Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07736885

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300073, China

Location status: Recruiting

Location contact

Liang Gao

CONTACT

[email protected]

8618722216295

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Transcutaneous Electrical Stimulation at Jing-Well Acupoints

Device

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 Acupoints

Device

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.

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)

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

    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.

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

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

    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.

  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

Study contacts

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

Liang Gao

CONTACT

[email protected]

8618722216295

Sponsors and collaborators

Lead sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Other

Collaborators

  • Tianjin University of Traditional Chinese Medicine

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 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.

Published trials that share one or more normalized conditions with this study.