Post-Stroke Cognitive Impairment (PSCI)NCT07736885
Evaluation of Clinical Efficacy and Mechanism of Hand Jing-Well Acupoint Transcutaneous Electrical Stimulation in Improving Post-Stroke Cognitive Impairment
A study testing Transcutaneous Electrical Stimulation at Jing-Well Acupoints in people with Post-Stroke Cognitive Impairment (PSCI) and Ischemic Stroke, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study evaluates a non-invasive electrical stimulation therapy applied to specific acupoints on the fingers (called Jing-Well points) to improve thinking and memory problems after stroke. Purpose: Many stroke survivors develop cognitive difficulties (problems with memory, attention, and decision-making). Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Post-Stroke Cognitive Impairment (PSCI), Ischemic Stroke, Cognitive Dysfunction, Cognitive Disorder
- What is being tested?
- Transcutaneous Electrical Stimulation at Jing-Well Acupoints
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 30 Mar 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
- Aged 35-80 years;
- Stroke duration within 2 weeks to 6 months post-onset;
- Cognitive impairment confirmed by neuropsychological assessment: Montreal Cognitive Assessment (MoCA) score < 26;
- Clinical evaluation excludes delirium, major depressive disorder, schizophrenia, or other primary psychiatric/behavioral disorders as the principal cause of current cognitive impairment. No history of other known neurological diseases that may cause cognitive impairment (e.g., multiple sclerosis, encephalitis, Parkinson's disease, post-traumatic dementia, normal pressure hydrocephalus, etc.);
- No severe aphasia; able to cooperate with scale assessments and complete the treatment protocol required by this study;
- Voluntary participation in this study; the participant or their legally authorized representative has signed the informed consent form.
Who cannot join
- Unstable vital signs or life-threatening comorbidities;
- Implanted devices (cardiac pacemaker/defibrillator, deep brain stimulator, etc.);
- History of epilepsy or epileptic seizures;
- Pregnant or lactating women;
- Concurrent use of other medications affecting cognitive function;
- Allergy to the study intervention device or history of serious adverse reactions;
- Severe arrhythmia, malignant hypertension, or severe dysfunction of vital organs (heart, liver, kidney, etc.);
- Individuals unable to participate in treatment due to severe hearing or visual impairment, or bilateral limb paralysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300073
Liang Gao, 8618722216295, Gaoliang202605@163.com
About this study
This study evaluates a non-invasive electrical stimulation therapy applied to specific acupoints on the fingers (called Jing-Well points) to improve thinking and memory problems after stroke.
Purpose: Many stroke survivors develop cognitive difficulties (problems with memory, attention, and decision-making). Current treatments are limited. This study tests whether gentle electrical stimulation to hand acupoints can improve these symptoms.
Read more
Who can participate: Adults aged [35-80] who have had an ischemic stroke and now have mild to moderate cognitive impairment.
What happens: Participants will be randomly assigned to receive either (1) active electrical stimulation to hand Jing-Well points, (2) sham (fake) stimulation. Treatment will last 4 weeks, 6 sessions per week, each 30 minutes, with a stimulation frequency of 10 Hz and intensity adjusted to each participant's tolerance. Cognitive tests and brain imaging will be done before and after treatment.
Potential benefits: Participants may experience improved cognitive function. The study will also help researchers understand how this therapy works in the brain.
Risks: The electrical stimulation may cause mild tingling or skin irritation at the electrode sites. Brain imaging is non-invasive and safe. All procedures will be performed by trained professionals.
