Clinical trial NCT06047223: Analysis of Brain Diffusion Tensor Image in Stroke Patients
Official title: Analysis of Brain Diffusion Tensor Image in Stroke Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke patients

Brief 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. To compare hematologic indicators and neurological function levels of stroke patients at the time of imaging examination with brain diffusion tensor imaging indicators.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 20 years or older with a history of stroke
2. 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

Exclusion Criteria:

Patients who meet one or more of the following cannot participate in the study.

1. 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
2. In the case of a person with impaired consent, a person without a guardian
3. 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
4. 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.)

Primary outcomes:
measure: Measurement of magnetic resonanace imaging (MRI)
timeFrame: Through study completion, an average of 1 day
Secondary outcomes:
measure: Measurement of Korean version of coma recovery scale-revised (K-CRSR)
timeFrame: Through study completion, an average of 1 day
measure: Measurement of Korean version of Montreal Cognitive Assessment (K-MoCA)
timeFrame: Through study completion, an average of 1 day
measure: Measurement of clinical dementia rate (CDR)
timeFrame: Through study completion, an average of 1 day
measure: Measurement of Korean version of oxford cognitive screen (OCS-K)
timeFrame: visit 1
measure: Measurement of digit span test.
timeFrame: Through study completion, an average of 1 day
measure: Measurement of digit span test.
timeFrame: Through study completion, an average of 1 day
measure: Measurement of Korean version of western aphasia battery (K-WAB)
timeFrame: Through study completion, an average of 1 day
measure: Measurement of motricity index (MI)
timeFrame: Through study completion, an average of 1 day
measure: Measurement of berg balance scale (BBS)
timeFrame: Through study completion, an average of 1 day
measure: Measurement of functional ambulatory category (FAC)
timeFrame: Through study completion, an average of 1 day
measure: Measurement of time up and go (TUG)
timeFrame: Through study completion, an average of 1 day
measure: Measurement of Fugl-Meyer assessment (FMA)
timeFrame: Through study completion, an average of 1 day
measure: Measurement of action research arm test (ARAT)
timeFrame: Through study completion, an average of 1 day
measure: Measurement of Korean version of modified barthel index (K-MBI)
timeFrame: Through study completion, an average of 1 day
measure: Measurement of motion analysis
timeFrame: Through study completion, an average of 1 day
measure: Measurement of motion analysis
timeFrame: Through study completion, an average of 1 day
measure: Measurement of motion analysis
timeFrame: Through study completion, an average of 1 day
measure: Measurement of motion analysis
timeFrame: Through study completion, an average of 1 day
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
affiliation: Bundang CHA Hospital
name: Minyoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: