StrokeNCT04699331
Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients
A study testing Transcranial Direct Current Stimulation in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jan 2021to 23 Dec 2022
- 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
- Chronic patients over 6 months after onset
- Patients with motor evoked potential of the first dorsal interosseous muscle
- Patients with the movement of fingers
Who cannot join
- History of psychiatric disease
- Significant other neurological diseases except for stroke
- Difficult to perform this experiment
- Patients who are deemed difficult to participate in this research by the investigator
- Patients with metal implants and medical devices
- History of epilepsy
- Pregnancy
- Skin defect at the site of electrode attachment
Trial locations and contacts
1 site in 1 country.
About this study
This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.
- Conditions
- Stroke
- Being tested
- Transcranial Direct Current Stimulation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized stimulation group | Experimental | Patients receive five sessions of individualized stimulation obtained from brain image-based transcranial direct stimulation simulation. The simulator generates the electrode's location on the scalp. Receives: Device: Transcranial Direct Current Stimulation |
| Conventional stimulation group | Active comparator | Patients receive five sessions of conventional stimulation with electrodes over C3 and C4 based on the 10-20 system. Receives: Device: Transcranial Direct Current Stimulation |
| Sham stimulation group | Sham comparator | Patients receive five sessions of sham stimulation with electrodes over C3 and C4 based on the 10-20 system. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in motor evoked potential
Resting motor threshold (rMT), amplitude, and latency of motor evoked potential in the first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response. The latency is defined as the time point from the onset of the stimulus to the onset of MEP.
Measured: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Secondary outcomes (6)
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, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
9-hole peg test
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Measured: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Grip & Tip pinch strength test
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
Measured: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Sequential motor test
Response time and accuracy are measured during finger tapping task.
Measured: Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start29 Jan 2021
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pusan National University Yangsan Hospital
- Responsible party
- Principal investigator, Yun-Hee Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699331
- Sponsor's protocol ID
- 2019-07-107
- Status last verified
- Feb 2023
- First submitted
- 5 Jan 2021
- Last updated
- 3 Feb 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 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients
- ClinicalTrials.gov ID
- NCT04699331
- Acronym / sponsor ID
- 2019-07-107
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Pusan National University Yangsan Hospital
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 7 Jan 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.
This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individualized stimulation group | Experimental | Device: Transcranial Direct Current StimulationPatients receive five sessions of individualized stimulation obtained from brain image-based transcranial direct stimulation simulation. The simulator generates the electrode's location on the scalp. |
| Conventional stimulation group | Active comparator | Device: Transcranial Direct Current StimulationPatients receive five sessions of conventional stimulation with electrodes over C3 and C4 based on the 10-20 system. |
| Sham stimulation group | Sham comparator | Device: Transcranial Direct Current StimulationPatients receive five sessions of sham stimulation with electrodes over C3 and C4 based on the 10-20 system. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral stroke patients
- Chronic patients over 6 months after onset
- Patients with motor evoked potential of the first dorsal interosseous muscle
- Patients with the movement of fingers
Key exclusion criteria (8 listed)
- History of psychiatric disease
- Significant other neurological diseases except for stroke
- Difficult to perform this experiment
- Patients who are deemed difficult to participate in this research by the investigator
- Patients with metal implants and medical devices
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 | Conventional stimulation group, Individualized stimulation group, Sham stimulation group |
Primary outcome
Changes in motor evoked potential
Time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Resting motor threshold (rMT), amplitude, and latency of motor evoked potential in the first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response. The latency is defined as the time point from the onset of the stimulus to the onset of MEP.
6 secondary outcomes
Jebsen-Taylor hand function test
Time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
9-hole peg test
Time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Grip & Tip pinch strength test
Time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Box & Block test
Time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Fugl-Meyer Assessment
Time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Sequential motor test
Time frame: Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions)
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 3 Feb 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 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 4 inclusion and 8 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 3 Feb 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 in motor evoked potential (time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)). 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 3 Feb 2023.