Post-Stroke Cognitive ImpairmentNCT07423715
Key Technical Research on the Treatment of Post-stroke Cognitive Impairment With Brain Electric Field Therapy Based on Acupoint Regulation
A study testing True Electroacupuncture in people with Post-Stroke Cognitive Impairment, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Post-Stroke Cognitive Impairment
- What is being tested?
- True Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- True Electroacupuncture, Sham Electroacupuncture
- Keywords
- Post-Stroke Cognitive Impairment, Acupoint Regulation, Brain Electric Field Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True ElectroacupunctureProcedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| True Electroacupuncture | Experimental | Not described Receives: Procedure: True Electroacupuncture |
| Sham Electroacupuncture | Sham comparator | Not described Receives: Procedure: Sham Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 3 months and 6 months post-treatment.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 3 months, and 6 months
MRI Examination
MRI scans are used to comprehensively assess the impact of electroacupuncture on brain structure and function.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Stroke Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423715
- Sponsor's protocol ID
- 2025-1384
- Status last verified
- Nov 2025
- First submitted
- 9 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Technical Research on the Treatment of Post-stroke Cognitive Impairment With Brain Electric Field Therapy Based on Acupoint Regulation
- ClinicalTrials.gov ID
- NCT07423715
- Acronym / sponsor ID
- 2025-1384
- Conditions
- Post-Stroke Cognitive Impairment
- Keywords
- Post-Stroke Cognitive Impairment, Acupoint Regulation, Brain Electric Field Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True Electroacupuncture | Experimental | Procedure: True Electroacupuncture |
| Sham Electroacupuncture | Sham comparator | Procedure: Sham Electroacupuncture |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True ElectroacupunctureThe 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 or surgery | True Electroacupuncture |
| Sham ElectroacupunctureThe 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. | Procedure or surgery | Sham Electroacupuncture |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Related trials for Post-Stroke Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
OPTIMAL Motor Learning in Table Tennis: A fNIRS Study
Motor Learning, Aging
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing True Electroacupuncture in people with Post-Stroke Cognitive Impairment, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lusha Tong, MD (086+15868171218, 2310040@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mini-Mental State Examination (MMSE) Score (time frame: baseline, 3 months and 6 months post-treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.