The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300073, China
Location status: Recruiting
NCT Number: NCT07736885
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.
Interested in participating?
Request Info35 year–80 year
All sexes
Interventional
Not applicable
Tianjin, Tianjin Municipality, 300073, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From enrollment to the end of treatment at 4 weeks
Time frame: From enrollment to the end of treatment at 4 weeks
Time frame: From enrollment to the end of treatment at 4 weeks
Time frame: From enrollment to the end of treatment at 4 weeks
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.
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.
Time frame: From enrollment to the end of treatment at 4 weeks
Time frame: From enrollment to the end of treatment at 4 weeks
Time frame: From enrollment to the end of treatment at 4 weeks
Time frame: From enrollment to the end of treatment at 4 weeks
Contact information is provided by the study sponsor or research team.
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Other
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.
NCT07125170
Brain Diseases, Cardiovascular Diseases
Independencia, Santiago Metropolitan, Chile
View Trial DetailsNCT07546877
Brain Diseases, Cardiovascular Diseases
Jinan, China
View Trial DetailsNCT07452276
Artifical Intelligence, Brain Diseases
Cairo, Egypt
View Trial DetailsNCT07208019
Brain Diseases, Cardiovascular Diseases
Hangzhou, Zhejiang, China
View Trial Details