- Conditions
- Post-Stroke Cognitive Impairment (PSCI), Ischemic Stroke, Cognitive Dysfunction, Cognitive Disorder, Hemorrhagic Strokes
- Being tested
- Transcutaneous Electrical Stimulation at Jing-Well Acupoints, Transcutaneous Sham Electrical Stimulation at Jing-Well Acupoints
- Medical subject headings
- Ischemic Stroke, Cognitive Dysfunction, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Stimulation at Jing-Well AcupointsDevice
Device-based transcutaneous electrical stimulation (TES) delivered to six hand Jing-Well acupoints: Shaoze (SI1), Shangyang (LI1), Zhongchong (PC9), Guanchong (SJ1), Shaochong (HT9), and Dadun (LR1). A custom-designed portable electrical stimulator (model YM-JX-V01, manufactured by Yimai Artificial Intelligence Medical Technology (Tianjin) Co., Ltd.) is used with disposable self-adhesive reference electrodes (4 × 4 cm) and stimulation electrodes (diameter 5 mm). Stimulation parameters: square wave, frequency 10 Hz, pulse width 320 μs, intensity individually titrated to sensory threshold (typically 0-1 mA), session duration 30 minutes. Treatment schedule: 6 sessions per week (Monday-Saturday) for 4 consecutive weeks, totaling 24 sessions. Electrodes are placed bilaterally at the designated acupoints according to WHO Standard Acupuncture Point Locations.
Transcutaneous Sham Electrical Stimulation at Jing-Well AcupointsDevice
Device-based sham transcutaneous electrical stimulation (TES) delivered to six hand Jing-Well acupoints: Shaoze (SI1), Shangyang (LI1), Zhongchong (PC9), Guanchong (SJ1), Shaochong (HT9), and Dadun (LR1). A custom-designed portable electrical stimulator with open-circuit design (model YM-JX-V01, manufactured by Yimai Artificial Intelligence Medical Technology (Tianjin) Co., Ltd.) is used with disposable self-adhesive reference electrodes (4 × 4 cm) and stimulation electrodes (diameter 5 mm). The device delivers ineffective stimulation (0 Hz, no current output) while maintaining identical visual and tactile feedback. Sessions follow the same schedule as the active group: 30 minutes per session, 6 sessions per week for 4 consecutive weeks (24 sessions total). Electrodes are placed bilaterally at the designated acupoints according to WHO Standard Acupuncture Point Locations.
| Study group | Role | What they receive |
|---|---|---|
| Active TES Group | Experimental | Participants receive transcutaneous electrical stimulation at hand Jing-Well acupoints (Shaoze SI1, Shangyang LI1, Zhongchong PC9, Guanchong SJ1, Shaochong HT9, and Dadun LR1) using a portable stimulator. Stimulation parameters: 10 Hz square wave, pulse width 320 μs, intensity adjusted to individual tolerance (typically 0-1 mA), 30 minutes per session, 6 sessions per week for 4 consecutive weeks (24 sessions total). Receives: Device: Transcutaneous Electrical Stimulation at Jing-Well Acupoints |
| Sham TES Group | Sham comparator | Participants receive sham transcutaneous electrical stimulation at hand Jing-Well acupoint locations using an identical-appearing device with the same electrode placement pattern as the active group. The device delivers ineffective stimulation (0 Hz, no current output) while maintaining identical visual and tactile feedback. Sessions follow the same schedule as the active group: 30 minutes per session, 6 sessions per week for 4 consecutive weeks (24 sessions total). Receives: Device: Transcutaneous Sham Electrical Stimulation at Jing-Well Acupoints |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA(Montreal Cognitive Assessment)
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (3)
Mini-Mental State Examination(MMSE)
Measured: From enrollment to the end of treatment at 4 weeks
Vascular Dementia Assessment Scale-cognitive subscale(VaDAS-cog )
Measured: From enrollment to the end of treatment at 4 weeks
Activities of Daily Living Scale(ADL)
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Stroke Cognitive Impairment (PSCI)Studies of the same condition, open and under way.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Gao Liang, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736885
- Sponsor's protocol ID
- TYLL2026-K-076
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Easton JD, Saver JL, Albers GW, Alberts MJ, Chaturvedi S, Feldmann E, Hatsukami TS, Higashida RT, Johnston SC, Kidwell CS, Lutsep HL, Miller E, Sacco RL; American Heart Association; American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Interdisciplinary Council on Peripheral Vascular Disease. Definition and evaluation of transient ischemic attack: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; and the Interdisciplinary Council on Peripheral Vascular Disease. The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists. Stroke. 2009 Jun;40(6):2276-93. doi: 10.1161/STROKEAHA.108.192218. Epub 2009 May 7.
