Chronic StrokeNCT03392519
Brain Imaging Study of Brain Plasticity in Chronic Stroke Patients
An observational study of Chronic Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In chronic stroke patients, brain network reorganization and recovery mechanism are investigated after stroke onset using functional MRI and diffusion tensor imaging analyses. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Chronic stroke
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Aug 2015to 17 Jul 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A person who was inpatient at subacute stage at the Samsung Medical Center.
Who may be able to join
- more than 3 months post-stroke
- ischemic or hemorrhagic stroke
- a person who understands the experiment and has a willingness to participate and signs the agreement
Who cannot join
- User of artificial heartbeat
- Patients with claustrophobia
- Patients with metal implants
- Patients who are contraindicated for other common MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging Study About Reorganization and Recovery Mechanism of Brain Neural Network for Chronic Stroke Patients
In chronic stroke patients, brain network reorganization and recovery mechanism are investigated after stroke onset using functional MRI and diffusion tensor imaging analyses.
- Conditions
- Chronic Stroke
- Being tested
- Chronic stroke
- Keywords
- Brain connectivity, Magnetic resonance imaging, Brain plasticity, Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic strokeOther
MRI data acquisition and behavioral test
| Study group | Role | What they receive |
|---|---|---|
| Chronic stroke | More than 3 months post-stroke Ischemic or hemorrhagic stroke Receives: Other: Chronic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between strength of connection and the Fugl-Meyer Assessment score
Strength of connection is obtained by calculating a correlation coefficient between time courses of both regions in fMRI data.
Measured: Through study completion, an average of 1 year
Correlation coefficient between the FA value of a tract and the Fugl-Meyer Assessment score
FA value is obtained by assessing a diffusion anisotropy of a specific tract in DTI data.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start18 Aug 2015
- Primary completion30 Jun 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 59 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
- NCT03392519
- Sponsor's protocol ID
- 2015-07-082
- Status last verified
- Sep 2019
- First submitted
- 25 Dec 2017
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging Study About Reorganization and Recovery Mechanism of Brain Neural Network for Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT03392519
- Acronym / sponsor ID
- 2015-07-082
- Conditions
- Chronic Stroke
- Keywords
- Brain connectivity, Magnetic resonance imaging, Brain plasticity, Recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 18 Aug 2015 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 8 Jan 2018 (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.
In chronic stroke patients, brain network reorganization and recovery mechanism are investigated after stroke onset using functional MRI and diffusion tensor imaging analyses.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic stroke | – | Other: Chronic strokeMore than 3 months post-stroke Ischemic or hemorrhagic stroke |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A person who was inpatient at subacute stage at the Samsung Medical Center.
Key inclusion criteria (3 listed)
- more than 3 months post-stroke
- ischemic or hemorrhagic stroke
- a person who understands the experiment and has a willingness to participate and signs the agreement
Key exclusion criteria (4 listed)
- User of artificial heartbeat
- Patients with claustrophobia
- Patients with metal implants
- Patients who are contraindicated for other common MRI
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 |
|---|---|---|
| Chronic strokeMRI data acquisition and behavioral test | Other | Chronic stroke |
Primary outcome
Correlation coefficient between strength of connection and the Fugl-Meyer Assessment score
Time frame: Through study completion, an average of 1 year
Strength of connection is obtained by calculating a correlation coefficient between time courses of both regions in fMRI data.
Correlation coefficient between the FA value of a tract and the Fugl-Meyer Assessment score
Time frame: Through study completion, an average of 1 year
FA value is obtained by assessing a diffusion anisotropy of a specific tract in DTI data.
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 8 Mar 2023.
- Individual participant dataSharing planned: No
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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?
An observational study of Chronic 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 4 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 8 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. 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?
Correlation coefficient between strength of connection and the Fugl-Meyer Assessment score (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 8 Mar 2023.