Subacute Stroke, Upper Extremity Function
Conditions
Keywords
tDCS, stroke, rehabilitation, finger paralysis, upper extremity, transcranial direct current stimulation, upper limb motor function
Brief 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.
Interventions
DEVICEAI-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.
DEVICESham 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.
Sponsors
NEUROPHET
Severance Hospital
Asan Medical Center
Bucheon St. Mary's Hospital
Samsung Medical Center
National Rehabilitation Center, Seoul, Korea
National Health Insurance Service Ilsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Function Test | Baseline, At 1, 3, 4, 14 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. Additional analyses will include comparisons between dominant and non-dominant hands. |
| Wolf Motor Function Test | Baseline, At 1, 2, 3, 4, 14 weeks from baseline | The Wolf Motor Function Test (WMFT) is a validated assessment used to evaluate upper-extremity motor function in individuals with mild to moderate impairment following stroke or traumatic brain injury. The test is based on direct observation of the participant's performance. The assessment consists of 19 tasks evaluating upper-extremity function. For items 1-15, performance time and functional ability are measured. Functional ability is rated on a 6-point scale from 0 (does not attempt the task) to 5 (normal performance), and task completion time is recorded with a maximum limit of 120 seconds per task. Two additional items assess upper-extremity strength and grip strength. Additional analyses will include comparisons between dominant and non-dominant hands. |
| Box and Blocks Test | Baseline, At 1, 2, 3, 4, 14 weeks from baseline | The Box and Blocks Test (BBT) is a standardized assessment used to evaluate upper-extremity gross manual dexterity and coordination. During the test, participants move wooden blocks one at a time from one compartment of a box to another over a partition using one hand. The test is performed for 1 minute for each hand. The total number of blocks successfully transferred within the time limit is recorded as the score. If more than one block is moved at the same time, the additional blocks are not counted. Additional analyses will include comparisons between dominant and non-dominant hands. |
| Korean version of Modified Barthel Index (K-MBI) | Baseline, At 1, 2, 3, 4, 14 weeks from baseline | The Modified Barthel Index (MBI) is a standardized assessment used to evaluate activities of daily living (ADL). The scale consists of 10 items assessing functional independence, including personal hygiene, bathing, feeding, toileting, stair climbing, dressing, bowel control, bladder control, ambulation (or wheelchair use), and transfers between a bed and chair. Each item is scored according to the level of assistance required, with a total score ranging from 0 to 100. Lower scores indicate greater dependence in daily activities, while scores between 91 and 99 indicate minimal dependence. The MBI is widely used due to its reliability, sensitivity, and practicality for evaluating functional recovery and mobility in rehabilitation. Additional analyses will include comparisons between dominant and non-dominant hands. |
| Grip Strength | Baseline, At 1, 2, 3, 4, 14 weeks from baseline | Grip strength is measured to assess hand muscle strength of the affected and unaffected upper extremity. Participants squeeze a hand dynamometer with maximum effort, and the measured force is recorded as the grip strength value. Additional analyses will include comparisons between dominant and non-dominant hands. |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Baseline, At 2, 14 weeks from baseline | Quality of life (QoL) will be assessed using the EQ-5D-5L, a standardized self-reported questionnaire. The instrument evaluates five dimensions of health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels ranging from "no problems" (Level 1) to "extreme problems or inability to perform" (Level 5). Participants select the level that best describes their current health status, generating a health profile. The EQ-5D-5L will be used to compare changes in quality of life between the intervention and sham groups. |
| Motor-Evoked Potential (MEP) | Baseline, At 2 weeks from baseline | The cortical excitability of the area corresponding to the swallowing movement will be assessed by changes in the amplitude and latency of the MEPs by using transcranial magnetic stimulation (TMS). |
Countries
South Korea
Contacts
CONTACTTaeYeong Kim
CONTACTSoo Young Whang
STUDY_CHAIRDeog Young Kim
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea
Outcome results
None listed