PubMed 19423857Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.
PubMed 23652265
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Efficacy and Mechanism of Hand Jing-Well Acupoint Transcutaneous Electrical Stimulation in Improving Post-Stroke Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07736885
- Acronym / sponsor ID
- TYLL2026-K-076
- Conditions
- Post-Stroke Cognitive Impairment (PSCI), Ischemic Stroke, Cognitive Dysfunction, Cognitive Disorder, Hemorrhagic Strokes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Tianjin University of Traditional Chinese Medicine
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 30 Jul 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 study evaluates a non-invasive electrical stimulation therapy applied to specific acupoints on the fingers (called Jing-Well points) to improve thinking and memory problems after stroke.
Purpose: Many stroke survivors develop cognitive difficulties (problems with memory, attention, and decision-making). Current treatments are limited. This study tests whether gentle electrical stimulation to hand acupoints can improve these symptoms.
Who can participate: Adults aged [35-80] who have had an ischemic stroke and now have mild to moderate cognitive impairment.
What happens: Participants will be randomly assigned to receive either (1) active electrical stimulation to hand Jing-Well points, (2) sham (fake) stimulation. Treatment will last 4 weeks, 6 sessions per week, each 30 minutes, with a stimulation frequency of 10 Hz and intensity adjusted to each participant's tolerance. Cognitive tests and brain imaging will be done before and after treatment.
Potential benefits: Participants may experience improved cognitive function. The study will also help researchers understand how this therapy works in the brain.
Risks: The electrical stimulation may cause mild tingling or skin irritation at the electrode sites. Brain imaging is non-invasive and safe. All procedures will be performed by trained professionals.
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 |
|---|---|---|
| Active TES Group | Experimental | Device: Transcutaneous Electrical Stimulation at Jing-Well AcupointsParticipants receive transcutaneous electrical stimulation at hand Jing-Well acupoints (Shaoze SI1, Shangyang LI1, Zhongchong PC9, Guanchong SJ1, Shaochong HT9, and Dadun LR1) using a portable stimulator. Stimulation parameters: 10 Hz square wave, pulse width 320 μs, intensity adjusted to individual tolerance (typically 0-1 mA), 30 minutes per session, 6 sessions per week for 4 consecutive weeks (24 sessions total). |
| Sham TES Group | Sham comparator | Device: Transcutaneous Sham Electrical Stimulation at Jing-Well AcupointsParticipants receive sham transcutaneous electrical stimulation at hand Jing-Well acupoint locations using an identical-appearing device with the same electrode placement pattern as the active group. The device delivers ineffective stimulation (0 Hz, no current output) while maintaining identical visual and tactile feedback. Sessions follow the same schedule as the active group: 30 minutes per session, 6 sessions per week for 4 consecutive weeks (24 sessions total). |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 35-80 years;
- Stroke duration within 2 weeks to 6 months post-onset;
- Cognitive impairment confirmed by neuropsychological assessment: Montreal Cognitive Assessment (MoCA) score < 26;
- Clinical evaluation excludes delirium, major depressive disorder, schizophrenia, or other primary psychiatric/behavioral disorders as the principal cause of current cognitive impairment. No history of other known neurological diseases that may cause cognitive impairment (e.g., multiple sclerosis, encephalitis, Parkinson's disease, post-traumatic dementia, normal pressure hydrocephalus, etc.);
- No severe aphasia; able to cooperate with scale assessments and complete the treatment protocol required by this study;
Key exclusion criteria (8 listed)
- Unstable vital signs or life-threatening comorbidities;
