (MBI) is an observer-rated scale used to measure a person's performance in basic activities of daily living (ADL), such as feeding, bathing, and mobility. The total score ranges from 0 to 100, with higher scores indicating greater independence. |
| Functional Disability as assessed by the modified Rankin Scale (mRS) | Baseline, 3 months, 6 months | The modified Rankin Scale (mRS) is a clinician-reported measure of global disability after a stroke. Scores range from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability. |
Contacts
CONTACTLusha Tong, MD
Outcome results
None listed