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Not yet recruiting NCT07491029

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

No phase Interventional Subacute Stroke Upper Extremity Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-based Customized transcranial Direct Current Stimulation, Sham transcranial Direct Current Stimulation.
Who it may be relevant to
Registry conditions: Subacute Stroke, Upper Extremity Function. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Fugl-Meyer Function Test [Time frame: Baseline, At 2 weeks from baseline]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Severance Hospital — Seoul

Identifiers

NCT: NCT07491029 · 1-2025-0078

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