BSD-10CH TDCS for Upper Limb Function Improvement in Stroke Patients: a Randomized Clinical Trial

Prior treatment

• Previous use of similar stimulation devices or participation in related clinical trials within the last year.
• Participants requiring changes in medications that could affect cognitive or motor function during the study (unless the participant has been on stable, prohibited medications for at least 3 months).

Other illness

• Recurrent stroke, traumatic brain injury, spinal cord injury, degenerative neurological diseases (such as Parkinson's disease), or other conditions affecting upper limb function.
• MMSE score of 19 or lower, indicating dementia, and inability to follow study instructions.
• Global aphasia or communication disorders.
• Brain injury caused by trauma, ischemia, hypoxia, or similar conditions.
• Uncontrolled medical or surgical conditions.
• Medical contraindications for the use of tDCS devices (e.g., pacemaker, aneurysm clips, prosthetic heart valves, cochlear implants, or other implanted metal devices).
• History of major psychiatric disorders (e.g., major depressive disorder, schizophrenia, bipolar disorder, or dementia) within the past 5 years.
• History of epilepsy (seizures) within the past 5 years.
• History of substance abuse (e.g., neuroleptics, sedatives, narcotics, or illicit drugs) within the past 5 years.
• History of alcohol addiction treatment within the last 5 years.
• Severe visual impairment that cannot be corrected with glasses, preventing the reading of standard print.
• Hearing impairment that prevents communication, even with hearing aids.
• A history of suicide attempts within the past 6 months.
• Any other clinical condition deemed by the investigator to make the participant unsuitable for the study.

Age

• Pregnant or breastfeeding women, or men and women of reproductive age who do not agree to use appropriate contraception throughout the study. \*Acceptable methods of contraception include:
  • Hormonal methods (oral contraceptives, injections, patches, implants, etc.)
  • Surgical sterilization (vasectomy, bilateral tubal ligation)
  • Dual protection (male condoms, diaphragm, cervical cap)
  • Intrauterine devices or systems.

Other

• Skin inflammation or other dermatological issues that may prevent attachment of tDCS electrodes.
• Difficulty breathing at rest.
• Pregnant or breastfeeding participants.

• Adults aged 19 years or older.
• Diagnosed with stroke based on clinical observation and neuroimaging.
• First-time stroke patients (1st stroke).
• Stroke onset between 2 weeks and 12 months prior to screening.
• Stroke lesion located in the cortex or subcortex.
• Presence of hemiparesis in the upper limb.
• Upper limb FMA score of 53 or lower.
• Ability to read and understand the informed consent form, and to respond to questionnaires.
• Willing to voluntarily participate in the clinical trial, and able to provide written informed consent to participate throughout the study period.