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Predicting Language Outcome after Stroke Based on Machine Learning Using Multivariate Biomarkers of Brain Lesion

Status Approved

First Submitted Date

2021/03/29
Registered Date

2021/03/31
Last Updated Date

2021/03/29

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006047
Unique Protocol ID	2019AN0231
Public/Brief Title	Predicting Language Outcome after Stroke Based on Machine Learning Using Multivariate Biomarkers of Brain Lesion
Scientific Title	Predicting Language Outcome after Stroke Based on Machine Learning Using Multivariate Biomarkers of Brain Lesion
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2019AN0231
Approval Date	2019-06-11
Institutional Review Board Name	Korea university anam hospital clinical trial center
Institutional Review Board Address	73, Inchon-ro, Seongbuk-gu, Seoul
Institutional Review Board Telephone	02-920-6566
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Sung-Bom Pyun
Title	Professor
Telephone	+82-2-920-6471
Affiliation	Korea University Anam Hospital
Address	73, Goryeodae-ro, Seongbuk-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	Sung-Bom Pyun
Title	Professor
Telephone	+82-2-920-6471
Affiliation	Korea University Anam Hospital
Address	73, Goryeodae-ro, Seongbuk-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	Sung-Bom Pyun
Title	Professor
Telephone	+82-2-920-6471
Affiliation	Korea University Anam Hospital
Address	73, Goryeodae-ro, Seongbuk-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-06-11 Actual
Target Number of Participant	500
Primary Completion Date	2022-06-30 , Anticipated
Study Completion Date	2022-06-30 , Anticipated
Name of Study	Korea University Anam Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-06-11 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Research Foundation
Organization Type	Government
Project ID	2019R1A2C2003020

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea University Anam Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This study aims to implement a functional recovery prediction model after stroke using multivariate brain lesion biomarkers to track the short-term and long-term recovery of speech function after stroke For this, structural and functional brain images are collected and analyzed for damage-symptom mapping (voxel-based lesion-symptom mapping, VLSM), diffusion tensor tractography (DTT), resting state fMRI. , rs-fMRI), to extract key predictors of brain neurological recovery of speech function. Based on the analyzed brain structure and brain function multivariate brain damage biomarkers, different prognostic factors such as demographic, neurological, and cognitive factors are combined to determine the language after stroke according to each recovery period (acute, subacute, chronic). The ultimate goal is to implement a functional recovery prediction model.

Study Summary Information

Lay Summary

This study aims to implement a functional recovery prediction model after stroke using multivariate brain lesion biomarkers to track the short-term and long-term recovery of speech function after stroke
For this, structural and functional brain images are collected and analyzed for damage-symptom mapping (voxel-based lesion-symptom mapping, VLSM), diffusion tensor tractography (DTT), resting state fMRI. , rs-fMRI), to extract key predictors of brain neurological recovery of speech function.
Based on the analyzed brain structure and brain function multivariate brain damage biomarkers, different prognostic factors such as demographic, neurological, and cognitive factors are combined to determine the language after stroke according to each recovery period (acute, subacute, chronic). The ultimate goal is to implement a functional recovery prediction model.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Prospective
Target Number of Participant	500
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Stroke patients and normal adult control group
Cohort/ Group 1	Cohort/Group Description Stroke patients) Patients with speech, cognitive, and motor disorders after diagnosis of stroke Normal adult control group) Those with no impairment in cognitive, language, and motor function, the same gender as the patient group, and similar age Brain magnetic resonance imaging and clinical evaluation were performed in the above patient group and control group.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Stroke patients and normal adult controls who visited the Department of Rehabilitation Medicine at Korea University Anam Hospital
Sampling Method	Those who agreed to the study among stroke patients and normal adult control groups who visited the Department of Rehabilitation Medicine at Korea University Anam Hospital
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I64)Stroke, not specified as haemorrhage or infarction Stroke
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description Stroke patients) Patients with speech, cognitive, and motor disorders after diagnosis of stroke Normal adult control group) Those with no impairment in cognitive, language, and motor function, the same gender as the patient group, and similar age
Exclusion Criteria	A. In case of disqualification for MRI -There should not be any metal material (orthodontic braces, implants that cannot be removed or metal- pacemakers, screws- in the body due to accidents or surgery). Caries treatment is okay. -Those who have no brain damage, brain history, or neurological disease (normal control only) -People with claustrophobia B. Patient exclusion criteria -Patients with neurological or psychiatric diseases prior to onset of stroke -Patients with unstable vital signs or difficult to maintain rehabilitation treatment due to medical conditions -Patients with difficulty in language evaluation because their language is not Korean -Patients who cannot evaluate motor function (patients who already have proximal drugs due to past amputation or nerve damage
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Brain structure and functional MRI
Timepoint	Immediately after onset and 6 months after onset
Secondary Outcome(s) 1
Outcome	Motor function, cognitive function, language function
Timepoint	Immediately after onset and 6 months after onset

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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