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StrokeNCT06740604

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

A study testing BSD-10CH in people with Stroke and TDCS, run by Pusan National University Yangsan Hospital at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Stroke, TDCS
What is being tested?
BSD-10CH
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteSouth Korea
Study dates
21 Feb 2024to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Pusan national university Yangsan Hospital

    Gyeongsang, Yangsan, 50610

Other trials in South Korea

About this study

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

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.

Conditions
Stroke, TDCS
Being tested
BSD-10CH, Sham BSD-10CH
Keywords
Stroke, tDCS
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BSD-10CHDevice

    The BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.

  • Sham BSD-10CHDevice

    The Sham BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.

Study groups in NCT06740604
Study groupRoleWhat they receive
BSD-10CHExperimentalThe BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.
Receives: Device: BSD-10CH
Sham BSD-10CHSham comparatorThe Sham BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.
Receives: Device: Sham BSD-10CH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 4(Visit 22)

  2. 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.

    Measured: Baseline and Week 4(Visit 22)

  3. 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).

    Measured: Baseline and Week 4(Visit 22)

  4. 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.

    Measured: Baseline and Week 4(Visit 22)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study start21 Feb 2024
  3. Primary completion1 Aug 2024
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06740604
Sponsor's protocol ID
23-2024-004
Status last verified
Dec 2024
First submitted
13 Dec 2024
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BSD-10CH in people with Stroke and TDCS, run by Pusan National University Yangsan Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Oxy-Hemoglobin Concentration Description (time frame: Baseline and Week 4(Visit 22)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06740604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.

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