StrokeNCT04830631
tDCS Response Prediction Using EEG in Stroke
An observational study of Stroke and Rehabilitation, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Patients with chronic stroke (>6 months after stroke) having unilateral upper limb hemiparesis will be recruited. Patients will maintain their usual inpatient rehabilitation including occupational therapy. At baseline (T0) and after 2weeks of enrollment (T1), Fugl-Meyer assessment (FMA) will be assessed at each time. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Stroke, Rehabilitation, Transcranial Direct Current Stimulation
- What is being tested?
- Cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Jul 2020to Mar 2024
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic stroke patients with unilateral hemiparesis
Who may be able to join
- age ranges from 19 to 85 yrs old
- stroke patients with unilateral hemiparesis
- 1st ever stroke
- chronic stroke (>6 months after stroke)
Who cannot join
- recurrent stroke
- history of traumatic brain injury
- Minimental state examination score is 15 or less.
- Unstable medical conditions
- Severe delirium, disorders of consciousness
- pregnancy
Show all 9Show fewer
- can not attach tDCS electrode on the scalp due to skin conditions
- can not maintain the sitting position
- intracranial metals
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Won-Seok Kim, 0317877735, wondol77@gmail.com
Won-Seok Kim, MD
- Recruiting
Rusk Rehabilitation Hospital
Seongnam-si, Please Select, 13620
Chaiyoung Lim, MD
Chaiyoung Lim, MD
About this study
Official title: Prediction of Transcranial Direct Current Stimulation (tDCS) Responses Using Electroencephalography (EEG )in Patients With Chronic Stroke
Patients with chronic stroke (>6 months after stroke) having unilateral upper limb hemiparesis will be recruited. Patients will maintain their usual inpatient rehabilitation including occupational therapy. At baseline (T0) and after 2weeks of enrollment (T1), Fugl-Meyer assessment (FMA) will be assessed at each time. And patients with the changes of FMA between T0 and T1 less than 3 points will be finally recruited. The enrolled patients will receive additional 30-min cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex for 10 consecutive weekdays, with maintaining their usual conventional rehabilitation. At T1 and immediately after 10-seessions of tDCS (T2) and 1 month after completing 10-tDCS session (T3), FMA, Actional Research Arm Test (ARAT), Box and Block Test (BBT) and electroencephalography (EEG) were measured.
- Being tested
- Cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortexDevice
Cathodal tDCS will be applied to the contralesional motor cortex with 2mA intesntisy for 30 mins/day. Total 10 sessions will be applied.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fugl-Meyer Assesment Score 1
Measured: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Secondary outcomes (7)
Changes in Fugl-Meyer Assesment Score 2
Measured: Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
Changes in Action Research Arm Test Score 1
Measured: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Changes in Action Research Arm Test Score 2
Measured: Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
Changes in Box and Block Test Score 1
Measured: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Changes in Box and Block Test Score 2
Measured: Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
Changes in EEG index1
Various kinds of EEG indexe.g., network indexes, event-related dysynchronization, mu suppression) will be surveyed.
Measured: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Changes in EEG index 2
Various kinds of EEG indexe.g., network indexes, event-related dysynchronization, mu suppression) will be surveyed.
Measured: Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Jul 2020
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
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 Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rusk Rehabilitation Hospital
- Responsible party
- Principal investigator, Won-Seok Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830631
- Sponsor's protocol ID
- B-2004/608-004
- Status last verified
- May 2022
- First submitted
- 31 Mar 2021
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After completing the study, EEG indexes and behavioral outcomes will be considered to be shared with researchers who have the clear and reasonable purpose to use our data.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Transcranial Direct Current Stimulation (tDCS) Responses Using Electroencephalography (EEG )in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04830631
- Acronym / sponsor ID
- B-2004/608-004
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Rusk Rehabilitation Hospital
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 5 Apr 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.
Patients with chronic stroke (>6 months after stroke) having unilateral upper limb hemiparesis will be recruited. Patients will maintain their usual inpatient rehabilitation including occupational therapy. At baseline (T0) and after 2weeks of enrollment (T1), Fugl-Meyer assessment (FMA) will be assessed at each time. And patients with the changes of FMA between T0 and T1 less than 3 points will be finally recruited. The enrolled patients will receive additional 30-min cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex for 10 consecutive weekdays, with maintaining their usual conventional rehabilitation. At T1 and immediately after 10-seessions of tDCS (T2) and 1 month after completing 10-tDCS session (T3), FMA, Actional Research Arm Test (ARAT), Box and Block Test (BBT) and electroencephalography (EEG) were measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic stroke patients with unilateral hemiparesis
Key inclusion criteria (4 listed)
- age ranges from 19 to 85 yrs old
- stroke patients with unilateral hemiparesis
- 1st ever stroke
- chronic stroke (>6 months after stroke)
Key exclusion criteria (9 listed)
- recurrent stroke
- history of traumatic brain injury
- Minimental state examination score is 15 or less.
- Unstable medical conditions
- Severe delirium, disorders of consciousness
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 |
|---|---|---|
| Cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortexCathodal tDCS will be applied to the contralesional motor cortex with 2mA intesntisy for 30 mins/day. Total 10 sessions will be applied. | Device | – |
Primary outcome
Changes in Fugl-Meyer Assesment Score 1
Time frame: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
7 secondary outcomes
Changes in Fugl-Meyer Assesment Score 2
Time frame: Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
Changes in Action Research Arm Test Score 1
Time frame: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Changes in Action Research Arm Test Score 2
Time frame: Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
Changes in Box and Block Test Score 1
Time frame: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Changes in Box and Block Test Score 2
Time frame: Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
Changes in EEG index1
Time frame: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Changes in EEG index 2
Time frame: Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: Undecided. After completing the study, EEG indexes and behavioral outcomes will be considered to be shared with researchers who have the clear and reasonable purpose to use our data.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Rehabilitation, run by Seoul National University Hospital at 2 sites 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 9 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: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Won-Seok Kim (+82317877735, wondol77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fugl-Meyer Assesment Score 1 (time frame: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)). 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 17 May 2022.