Severance Hospital
Seoul, South Korea
NCT Number: NCT07491029
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 opening soon.
Get Notified19 year and older
All sexes
Interventional
Not applicable
Seoul, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must meet all of the following criteria to be eligible for this clinical trial:
Exclusion criteria
Participants will be excluded if they meet any of the following criteria:
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.
Other names: NEUROPHET tES LAB, NEUROPHET innk01-DW
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.
Other names: NEUROPHET tES LAB, NEUROPHET innk01-DW
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
NEUROPHET
Industry
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
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.
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