StrokeNCT05142917
The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients
A study testing Transcranial Direct Current Stimulation and Hand motor task in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate whether brain imaging-based hand function area tDCS stimulation is more effective than conventional stimulation or sham stimulation for improving hand motor function. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial Direct Current Stimulation and Hand motor task
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Feb 2022to 8 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral stroke patients aged 19 to 80 years
- Patients with subacute stroke within 4 weeks of onset
- Patients with moderate or severe upper extremity dysfunction with an upper extremity FMA score of less than 58 in motor function evaluation
Who cannot join
- Accompanied by an existing serious neurogenic disease
- Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder, and dementia.
- If there are difficulties in conducting the research
- Any patients who are judged by the investigator to be difficult to participate in this study
- Exclusion criteria for transcranial direct current stimulation:
- Patients with implanted medical devices in the body (e.g. pacemakers) ii) When a metal object is inserted in the skull iii) If there is a wound on the skin of the attachment site iv) history of epilepsy v) Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate whether brain imaging-based hand function area tDCS stimulation is more effective than conventional stimulation or sham stimulation for improving hand motor function.
- Conditions
- Stroke
- Being tested
- Transcranial Direct Current Stimulation, Hand motor task
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.
Hand motor taskBehavioural
Various type of hand motor tasks are applied to stroke patients.
| Study group | Role | What they receive |
|---|---|---|
| fNIRS based hand motor area real stimulation | Experimental | Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes). Receives: Device: Transcranial Direct Current Stimulation; Behavioral: Hand motor task |
| Traditional hand motor area real stimulation | Active comparator | Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes). Receives: Device: Transcranial Direct Current Stimulation; Behavioral: Hand motor task |
| Traditional hand motor area sham stimulation | Sham comparator | Sham stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes). Receives: Behavioral: Hand motor task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of score: Fugl-Meyer Assessment
The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.
Measured: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Secondary outcomes (8)
Changes of score: 9-hole pegboard test
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Measured: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes of score: Grip & Tip pinch strength test
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
Measured: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes in Box & Block test
The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.
Measured: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes of score: Jebsen-Taylor hand function test
This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
Measured: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes of score: Korean-Montreal Cognitive Assessment
This test is a cognitive function test tool consisting of spatiotemporal/executive function, naming, memory, attention, language function, abstraction, and orientation.
Measured: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes of score: Korean version of Modified Barthel Index
Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions.
Measured: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes of score: Geriatric Depression Scale-Short Form
The test is a self-report measure of depression in older adults.
Measured: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes in cortical activity using fNIRS signals
Cortical activities before, during and after brain stimulation sessions are compared.
Measured: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start11 Feb 2022
- Primary completion8 Jan 2023
- Study completion8 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142917
- Sponsor's protocol ID
- 2021-10-092-001
- Status last verified
- Nov 2021
- First submitted
- 28 Nov 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT05142917
- Acronym / sponsor ID
- 2021-10-092-001
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 8 Jan 2023 (actual)
- Study completion
- 8 Jan 2023 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether brain imaging-based hand function area tDCS stimulation is more effective than conventional stimulation or sham stimulation for improving hand motor function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fNIRS based hand motor area real stimulation | Experimental | Device: Transcranial Direct Current Stimulation, Behavioral: Hand motor taskReal stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes). |
| Traditional hand motor area real stimulation | Active comparator | Device: Transcranial Direct Current Stimulation, Behavioral: Hand motor taskReal stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes). |
| Traditional hand motor area sham stimulation | Sham comparator | Behavioral: Hand motor taskSham stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes). |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral stroke patients aged 19 to 80 years
- Patients with subacute stroke within 4 weeks of onset
- Patients with moderate or severe upper extremity dysfunction with an upper extremity FMA score of less than 58 in motor function evaluation
Key exclusion criteria (6 listed)
- Accompanied by an existing serious neurogenic disease
- Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder, and dementia.
- If there are difficulties in conducting the research
- Any patients who are judged by the investigator to be difficult to participate in this study
- Exclusion criteria for transcranial direct current stimulation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationTranscranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp. | Device | Traditional hand motor area real stimulation, fNIRS based hand motor area real stimulation |
| Hand motor taskVarious type of hand motor tasks are applied to stroke patients. | Behavioural | Traditional hand motor area real stimulation, Traditional hand motor area sham stimulation, fNIRS based hand motor area real stimulation |
Primary outcome
Changes of score: Fugl-Meyer Assessment
Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.
8 secondary outcomes
Changes of score: 9-hole pegboard test
Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes of score: Grip & Tip pinch strength test
Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes in Box & Block test
Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes of score: Jebsen-Taylor hand function test
Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes of score: Korean-Montreal Cognitive Assessment
Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes of score: Korean version of Modified Barthel Index
Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes of score: Geriatric Depression Scale-Short Form
Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Changes in cortical activity using fNIRS signals
Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation and Hand motor task in people with Stroke, run by Samsung Medical Center 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 1 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes of score: Fugl-Meyer Assessment (time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2023.