Clinical trial NCT06740604: BSD-10CH TDCS for Upper Limb Function Improvement in Stroke Patients: a Randomized Clinical Trial
Official title: Evaluation of the Efficacy and Safety of the BSD-10CH Transcranial Direct Current Stimulation Device for Temporary Improvement of Upper Limb Function in Stroke Patients: a Single-Center, Randomized, Blinded, Parallel-Design Investigator-Initiated Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
TDCS
Keywords: Stroke
tDCS
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change in Oxy-Hemoglobin Concentration Description
timeFrame: Baseline and Week 4(Visit 22)
measure: Change in Upper Extremity Function Score of the Korean Version of the Fugl-Meyer Assessment (K-FMA)
timeFrame: Baseline and Week 4(Visit 22)
measure: Change in Grip and Pinch Strength
timeFrame: Baseline and Week 4(Visit 22)
measure: Change in Korean-Modified Barthel Index (K-MBI) score
timeFrame: Baseline and Week 4(Visit 22)
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeongsang
country: Korea, Republic of
facility: Pusan national university Yangsan Hospital
state: Yangsan
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Young-Il Shin, Dr.
role: STUDY_DIRECTOR
References: