NCT03647787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

August 22, 2018

Last Update Submit

September 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fractional anisotropy

    changes of fractional anisotropy (FA) in the corticospinal tract (CST)

    2 weeks to 3 months after stroke onset

Secondary Outcomes (2)

  • Fractional anisotropy

    2 weeks to 3 months after stroke onset

  • Fractional anisotropy

    2 weeks to 3 months after stroke onset

Interventions

This study is a longitudinal observational study

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • any clinically significant or unstable medical disorder or neuropsychiatric comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

Related Publications (1)

  • 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.

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)

MeSH Terms

Conditions

Stroke

Interventions

Observation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 27, 2018

Study Start

May 25, 2018

Primary Completion

April 5, 2019

Study Completion

April 5, 2019

Last Updated

September 19, 2019

Record last verified: 2018-09

Locations