Serum BDNF Role as a Biomarker for Stroke Rehabilitation (BDNF)

March 16, 2020 updated by: Won Hyuk Chang, Samsung Medical Center
This study aims to develop the quantitative biomarker to establish the individualized strategy in stroke rehabilitation. Brain-derived neurotrophic factor (BDNF) acts on certain neurons of the central nervous system (CNS) helping to support the survival of existing neurons, and encourage the growth and differentiation of new neurons and synapses. BDNF in CNS can be assessed by analysing serum BDNF. The final objective of this study is to demonstrate a role of biomarker of BDNF in stroke rehabilitation to establish the individualized strategy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Serum BDNF, proBDNF and MMP-9 in all participants will be measured before and after the comprehensive inpatient rehabilitation during subacute stroke phase. At 3 months after stroke onset, serum BDNF, proBDNF and MMP-9 will also be measured.

In addition, motor impairment with Fugl-Meyer assessement will be assessed at same time points with serum analysis.

We will compare potential serum biomarkers with motor impairment in stroke patients

Study Type

Observational

Enrollment (Actual)

150

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

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Subacute stroke patients who were received the comprehensive inpatients rehabilitation

Description

Inclusion Criteria:

  • unilateral stroke patients
  • admission to the rehabilitation department before 1 month after stroke onset
  • mild to severe motor impairment at time of transferring to the rehabilitation department

Exclusion Criteria:

  • Progressive or unstable stroke
  • Pre-existing and active major neurological disease
  • Pre-existing and active major psychiatric disease
  • Advanced liver, kidney, cardiac, or pulmonary disease
  • A terminal medical diagnosis consistent with survival < 1 year)
  • Pregnant or lactating woman

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum BDNF
Time Frame: At 2 weeks after the comprehensive inpatient rehabilitation
serum BDNF level
At 2 weeks after the comprehensive inpatient rehabilitation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum proBDNF
Time Frame: At 2 weeks after the comprehensive inpatient rehabilitation
Serum proBDNF level
At 2 weeks after the comprehensive inpatient rehabilitation
MMP-9
Time Frame: At 2 weeks after the comprehensive inpatient rehabilitation
MMP-9 level
At 2 weeks after the comprehensive inpatient rehabilitation

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Won Hyuk Chang, MD, PhD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2017

Primary Completion (ACTUAL)

August 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

May 21, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (ACTUAL)

May 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-08-059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make IPD available to other researchers.

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.

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