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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Stroke; TDCS
• Intervention / Treatment: Device: BSD-10CH; Device: Sham BSD-10CH

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan
    • Gyeongsang, Yangsan, Korea, Republic of, 50610
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BSD-10CH; The BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.	Device: BSD-10CH; The BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.
Sham Comparator: Sham BSD-10CH; The Sham BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.	Device: Sham BSD-10CH; The Sham BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	Baseline and Week 4(Visit 22)

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Study Director: Young-Il Shin, Dr., Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: tDCS; Stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 23-2024-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No