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Recovery Prediction of Motor Function Using Neuroimaging Techniques in Subacute Stroke Patients

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ClinicalTrials.gov Identifier: NCT03365596
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Tracking Information
First Submitted Date November 27, 2017
First Posted Date December 7, 2017
Last Update Posted Date June 3, 2019
Actual Study Start Date June 1, 2017
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 3, 2017)
Fugl-Meyer Assessment score at 3 months after stroke onset [ Time Frame: 3 months after stroke onset ]
Measurement of motor function of upper and lower extremities
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03365596 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Recovery Prediction of Motor Function Using Neuroimaging Techniques in Subacute Stroke Patients
Official Title Functional MRI and DTI Study for Brain Network Analysis and Recovery Prediction in Subacute Stroke Patients
Brief Summary Prediction of recovery from stroke can assist in the planning of impairment-focused rehabilitation. To achieve better prediction for clinical purposes, this study investigated a new prediction model with low inter-individual variability and high accuracy using neuroimaging techniques.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population First-ever stroke patients at subacute stage.
Condition Stroke
Intervention Other: Conventional therapy
According to the status of a patient, optimized therapy will be applied.
Study Groups/Cohorts Subacute stroke
Intervention: Other: Conventional therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 30, 2019)
70
Original Estimated Enrollment
 (submitted: December 3, 2017)
50
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • First-ever stroke patients
  • Unilateral stroke
  • Subacute stage (less than 4 weeks)

Exclusion Criteria:

  • Major active neurological disease or psychiatric disease
  • A history of seizure
  • Metallic implants in their brain
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Yun-Hee Kim, MD, PhD +82-2-3410-2818 yun1225.kim@samsung.com
Contact: Jungsoo Lee, PhD +82-2-3410-3762 jungsoo0319@gmail.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03365596
Other Study ID Numbers 2017-02-107
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Samsung Medical Center
Study Sponsor Samsung Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Samsung Medical Center
Verification Date June 2018