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Clinical Trial NCT07491029 for Subacute Stroke, Upper Extremity Function is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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AI-based Customized tDCS for Finger Motor Recovery After Subacute Stroke 116
Clinical Trial NCT07491029 is an interventional study for Subacute Stroke, Upper Extremity Function and is currently not yet recruiting. Enrollment is planned to begin on 30 April 2026 and continue until the study accrues 116 participants. Led by NEUROPHET, this study is expected to complete by 31 December 2027. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
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 me...
Official Title
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
Conditions
Subacute StrokeUpper Extremity FunctionOther Study IDs
- 1-2025-0078
NCT ID Number
Start Date (Actual)
2026-04-30
Last Update Posted
2026-03-24
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
116
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
tDCS
stroke
rehabilitation
finger paralysis
upper extremity
transcranial direct current stimulation
upper limb motor function
stroke
rehabilitation
finger paralysis
upper extremity
transcranial direct current stimulation
upper limb motor function
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalExperimental: AI-Based Customized tDCS Participants 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. | 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 ComparatorSham Comparator: sham tDCS Participants 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). | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Baseline, At 1, 3, 4, 14 weeks from baseline |
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. | Baseline, At 1, 2, 3, 4, 14 weeks from baseline |
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. | Baseline, At 1, 2, 3, 4, 14 weeks from baseline |
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. | Baseline, At 1, 2, 3, 4, 14 weeks from baseline |
Grip Strength | 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. | Baseline, At 1, 2, 3, 4, 14 weeks from baseline |
EuroQol 5-Dimension 5-Level (EQ-5D-5L) | 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. | Baseline, At 2, 14 weeks from baseline |
Motor-Evoked Potential (MEP) | 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). | Baseline, At 2 weeks from baseline |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
19 Years
Eligible Sexes
All
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
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
NEUROPHET- 🏥Severance Hospital...
Study Central Contact
Contact: TaeYeong Kim, 827051678882, [email protected]
Contact: Soo Young Whang, [email protected]
1 Study Locations in 1 Countries
Severance Hospital, Seoul, South Korea