BSD-10CH TDCS for Upper Limb Function Improvement in Stroke Patients: a Randomized Clinical Trial
NCT ID: NCT06740604
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-02-21
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BSD-10CH
The BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.
BSD-10CH
The BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.
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.
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.
Interventions
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BSD-10CH
The BSD-10CH stimulation was applied five times a week for 4 weeks, with each session lasting 20 minutes per day.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
19 Years
ALL
No
Sponsors
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Pusan National University Yangsan Hospital
OTHER
Responsible Party
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Yong-il Shin
Professor
Principal Investigators
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Young-Il Shin, Dr.
Role: STUDY_DIRECTOR
Pusan National University Yangsan Hospital
Locations
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Pusan national university Yangsan Hospital
Gyeongsang, Yangsan, South Korea
Countries
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Other Identifiers
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23-2024-004
Identifier Type: -
Identifier Source: org_study_id