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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 : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

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.

Condition or disease Intervention/treatment
Stroke Other: Conventional therapy

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Functional MRI and DTI Study for Brain Network Analysis and Recovery Prediction in Subacute Stroke Patients
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Group/Cohort Intervention/treatment
Subacute stroke Other: Conventional therapy
According to the status of a patient, optimized therapy will be applied.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
First-ever stroke patients at subacute stage.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365596


Contacts
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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

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Yun-Hee Kim, MD, PhD    82-2-3410-2824    yunkim@skku.edu   
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03365596     History of Changes
Other Study ID Numbers: 2017-02-107
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samsung Medical Center:
Brain connectivity
Magnetic resonance imaging
Recovery prediction
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases