ClinicalTrials.gg
RecruitingNCT07736885Updated Jul 30, 2026

Evaluation of Clinical Efficacy and Mechanism of Hand Jing-Well Acupoint Transcutaneous Electrical Stimulation in Improving Post-Stroke Cognitive Impairment

An interventional study of Transcutaneous Electrical Stimulation at Jing-Well Acupoints and Transcutaneous Sham Electrical Stimulation at Jing-Well Acupoints in Post-Stroke Cognitive Impairment (PSCI), Ischemic Stroke and Cognitive Dysfunction, Cognitive Disorder, sponsored by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
35 Years to 80 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Post-Stroke Cognitive Impairment (PSCI)
  • Ischemic Stroke
  • Cognitive Dysfunction, Cognitive Disorder
  • Hemorrhagic Strokes
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 70 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine is the lead sponsor of 15 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged 35-80 years;
  2. Stroke duration within 2 weeks to 6 months post-onset;
  3. Cognitive impairment confirmed by neuropsychological assessment: (MoCA) score \< 26;
  4. 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.);
  5. No severe aphasia; able to cooperate with scale assessments and complete the treatment protocol required by this study;
  6. Voluntary participation in this study; the participant or their legally authorized representative has signed the form.

Exclusion criteria

Exclusion Criteria:

  1. Unstable vital signs or life-threatening comorbidities;
  2. Implanted devices (cardiac pacemaker/defibrillator, deep brain stimulator, etc.);
  3. History of epilepsy or epileptic seizures;
  4. Pregnant or lactating women;
  5. Concurrent use of other medications affecting cognitive function;
  6. Allergy to the study intervention device or history of serious adverse reactions;
  7. Severe arrhythmia, malignant hypertension, or severe dysfunction of vital organs (heart, liver, kidney, etc.);
  8. Individuals unable to participate in treatment due to severe hearing or visual impairment, or bilateral limb paralysis.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Active TES Group

    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).

    Device: Transcutaneous Electrical Stimulation at Jing-Well Acupoints

  • Sham comparator
    Sham TES Group

    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).

    Device: Transcutaneous Sham Electrical Stimulation at Jing-Well Acupoints

Interventions

  • DeviceTranscutaneous Electrical Stimulation at Jing-Well Acupoints

    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.

  • DeviceTranscutaneous Sham Electrical Stimulation at Jing-Well Acupoints

    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.

06

What researchers measure

Primary outcomes

  1. MoCA(Montreal Cognitive Assessment)

    Time frame: From enrollment to the end of treatment at 4 weeks

Secondary outcomes

  1. Mini-Mental State Examination(MMSE)

    Time frame: From enrollment to the end of treatment at 4 weeks

  2. Vascular Dementia Assessment Scale-cognitive subscale(VaDAS-cog )

    Time frame: From enrollment to the end of treatment at 4 weeks

  3. Activities of Daily Living Scale(ADL)

    Time frame: From enrollment to the end of treatment at 4 weeks

Other outcomes

  1. Whole-brain frequency band absolute and relative power derived from resting-state electroencephalography (EEG)

    Resting-state EEG signals will be acquired. Absolute power and relative power of multiple frequency bands (delta, theta, alpha, beta) across the whole brain will be quantified to reflect cortical electrical activity.

    Time frame: From enrollment to the end of treatment at 4 weeks

  2. Concentration changes of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) measured by functional near-infrared spectroscopy (fNIRS)

    Prefrontal cortical hemodynamic signals will be acquired via resting-state functional near-infrared spectroscopy. Concentration changes of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) will be quantified to evaluate cerebral hemodynamic function.

    Time frame: From enrollment to the end of treatment at 4 weeks

  3. C-Reactive Protein

    Time frame: From enrollment to the end of treatment at 4 weeks

  4. Folic Acid / Folate

    Time frame: From enrollment to the end of treatment at 4 weeks

  5. Homocysteine(Hcy)

    Time frame: From enrollment to the end of treatment at 4 weeks

  6. Vitamin B12 / Cobalamin

    Time frame: From enrollment to the end of treatment at 4 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 19423857 ↗
  • Sacco 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Mar 2027, 7 months later.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 7 months is below that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2026
First posted
Jul 30, 2026
StartEst.
Aug 15, 2026
Primary completionEst.
Mar 30, 2027
CompletionEst.
Mar 30, 2027
Last update
Jul 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07736885
Lead sponsor
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Collaborators
Tianjin University of Traditional Chinese Medicine
Responsible party
Gao Liang (Associate Chief Physician, Department of Acupuncture, First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine) — Principal investigator
First posted
Jul 30, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Mar 30, 2027 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Jul 30, 2026

Study contacts

Liang Gao
Contact
Gaoliang202605@163.com
8618722216295

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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