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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorNEUROPHET

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-based Customized transcranial Direct Current Stimulation

    Device

    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

    Device

    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.

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Experimental: AI-Based Customized tDCSExperimental treatment 1 intervention
Group B: Sham Comparator: sham tDCSSham comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline, At 2 weeks from baseline

Secondary 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. Additional analyses will include comparisons between dominant and non-dominant hands.

Time frame
Baseline, At 1, 3, 4, 14 weeks from baseline
2

Wolf Motor Function Test

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.

Time frame
Baseline, At 1, 2, 3, 4, 14 weeks from baseline
3

Box and Blocks Test

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.

Time frame
Baseline, At 1, 2, 3, 4, 14 weeks from baseline
4

Korean version of Modified Barthel Index (K-MBI)

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.

Time frame
Baseline, At 1, 2, 3, 4, 14 weeks from baseline

Other outcomes

Sponsors and contacts

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NEUROPHET

Lead sponsor

Severance Hospital

Collaborator

Asan Medical Center

Collaborator

Bucheon St. Mary's Hospital

Collaborator

Samsung Medical Center

Collaborator

National Rehabilitation Center, Seoul, Korea

Collaborator

National Health Insurance Service Ilsan Hospital

Collaborator

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