AI-based Customized tDCS for Finger Motor Recovery After Subacute Stroke
A Multi-center, Randomized, Double-blind, Prospective, Superiority Clinical Trial to Evaluate the Safety and Effectiveness of Artificial Intelligence-based Customized Transcranial Direct Current Stimulation Using MR Images for Improving Finger Motor Function in Patients With Finger Paralysis Due to Subacute Stroke
1 other identifier
interventional
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2026
CompletedFirst Posted
Study publicly available on registry
March 24, 2026
CompletedStudy Start
First participant enrolled
April 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 24, 2026
March 1, 2026
1.3 years
March 16, 2026
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fugl-Meyer Function Test
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.
Baseline, At 2 weeks from baseline
Secondary Outcomes (7)
Fugl-Meyer Function Test
Baseline, At 1, 3, 4, 14 weeks from baseline
Wolf Motor Function Test
Baseline, At 1, 2, 3, 4, 14 weeks from baseline
Box and Blocks Test
Baseline, At 1, 2, 3, 4, 14 weeks from baseline
Korean version of Modified Barthel Index (K-MBI)
Baseline, At 1, 2, 3, 4, 14 weeks from baseline
Grip Strength
Baseline, At 1, 2, 3, 4, 14 weeks from baseline
- +2 more secondary outcomes
Study Arms (2)
Experimental: AI-Based Customized tDCS
EXPERIMENTALParticipants receive customized stimulation obtained from an individualized T1 MRI-based simulation of transcranial direct current stimulation for 30 minutes, once a day for 2 weeks, for a total of 10 sessions.
Sham Comparator: sham tDCS
SHAM COMPARATORParticipants receive sham stimulation for 30 minutes once daily for 2 weeks (10 sessions total). Electrodes are placed according to the AI-based customized montage, but no current is delivered (0 mA).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Participants must meet all of the following criteria to be eligible for this clinical trial:
- Adults aged 19 years or older
- Patients with stroke confirmed by brain imaging
- Subacute stroke patients within 2 weeks to 3 months after stroke onset
- Patients with unilateral upper-extremity paralysis
- Upper-extremity Fugl-Meyer Assessment (FMA-UE, maximum score 66) score between 20 and 56
- Participants who voluntarily provide written informed consent after receiving and understanding the study procedures and requirements
You may not qualify if:
- Participants will be excluded if they meet any of the following criteria:
- History of a condition affecting the function of the paralyzed arm
- Inability to follow instructions or complete the study due to cognitive impairment or aphasia
- Evidence of delirium, confusion, or other disorders of consciousness
- Presence of uncontrolled medical or surgical conditions
- Severe neurological disorders associated with major psychiatric conditions (e.g., major depressive disorder, schizophrenia, bipolar disorder, or dementia)
- History of uncontrolled epilepsy (seizure disorder)
- 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
- Medical contraindications to MRI examination
- Pregnant or breastfeeding women, or those planning pregnancy during the study period
- Use of a stimulation device similar to the investigational device or participation in a related clinical study within the past 1 year
- Individuals judged by the investigator to be medically or ethically unsuitable for participation in this clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NEUROPHETlead
- Severance Hospitalcollaborator
- Asan Medical Centercollaborator
- Bucheon St. Mary's Hospitalcollaborator
- Samsung Medical Centercollaborator
- National Rehabilitation Center, Seoul, Koreacollaborator
- National Health Insurance Service Ilsan Hospitalcollaborator
Study Sites (1)
Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Deog Young Kim
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2026
First Posted
March 24, 2026
Study Start
April 30, 2026
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share