StrokeNCT06047223
Analysis of Brain Diffusion Tensor Image in Stroke Patients
An observational study of Stroke, run by Bundang CHA Hospital at 1 site in South Korea.
Trial summary
This clinical study aims to confirm the characteristics of the functional ansiotropy value according to the individual characteristics of stroke patients by taking brain diffusion tensor images for stroke patients and using the MRI. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Magnetic resonanace imaging
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Oct 2023to 31 Dec 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- Adults aged 20 years or older with a history of stroke
- After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions
Who cannot join
- Patients who meet one or more of the following cannot participate in the study.
- Those with severe medical conditions such as unstable conditions in the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with poor general health
- In the case of a person with impaired consent, a person without a guardian
- Patients who have devices that may be affected by MRI, such as pacemakers, spinal cord stimulators, cochlear implants, VP shunts, and nerve stimulators, inserted into the body
- Other cases where the researcher judges that participation in this study is not suitable (This study is not an interventional study, and patients who are participating in other clinical trials or studies or who have participated in other clinical trials or studies within the past 30 days can also participate in this study.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 463-712
Minyoung Kim, M.D., Ph.D., 82-31-780-1872, kmin@cha.ac.kr
Seyoung Shin, M.D., 82-31-780-6003, seyoung0706@chamc.co.kr
About this study
This clinical study aims to confirm the characteristics of the functional ansiotropy value according to the individual characteristics of stroke patients by taking brain diffusion tensor images for stroke patients and using the MRI. To compare hematologic indicators and neurological function levels of stroke patients at the time of imaging examination with brain diffusion tensor imaging indicators.
- Conditions
- Stroke
- Being tested
- Magnetic resonanace imaging
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonanace imagingDiagnostic test
Magnetic resonance imaging for measurement of diffustion tensor imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of magnetic resonanace imaging (MRI)
MRI scan is a process of measuring changes of diffusion tensor tractography
Measured: Through study completion, an average of 1 day
Secondary outcomes (18)
Measurement of Korean version of coma recovery scale-revised (K-CRSR)
K-CRSR is Korean version of standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. he scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness.
Measured: Through study completion, an average of 1 day
Measurement of Korean version of Montreal Cognitive Assessment (K-MoCA)
K-MoCA is a measurement to evaluate the memory loss or other symptoms of cognitive decline. It contains 30 questions and taskes around to 12 minutes to complete. Scores range from 0 to 30. A score of 26 and higher is considered normal.
Measured: Through study completion, an average of 1 day
Measurement of clinical dementia rate (CDR)
CDR is a rating scale for staging patients diagnosed with dementia. The CDR evaluates cognitive, behavioral and functional aspects of Alzheimer disease and other dementias. It is calculated on the basis of testing six different cognitive and behavioral domains such as memory, orientation, judgment and problem sloving, community affairs, home and hobbies performance, and personal care. The CDR is based on a scale of 0-3: no dementia (CDR = 0), questionable dementia (CDR = 0.5), MCI (CDR = 1), moderate cognitive impairment (CDR = 2) and severe cognitive impairment (CDR = 3)
Measured: Through study completion, an average of 1 day
Measurement of Korean version of oxford cognitive screen (OCS-K)
OCS is an assessment of major cognitive domains of memory, language, number, praxis, executive functions and attention.
Measured: visit 1
Measurement of digit span test.
Digit span test is a measurment to assess the storage capacity of a person's working memory. A testperson is visually or auditorily to a sequence of digits on after another. Right afterwards, the test subject has to recall the correct digits in the same order.
Measured: Through study completion, an average of 1 day
Measurement of digit span test.
inhibit cognitie interference. The stroop test consists of colors that are writen in words but in the wrong color ink, The test-taker has to be able to state the color that the word is written in and be able to ignore whatever the actual word is.
Measured: Through study completion, an average of 1 day
Measurement of Korean version of western aphasia battery (K-WAB)
K-WAB is designed as an assessment tool to examine linguistic skills (information content, fluency, auditory comprehension, repetition, naming and word finding, reading, and writing) and main nonlinguistic skills (drawing, block design, calculation, and praxis) of adults with aphasia.
Measured: Through study completion, an average of 1 day
Measurement of motricity index (MI)
MI is a process of the evaluating the function and strength of upper, lower extremities and trunk in score.
Measured: Through study completion, an average of 1 day
Measurement of berg balance scale (BBS)
BBS is a measurement of balancing function. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total score = 56
Measured: Through study completion, an average of 1 day
Measurement of functional ambulatory category (FAC)
FAC is a measurement of a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use personal assistive device.
Measured: Through study completion, an average of 1 day
Measurement of time up and go (TUG)
TUG is a measurement of a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. 11-20 seconds are within normal limits for frail elderly and disables patients, and greater than 20 seconds means the person needs assistance outside and indicates further examintaiton and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
Measured: Through study completion, an average of 1 day
Measurement of Fugl-Meyer assessment (FMA)
FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sesation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research determine disease severity, describe motor recovery, and to plan and assess treatment.
