AI-based Customized tDCS for Finger Motor Recovery After Subacute Stroke

NCT07491029 · tracked via the Priya Life Science South Korea tracker

Sponsor

NEUROPHET

Phase

Not applicable

Started

2026-04-30

Last updated

2026-03-24

Condition(s) studied

Subacute StrokeUpper Extremity Function

Investigational drug(s) / intervention(s)

AI-based Customized transcranial Direct Current StimulationSham transcranial Direct Current Stimulation

AI-based Customized transcranial Direct Current Stimulation: Transcranial direct current stimulation (2 mA for 30 minutes) will be delivered using electrode positions optimized by an AI-based simulation based on each participant's MR images to target the motor cortex.

Sham transcranial Direct Current Stimulation: Transcranial direct current stimulation (0 mA for 30 minutes) will be delivered using electrode positions optimized by an AI-based simulation based on each participant's MR images.

Study summary

The goal of this clinical study is to evaluate whether AI-based customized transcranial direct current stimulation (tDCS) using MR images is more effective than sham stimulation in improving finger motor function in patients with finger paralysis caused by subacute stroke. The main questions it aims to answer are:

* Does AI-based customized tDCS improve finger motor function compared with sham stimulation?
* What medical problems or adverse events occur when participants receive AI-based customized tDCS?

Researchers will compare AI-based customized tDCS with sham stimulation (a look-alike stimulation that delivers no electrical current) to determine whether the intervention improves finger motor recovery in patients with subacute stroke.

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Participants must meet all of the following criteria to be eligible for this clinical trial: 1. Adults aged 19 years or older 2. Patients with stroke confirmed by brain imaging 3. Subacute stroke patients within 2 weeks to 3 months after stroke onset 4. Patients with unilateral upper-extremity paralysis 5. Upper-extremity Fugl-Meyer Assessment (FMA-UE, maximum score 66) score between 20 and 56 6. Participants who voluntarily provide written informed consent after receiving and understanding the study procedures and requirements Exclusion Criteria: Participants will be excluded if they meet any of the following criteria: 1. History of a condition affecting the function of the paralyzed arm 2. Inability to follow instructions or complete the study due to cognitive impairment or aphasia 3. Evidence of delirium, confusion, or other disorders of consciousness 4. Presence of uncontrolled medical or surgical conditions 5. Severe neurological disorders associated with major psychiatric conditions (e.g., major depressive disorder, schizophrenia, bipolar disorder, or dementia) 6. History of uncontrolled epilepsy (seizure disorder) 7. Contraindications to transcranial direct current stimulation (tDCS), including: * Scalp disease or metal materials at the electrode attachment site * Presence of a cardiac pacemaker or cochlear implant 8. Medical contraindications to MRI examination 9. Pregnant or breastfeeding women, or those planning pregnancy during the study period 10. Use of a stimulation device similar to the investigational device or participation in a related clinical study within the past 1 year 11. Individuals judged by the investigator to be medically or ethically unsuitable for participation in this clinical study

Primary outcome measure(s)

Fugl-Meyer Function Test — Baseline, At 2 weeks from baseline
The Fugl-Meyer Assessment (FMA) is a validated clinical scale used to evaluate sensorimotor recovery in patients with post-stroke hemiplegia based on Brunnstrom stages of motor recovery. Each item is scored on a 3-point scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). In this study, the upper-extremity FMA will be used. The assessment includes items evaluating the shoulder, elbow, forearm, wrist, hand (fingers), coordination/speed, sensation, passive joint motion, and joint pain during passive movement, with a total score ranging from 0 to 126 points.

Trial sites (1)

Facility	City	Region	Status
Severance Hospital	Seoul	South Korea

More NEUROPHET trials in South Korea

Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07491029 on ClinicalTrials.gov ↗ ← All trials in South Korea