White Matter Integrity According to BDNF Genotype After S... | NCT03647787

Studies
White Matter Integrity According to BDNF Genotype After Stroke

NCT03647787

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Sep 19, 2019Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Stroke

Interventions

observational study

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2018Actual

Primary Completion Date

Apr 5, 2019Actual

Completion Date

Apr 5, 2019Actual

First Submitted Date

Aug 22, 2018

First Submission Date that Met QC Criteria

Aug 23, 2018

First Posted Date

Aug 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2019

Last Update Posted Date

Sep 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observational study	Other	This study is a longitudinal observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fractional anisotropy	changes of fractional anisotropy (FA) in the corticospinal tract (CST)	2 weeks to 3 months after stroke onset

Secondary Outcomes

Measure	Description	Time Frame
Fractional anisotropy	changes of fractional anisotropy (FA) in the intrahemispheric corticocortical tract from the primary motor cortex to ventral premotor cortex (M1PMv)	2 weeks to 3 months after stroke onset
Fractional anisotropy

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with ischemic stroke who were admitted to Samsung Medical Center and transferred to the Department of Physical and Rehabilitation Medicine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul	Gangnam-gu	06351	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33029116	Derived	Park E, Lee J, Chang WH, Lee A, Hummel FC, Kim YH. Differential Relationship between Microstructural Integrity in White Matter Tracts and Motor Recovery following Stroke Based on Brain-Derived Neurotrophic Factor Genotype. Neural Plast. 2020 Sep 22;2020:5742421. doi: 10.1155/2020/5742421. eCollection 2020.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D008722	Methods
D008919	Investigative Techniques