Subacute StrokeNCT07491029
AI-based Customized tDCS for Finger Motor Recovery After Subacute Stroke
A study testing AI-based Customized transcranial Direct Current Stimulation in people with Subacute Stroke and Upper Extremity Function, run by NEUROPHET at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Subacute Stroke, Upper Extremity Function
- What is being tested?
- AI-based Customized transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Soo Young Whang contact
About this study
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
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.
- Conditions
- Subacute Stroke, Upper Extremity Function
- Being tested
- AI-based Customized transcranial Direct Current Stimulation, Sham transcranial Direct Current Stimulation
- Keywords
- tDCS, stroke, rehabilitation, finger paralysis, upper extremity, transcranial direct current stimulation, upper limb motor function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based Customized transcranial Direct Current StimulationDevice
Also called NEUROPHET tES LAB, NEUROPHET innk01-DW
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 StimulationDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: AI-Based Customized tDCS | Experimental | 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. Receives: Device: AI-based Customized transcranial Direct Current Stimulation |
| Sham Comparator: sham tDCS | Sham comparator | 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). Receives: Device: Sham transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, At 2 weeks from baseline
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, At 2 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start30 Apr 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NEUROPHET
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital, Asan Medical Center, Bucheon St. Mary's Hospital, Samsung Medical Center, National Rehabilitation Center, Seoul, Korea, National Health Insurance Service Ilsan Hospital
- Responsible party
- Sponsor
- Investigators
- Deog Young Kim, Study chair, Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491029
- Sponsor's protocol ID
- 1-2025-0078
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07491029
- Acronym / sponsor ID
- 1-2025-0078
- Conditions
- Subacute Stroke, Upper Extremity Function
- Keywords
- tDCS, stroke, rehabilitation, finger paralysis, upper extremity, transcranial direct current stimulation, upper limb motor function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- NEUROPHETIndustry (pharma, biotech, devices)
- Collaborators
- Severance Hospital, Asan Medical Center, Bucheon St. Mary's Hospital, Samsung Medical Center, National Rehabilitation Center, Seoul, Korea, National Health Insurance Service Ilsan Hospital
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: AI-Based Customized tDCS | Experimental | Device: AI-based Customized transcranial Direct Current StimulationParticipants 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 comparator | Device: Sham transcranial Direct Current StimulationParticipants 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). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-based Customized transcranial Direct Current StimulationAlso: NEUROPHET tES LAB, NEUROPHET innk01-DWTranscranial 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. | Device | Experimental: AI-Based Customized tDCS |
| Sham transcranial Direct Current StimulationAlso: NEUROPHET tES LAB, NEUROPHET innk01-DWTranscranial 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. | Device | Sham Comparator: sham tDCS |
Primary outcome
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.
7 secondary outcomes
Fugl-Meyer Function Test
Time frame: 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
Box and Blocks Test
Time frame: 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
Grip Strength
Time frame: 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
Motor-Evoked Potential (MEP)
Time frame: Baseline, At 2 weeks from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Subacute Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation
Stroke
Active, not recruiting
Comparative Effects of Sensorimotor Training and tACS on Upper Limb Function and Cervical Proprioception in Subacute Stroke
Sub-acute Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soo Young Whang contact
Deog Young Kim study chair
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based Customized transcranial Direct Current Stimulation in people with Subacute Stroke and Upper Extremity Function, run by NEUROPHET at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TaeYeong Kim (827051678882, ty.kim@neurophet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Function Test (time frame: Baseline, At 2 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.