- Implanted devices (cardiac pacemaker/defibrillator, deep brain stimulator, etc.);
- History of epilepsy or epileptic seizures;
- Pregnant or lactating women;
- Concurrent use of other medications affecting cognitive function;
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 |
|---|---|---|
| Transcutaneous Electrical Stimulation at Jing-Well AcupointsDevice-based transcutaneous electrical stimulation (TES) delivered to six hand Jing-Well acupoints: Shaoze (SI1), Shangyang (LI1), Zhongchong (PC9), Guanchong (SJ1), Shaochong (HT9), and Dadun (LR1). A custom-designed portable electrical stimulator (model YM-JX-V01, manufactured by Yimai Artificial Intelligence Medical Technology (Tianjin) Co., Ltd.) is used with disposable self-adhesive reference electrodes (4 × 4 cm) and stimulation electrodes (diameter 5 mm). Stimulation parameters: square wave, frequency 10 Hz, pulse width 320 μs, intensity individually titrated to sensory threshold (typically 0-1 mA), session duration 30 minutes. Treatment schedule: 6 sessions per week (Monday-Saturday) for 4 consecutive weeks, totaling 24 sessions. Electrodes are placed bilaterally at the designated acupoints according to WHO Standard Acupuncture Point Locations. | Device | Active TES Group |
| Transcutaneous Sham Electrical Stimulation at Jing-Well AcupointsDevice-based sham transcutaneous electrical stimulation (TES) delivered to six hand Jing-Well acupoints: Shaoze (SI1), Shangyang (LI1), Zhongchong (PC9), Guanchong (SJ1), Shaochong (HT9), and Dadun (LR1). A custom-designed portable electrical stimulator with open-circuit design (model YM-JX-V01, manufactured by Yimai Artificial Intelligence Medical Technology (Tianjin) Co., Ltd.) is used with disposable self-adhesive reference electrodes (4 × 4 cm) and stimulation electrodes (diameter 5 mm). The device delivers ineffective stimulation (0 Hz, no current output) while maintaining identical visual and tactile feedback. Sessions follow the same schedule as the active group: 30 minutes per session, 6 sessions per week for 4 consecutive weeks (24 sessions total). Electrodes are placed bilaterally at the designated acupoints according to WHO Standard Acupuncture Point Locations. | Device | Sham TES Group |
Primary outcome
MoCA(Montreal Cognitive Assessment)
Time frame: From enrollment to the end of treatment at 4 weeks
3 secondary outcomes
Mini-Mental State Examination(MMSE)
Time frame: From enrollment to the end of treatment at 4 weeks
Vascular Dementia Assessment Scale-cognitive subscale(VaDAS-cog )
Time frame: From enrollment to the end of treatment at 4 weeks
Activities of Daily Living Scale(ADL)
Time frame: From enrollment to the end of treatment at 4 weeks
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 30 Jul 2026.
- Background: PubMed 19423857Easton JD, Saver JL, Albers GW, Alberts MJ, Chaturvedi S, Feldmann E, Hatsukami TS, Higashida RT, Johnston SC, Kidwell CS, Lutsep HL, Miller E, Sacco RL; American Heart Association; American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Interdisciplinary Council on Peripheral Vascular Disease. Definition and evaluation of transient ischemic attack: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; and the Interdisciplinary Council on Peripheral Vascular Disease. The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists. Stroke. 2009 Jun;40(6):2276-93. doi: 10.1161/STROKEAHA.108.192218. Epub 2009 May 7.
- Background: PubMed 23652265Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Stimulation at Jing-Well Acupoints in people with Post-Stroke Cognitive Impairment (PSCI) and Ischemic Stroke, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 1 site in China.
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 8 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Liang Gao (8618722216295, Gaoliang202605@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA(Montreal Cognitive Assessment) (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07736885, which also lists 2 linked publications.
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 30 Jul 2026.