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

Pusan National University Yangsan Hospital

Status

Active, not recruiting

Conditions

Stroke

TDCS

Treatments

Device: Sham BSD-10CH

Device: BSD-10CH

Study type

Interventional

Funder types

Other

Identifiers

NCT06740604

23-2024-004

Details and patient eligibility

About

This clinical study compares the effectiveness and safety of the BSD-10CH transcranial direct current stimulation (tDCS) device, applied alongside rehabilitation therapy, with a control device in stroke patients. After 4 weeks of treatment, the study evaluates the transient improvement in motor cortex activation and upper extremity function between the two groups.

Enrollment

60 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.
Skin inflammation or other dermatological issues that may prevent attachment of tDCS electrodes.
Medical contraindications for the use of tDCS devices (e.g., pacemaker, aneurysm clips, prosthetic heart valves, cochlear implants, or other implanted metal devices).
Previous use of similar stimulation devices or participation in related clinical trials within the last year.
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.
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).
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.
Difficulty breathing at rest.
A history of suicide attempts within the past 6 months.
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.
Pregnant or breastfeeding participants.
Any other clinical condition deemed by the investigator to make the participant unsuitable for the study.