Cognitive Dysfunction, Cognitive Disorder, Hemorrhagic Strokes, Ischemic Stroke, Post-Stroke Cognitive Impairment (PSCI)
Conditions
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.
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.
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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: Montreal Cognitive 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 informed consent form.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MoCA（Montreal Cognitive Assessment) | From enrollment to the end of treatment at 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
CONTACTLiang Gao
Outcome results
None listed