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NCT Number: NCT07423715

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.

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Key information

Conditions

Post-stroke Cognitive Impairment

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Mini-Mental State Examination (MMSE) Score

    Time frame: 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.

  2. Change in MoCA (Montreal Cognitive Assessment) Scale Score

    Time frame: 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.

  3. Change in Clinical Dementia Rating (CDR) scale Score

    Time frame: 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.

  4. Change in NTB (Neuropsychological Test Battery) Score

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Traditional Chinese Medicine (TCM) Syndrome Score

    Time frame: 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.

  5. MRI Examination

    Time frame: baseline, 3 months, and 6 months

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

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lusha Tong, MD

CONTACT

[email protected]

086+15868171218

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • The Third Affiliated hospital of Zhejiang Chinese Medical University

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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