Measured: Through study completion, an average of 1 day
Measurement of action research arm test (ARAT)
ARAT is a 19 item observational measurement to assess upper extremity performance (coordination, dexterity and functioning). Items comprising ARAT are categorized into four subscales (grasp, grip, pinch and gross movement). Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performend normally)
Measured: Through study completion, an average of 1 day
Measurement of Korean version of modified barthel index (K-MBI)
MBI is a measurement of degree of independence of a patient from any assistance. It covers 10 domains of daily activities: bowel and bladder control, grooming, toilet use, feeding, trasnfers, walking, dressing, climbing stairs and bathing
Measured: Through study completion, an average of 1 day
Measurement of motion analysis
Motion analysis is a process of measuring and evaluating gait function in kinetic parameters of range of motion in angle of each joint by degree throguh Qualisys motion analysis system
Measured: Through study completion, an average of 1 day
Measurement of motion analysis
Motion analysis is a process of measuring and evaluating gait function and kinematic parameters including moment (Nm/kg) of each joint throguh Qualisys motion analysis system
Measured: Through study completion, an average of 1 day
Measurement of motion analysis
Motion analysis is a process of measuring and evaluating gait function and kinematic parameters including power (Nm/s*kg) of each joint throguh Qualisys motion analysis system
Measured: Through study completion, an average of 1 day
Measurement of motion analysis
Motion analysis is a process of measuring and evaluating gait function and kinematic parameters including ground reaction force (N/kg) of each joint throguh Qualisys motion analysis system
Measured: Through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start5 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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.
- 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
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MinYoung Kim, MD, PhD, Bundang CHA Hospital
- Investigators
- Minyoung Kim, M.D., Ph.D., Principal investigator, Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047223
- Sponsor's protocol ID
- 2023-08-005
- Status last verified
- Nov 2023
- First submitted
- 28 Aug 2023
- Last updated
- 18 Nov 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Brain Diffusion Tensor Image in Stroke Patients
- ClinicalTrials.gov ID
- NCT06047223
- Acronym / sponsor ID
- 2023-08-005
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Sep 2023 (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 clinical study aims to confirm the characteristics of the functional ansiotropy value according to the individual characteristics of stroke patients by taking brain diffusion tensor images for stroke patients and using the MRI. To compare hematologic indicators and neurological function levels of stroke patients at the time of imaging examination with brain diffusion tensor imaging indicators.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (2 listed)
- Adults aged 20 years or older with a history of stroke
- After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions
Key exclusion criteria (5 listed)
- Patients who meet one or more of the following cannot participate in the study.
- Those with severe medical conditions such as unstable conditions in the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with poor general health
- In the case of a person with impaired consent, a person without a guardian
- Patients who have devices that may be affected by MRI, such as pacemakers, spinal cord stimulators, cochlear implants, VP shunts, and nerve stimulators, inserted into the body
- Other cases where the researcher judges that participation in this study is not suitable (This study is not an interventional study, and patients who are participating in other clinical trials or studies or who have participated in other clinical trials or studies within the past 30 days can also participate in this study.)
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 |
|---|---|---|
| Magnetic resonanace imagingMagnetic resonance imaging for measurement of diffustion tensor imaging | Diagnostic test | – |
Primary outcome
Measurement of magnetic resonanace imaging (MRI)
Time frame: Through study completion, an average of 1 day
MRI scan is a process of measuring changes of diffusion tensor tractography
18 secondary outcomes
Measurement of Korean version of coma recovery scale-revised (K-CRSR)
Time frame: Through study completion, an average of 1 day
Measurement of Korean version of Montreal Cognitive Assessment (K-MoCA)
Time frame: Through study completion, an average of 1 day
Measurement of clinical dementia rate (CDR)
Time frame: Through study completion, an average of 1 day
Measurement of Korean version of oxford cognitive screen (OCS-K)
Time frame: visit 1
Measurement of digit span test.
Time frame: Through study completion, an average of 1 day
Measurement of digit span test.
Time frame: Through study completion, an average of 1 day
Measurement of Korean version of western aphasia battery (K-WAB)
Time frame: Through study completion, an average of 1 day
Measurement of motricity index (MI)
Time frame: Through study completion, an average of 1 day
Measurement of berg balance scale (BBS)
Time frame: Through study completion, an average of 1 day
Measurement of functional ambulatory category (FAC)
Time frame: Through study completion, an average of 1 day
Measurement of time up and go (TUG)
Time frame: Through study completion, an average of 1 day
Measurement of Fugl-Meyer assessment (FMA)
Time frame: Through study completion, an average of 1 day
Measurement of action research arm test (ARAT)
Time frame: Through study completion, an average of 1 day
Measurement of Korean version of modified barthel index (K-MBI)
Time frame: Through study completion, an average of 1 day
Measurement of motion analysis
Time frame: Through study completion, an average of 1 day
Measurement of motion analysis
Time frame: Through study completion, an average of 1 day
Measurement of motion analysis
Time frame: Through study completion, an average of 1 day
Measurement of motion analysis
Time frame: Through study completion, an average of 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
Minyoung Kim, M.D., Ph.D. principal investigator
Bundang CHA Hospital
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 Stroke, run by Bundang CHA Hospital 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 2 inclusion and 5 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 18 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Jung Oh, BS (+82 031 780 6003 ext. 6003, a210525@chamc.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of magnetic resonanace imaging (MRI) (time frame: Through study completion, an average of 1 day). 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 18 Nov 2023.