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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
The BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.
The Sham BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.
Pusan national university Yangsan Hospital
Gyeongsang, Yangsan, South Korea
Change in Oxy-Hemoglobin Concentration Description
Functional Near-Infrared Spectroscopy (fNIRS) will be used to measure changes in oxy-hemoglobin concentration in the brain, reflecting alterations in cerebral blood flow and neurovascular reactivity (NVR) during transcranial direct current stimulation (tDCS). fNIRS works by detecting changes in the absorption, scattering, and reflection of near-infrared light (ranging from 800 nm to 2500 nm), which are associated with the concentration changes of oxy-hemoglobin and deoxy-hemoglobin. This technique allows for the assessment of cerebral oxygenation, blood flow, and energy metabolism, providing insights into neurovascular coupling.
Time frame: Baseline and Week 4(Visit 22)
Change in Upper Extremity Function Score of the Korean Version of the Fugl-Meyer Assessment (K-FMA)
The Korean version of the Fugl-Meyer Assessment (K-FMA) is a tool used to evaluate the recovery of upper extremity function in stroke patients with hemiplegia. It assesses sensory and motor function through 63 items, with a total score ranging from 0 to 126 points. The assessment covers categories such as shoulder, elbow, forearm, wrist, hand, upper extremity coordination, sensation, passive joint movement, and joint pain during passive movement. Recovery is measured by comparing the baseline score to the score after 4 weeks.
Time frame: Baseline and Week 4(Visit 22)
Change in Grip and Pinch Strength
Grip strength is measured using the Jamar Hydraulic Hand Dynamometer (5030J1). The handle is fixed at level II regardless of hand size. Pinch strength is measured using the Jamar Pinch Gauge (PG 60). First, grip strength is measured on both sides, followed by the measurement of tip pinch strength on both sides. Subsequently, 3-jaw pinch and lateral pinch strengths are measured in the same manner. After a 5-minute rest, grip strength and the three types of pinch strengths are measured again to calculate the average. Tip pinch measures the force between the thumb and index finger tip, lateral pinch measures the force between the thumb and the side of the index finger, and 3-jaw pinch measures the force between the thumb and the index-middle finger. During grip strength measurement, the subject sits in a chair with the shoulder adducted and not rotated, the elbow flexed at 90°, and the forearm and wrist in a neutral position. The scores are recorded in grams (g).
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Time frame: Baseline and Week 4(Visit 22)
Change in Korean-Modified Barthel Index (K-MBI) score
The K-MBI is an assessment tool used to evaluate a patient's ability to perform activities of daily living. It consists of 10 items that measure the level of independence or dependence in tasks such as personal hygiene, bathing, eating, toileting, mobility, stair climbing, dressing, bowel and bladder control, transfers between chair/bed, and using a bathtub or shower. Scores range from 0 (completely dependent) to 100 (completely independent). The change is calculated by subtracting the baseline score from the Week 4 score.
Time frame: Baseline and Week 4(Visit 22)