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

NCT07423715 | Not Yet Recruiting DMC

• 1 other identifier: 2025-1384
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post-Stroke Cognitive Impairment

Keywords

Post-Stroke Cognitive Impairment; Acupoint Regulation; Brain Electric Field Therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

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

  baseline, 3 months, and 6 month

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

  baseline, 3 months, and 6 months.

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

  baseline, 3 months, and 6 months

• Traditional Chinese Medicine (TCM) Syndrome Score

  baseline, 3 months, and 6 months

• MRI Examination

  baseline, 3 months, and 6 months

Study Arms (2)

True Electroacupuncture

EXPERIMENTAL

Procedure: True Electroacupuncture

Sham Electroacupuncture

SHAM COMPARATOR

Procedure: Sham Electroacupuncture

Interventions

True Electroacupuncture PROCEDURE

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.

True Electroacupuncture

Sham Electroacupuncture PROCEDURE

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.

Sham Electroacupuncture

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets diagnostic criteria for Vascular Cognitive Impairment (VCI) per the 2024 Chinese VCI guidelines.
• Meets TCM diagnostic criteria per the 2024 Vascular Mild Cognitive Impairment guidelines.
• Cognitive scores: MMSE 12-24 and MoCA \<24; NIHSS ≤8; AD-8 \<2.
• Age 35-80 years.
• Basic communication ability (Mandarin) and has a stable caregiver.
• Provides written informed consent.

You may not qualify if:

• Severe chronic systemic diseases (e.g., cardiac, hepatic, renal, hematologic) or unstable cardiovascular/cerebrovascular disease.
• Local skin conditions (e.g., herpes, ulceration, keloid) contraindicating acupuncture.
• Contraindications for repeated MRI (e.g., claustrophobia, post-aneurysm embolization).
• Pre-existing cognitive impairment or other major uncontrolled neurological/psychiatric disorders.
• Deemed unsuitable for the study by investigators.
• Participation in another clinical trial within the past 3 months.

Sponsors & Collaborators

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

Central Study Contacts

Lusha Tong, MD

CONTACT

086+15868171218; 2310040@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 20, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 20, 2026

Record last verified: 2025-11