Serum BDNF Role as a Biomarker for Stroke Rehabilitation

Completed

• Conditions: Biomarker; BDNF; Stroke; Rehabilitation

• Registration Number: NCT03164798
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-05-21
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-24
• Primary Completion: 2019-08-31
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum BDNF	At 2 weeks after the comprehensive inpatient rehabilitation	serum BDNF level

Secondary Outcome Measures

Name	Time	Method
MMP-9	At 2 weeks after the comprehensive inpatient rehabilitation	MMP-9 level
Serum proBDNF	At 2 weeks after the comprehensive inpatient rehabilitation	Serum proBDNF level

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of