Brain Imaging Study of Brain Plasticity in Chronic Stroke Patients

September 18, 2019 updated by: Samsung Medical Center

Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging Study About Reorganization and Recovery Mechanism of Brain Neural Network for Chronic Stroke Patients

In chronic stroke patients, brain network reorganization and recovery mechanism are investigated after stroke onset using functional MRI and diffusion tensor imaging analyses.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A person who was inpatient at subacute stage at the Samsung Medical Center.

Description

Inclusion Criteria:

  • more than 3 months post-stroke
  • ischemic or hemorrhagic stroke
  • a person who understands the experiment and has a willingness to participate and signs the agreement

Exclusion Criteria:

  • User of artificial heartbeat
  • Patients with claustrophobia
  • Patients with metal implants
  • Patients who are contraindicated for other common MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic stroke
More than 3 months post-stroke Ischemic or hemorrhagic stroke
Other: Chronic stroke
MRI data acquisition and behavioral test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation coefficient between strength of connection and the Fugl-Meyer Assessment score
Time Frame: Through study completion, an average of 1 year
Strength of connection is obtained by calculating a correlation coefficient between time courses of both regions in fMRI data.
Through study completion, an average of 1 year
Correlation coefficient between the FA value of a tract and the Fugl-Meyer Assessment score
Time Frame: Through study completion, an average of 1 year
FA value is obtained by assessing a diffusion anisotropy of a specific tract in DTI data.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 18, 2015

Primary Completion (ANTICIPATED)

June 18, 2020

Study Completion (ANTICIPATED)

June 18, 2020

Study Registration Dates

First Submitted

December 25, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (ACTUAL)

January 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-07-082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Stroke

Clinical Trials on Chronic stroke

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe