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

Neurophet

Status: Not yet enrolling

Conditions: Upper Extremity Function; Subacute Stroke

Treatments: Device: Sham transcranial Direct Current Stimulation; Device: AI-based Customized transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07491029

1-2025-0078

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups

Experimental: AI-Based Customized tDCS

Experimental group

Description:

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.

Treatment:

Device: AI-based Customized transcranial Direct Current Stimulation

Sham Comparator: sham tDCS

Sham Comparator group

Description:

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).

Treatment:

Device: Sham transcranial Direct Current Stimulation