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

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 Overview

• Status: Not yet recruiting
• Conditions: Post-Stroke Cognitive Impairment
• Intervention / Treatment: Procedure: True Electroacupuncture; Procedure: Sham Electroacupuncture

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lusha Tong, MD; Phone Number: 086+15868171218; Email: 2310040@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: True Electroacupuncture	Procedure: True 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.
Sham Comparator: Sham Electroacupuncture	Procedure: Sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	baseline, 3 months and 6 months post-treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	baseline, 3 months, and 6 months
MRI Examination	MRI scans are used to comprehensively assess the impact of electroacupuncture on brain structure and function.	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.	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.	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.	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: The Third Affiliated hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 14, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Post-Stroke Cognitive Impairment; Acupoint Regulation; Brain Electric Field Therapy
• Other Study ID Numbers: 2025-1384

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No