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

March 19, 2026 updated by: NEUROPHET

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: 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.
Device: 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.
Other Names:
  • NEUROPHET tES LAB, NEUROPHET innk01-DW
Sham Comparator: Sham 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).
Device: 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.
Other Names:
  • NEUROPHET tES LAB, NEUROPHET innk01-DW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Function Test
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.
Baseline, At 2 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Function Test
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.
Baseline, At 1, 3, 4, 14 weeks from baseline
Wolf Motor Function Test
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.
Baseline, At 1, 2, 3, 4, 14 weeks from baseline
Box and Blocks Test
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.
Baseline, At 1, 2, 3, 4, 14 weeks from baseline
Korean version of Modified Barthel Index (K-MBI)
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.
Baseline, At 1, 2, 3, 4, 14 weeks from baseline
Grip Strength
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.
Baseline, At 1, 2, 3, 4, 14 weeks from baseline
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
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.
Baseline, At 2, 14 weeks from baseline
Motor-Evoked Potential (MEP)
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).
Baseline, At 2 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NEUROPHET

Collaborators

Samsung Medical Center
Asan Medical Center
Severance Hospital
National Rehabilitation Center, Seoul, Korea
Bucheon St. Mary's Hospital
National Health Insurance Service Ilsan Hospital

Investigators

  • Study Chair: Deog Young Kim, Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2025-0078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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