Key Technical Research on the Treatment of Post-stroke Cognitive Impairment With Brain Electric Field Therapy Based on Acupoint Regulation

N/ANot Yet RecruitingNCT07423715

Second Affiliated Hospital, Zhejiang University, School of Medicine110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

110

Conditions

Post-Stroke Cognitive Impairment

Interventions

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.

Sham ElectroacupuncturePROCEDURE

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.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Mini-Mental State Examination (MMSE) Score

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.

Time frame: baseline, 3 months and 6 months post-treatment.

Change in MoCA (Montreal Cognitive Assessment) Scale Score

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.

Time frame: baseline, 3 months and 6 months post-treatment.

Change in Clinical Dementia Rating (CDR) scale Score

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.

Time frame: baseline, 3 months and 6 months post-treatment.

Change in NTB (Neuropsychological Test Battery) Score

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.

Time frame: baseline, 3 months and 6 months post-treatment.

Secondary Outcomes

Multimodal functional Near-Infrared Spectroscopy - Electroencephalogram (fNIRS-EEG) Assessment

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.

Time frame: baseline, 3 months, and 6 month

Quality of Life as assessed by the Stroke-Specific Quality of Life Scale (SS-QOL)

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.

Time frame: baseline, 3 months, and 6 months.

Depressive Symptoms as assessed by the Hamilton Depression Rating Scale (HRSD-24)

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.

Time frame: baseline, 3 months, and 6 months

Traditional Chinese Medicine (TCM) Syndrome Score

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.

Time frame: baseline, 3 months, and 6 months

MRI Examination

MRI scans are used to comprehensively assess the impact of electroacupuncture on brain structure and function.

Time frame: baseline, 3 months, and 6 months

Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)

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.

Time frame: baseline, 3 months, and 6 months

Independence in Activities of Daily Living as assessed by the modified Barthel Index (MBI)

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.

Time frame: Baseline, 3 months, 6 months

Functional Disability as assessed by the modified Rankin Scale (mRS)

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.

Time frame: Baseline, 3 months, 6 months

Key Technical Research on the Treatment of Post-stroke Cognitive Impairment With Brain Electric Field Therapy Based on Acupoint Regulation

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts