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White Matter Integrity According to BDNF Genotype After Stroke

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ClinicalTrials.gov Identifier: NCT03647787
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Study Description
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Brief Summary:
The aim of this study was to investigate differential plastic changes of fractional anisotropy (FA) in the corticospinal tract (CST), the intrahemispheric corticocortical tract from the primary motor cortex to ventral premotor cortex (M1PMv) and the corpus callosum (CC) from 2 weeks to 3 months after stroke according to BDNF genotype.

Condition or disease Intervention/treatment
Stroke Other: observational study

Detailed Description:
The aims of this study were to investigate plastic changes in the fractional anisotropy (FA) of three motor-related white matter fibers according to the BDNF genotype from 2 weeks to 3 months after stroke onset; one is a the majority of fibers from M1 to medullary oblongata (CST), another is the intrahemispheric connection from M1 to ventral premotor cortex (M1PMv), and the other is the interhemispheric connection between bilateral M1s (CC). There were also to investigate the relationships between motor impairment and tract-related FA of white matter tracts in each BDNF genotype

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Changes of White Matter Integrity According to BDNF Genotype During Motor Recovery After Stroke
Actual Study Start Date : December 1, 2009
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019
Groups and Cohorts
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Intervention Details:
  • Other: observational study
    This study is a longitudinal observational study

Outcome Measures
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Primary Outcome Measures :
  1. Fractional anisotropy [ Time Frame: 2 weeks to 3 months after stroke onset ]
    changes of fractional anisotropy (FA) in the corticospinal tract (CST)


Secondary Outcome Measures :
  1. Fractional anisotropy [ Time Frame: 2 weeks to 3 months after stroke onset ]
    changes of fractional anisotropy (FA) in the intrahemispheric corticocortical tract from the primary motor cortex to ventral premotor cortex (M1PMv)

  2. Fractional anisotropy [ Time Frame: 2 weeks to 3 months after stroke onset ]
    changes of fractional anisotropy (FA) in the corpus callosum (CC)


Biospecimen Retention:   Samples With DNA
brain-derived neurotrophic factor (BDNF) genotype single nucleotide polymorphism (SNP): a methionine (Met) substitution for valine (Val) at codon 66 (Val66Met; rs6265)

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ischemic stroke who were admitted to Samsung Medical Center and transferred to the Department of Physical and Rehabilitation Medicine
Criteria

Inclusion Criteria:

  • diagnosed with first-ever hemispheric ischemic infarction with damage to the supratentorial area confirmed by brain MRI within 2 weeks after stroke onset

Exclusion Criteria:

  • any clinically significant or unstable medical disorder or neuropsychiatric comorbidity
Contacts and Locations
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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): NCT03647787


Contacts
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Contact: Ahee Lee, MS 82-2-3410-2824 ahee.lee@gmail.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Gangnam-gu, Korea, Republic of, 06351
Contact: Yun-Hee Kim, MD, PhD    82-2-3410-2824    yun1225.kim@samsung.com   
Contact: Ahee Lee, MS    82-2-3410-2818    ahee.lee@gmail.com   
Sponsors and Collaborators
Samsung Medical Center
More Information
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03647787     History of Changes
Other Study ID Numbers: 2018-04-146
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases