NCT07736885

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

July 18, 2026

Last Update Submit

July 26, 2026

Conditions

Post-Stroke Cognitive Impairment (PSCI)Ischemic StrokeHemorrhagic StrokesCognitive Dysfunction, Cognitive Disorder

Outcome Measures

Primary Outcomes (1)

  • MoCA（Montreal Cognitive Assessment)

    From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (3)

  • Mini-Mental State Examination（MMSE）

    From enrollment to the end of treatment at 4 weeks

  • Vascular Dementia Assessment Scale-cognitive subscale（VaDAS-cog ）

    From enrollment to the end of treatment at 4 weeks

  • Activities of Daily Living Scale（ADL）

    From enrollment to the end of treatment at 4 weeks

Other Outcomes (6)

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

    From enrollment to the end of treatment at 4 weeks

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

    From enrollment to the end of treatment at 4 weeks

  • C-Reactive Protein

    From enrollment to the end of treatment at 4 weeks

  • +3 more other outcomes

Study Arms (2)

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).

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).

Device: Transcutaneous Sham Electrical Stimulation at Jing-Well Acupoints

Interventions

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.

Active TES Group
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.

Sham TES Group

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300073, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 19423857BACKGROUND

  • 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.

    PMID: 23652265BACKGROUND

MeSH Terms

Conditions

Ischemic StrokeCognitive DysfunctionHemorrhagic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Liang Gao

CONTACT

8618722216295Gaoliang202605@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician, Department of Acupuncture, First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Study Record Dates

First Submitted

July 18, 2026

First Posted

July 30, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)