bsd-10ch tdcs for upper limb function improvement in stroke patients: a randomized clinical trial

Conditions: Stroke; TDCS

Summary: 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.


Eligibility criteria:
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.

Keywords: stroke tdcs