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Not yet recruiting NCT07423715

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

No phase Interventional Post-Stroke Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: True Electroacupuncture, Sham Electroacupuncture.
Who it may be relevant to
Registry conditions: Post-Stroke Cognitive Impairment. Basic parameters: 35 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Change in Mini-Mental State Examination (MMSE) Score [Time frame: baseline, 3 months and 6 months post-treatment.]
  • Change in MoCA (Montreal Cognitive Assessment) Scale Score [Time frame: baseline, 3 months and 6 months post-treatment.]
  • Change in Clinical Dementia Rating (CDR) scale Score [Time frame: baseline, 3 months and 6 months post-treatment.]
  • Change in NTB (Neuropsychological Test Battery) Score [Time frame: baseline, 3 months and 6 months post-treatment.]
Secondary outcome measures (8)
  • Multimodal functional Near-Infrared Spectroscopy - Electroencephalogram (fNIRS-EEG) Assessment [Time frame: baseline, 3 months, and 6 month]
  • Quality of Life as assessed by the Stroke-Specific Quality of Life Scale (SS-QOL) [Time frame: baseline, 3 months, and 6 months.]
  • Depressive Symptoms as assessed by the Hamilton Depression Rating Scale (HRSD-24) [Time frame: baseline, 3 months, and 6 months]
  • Traditional Chinese Medicine (TCM) Syndrome Score [Time frame: baseline, 3 months, and 6 months]
  • MRI Examination [Time frame: baseline, 3 months, and 6 months]
  • Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) [Time frame: baseline, 3 months, and 6 months]
  • Independence in Activities of Daily Living as assessed by the modified Barthel Index (MBI) [Time frame: Baseline, 3 months, 6 months]
  • Functional Disability as assessed by the modified Rankin Scale (mRS) [Time frame: Baseline, 3 months, 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07423715 · 2025-1384

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