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Completed

NCT Number: NCT03164798

Serum BDNF Role as a Biomarker for Stroke Rehabilitation

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.

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Key information

Conditions

Stroke BDNF Biomarker Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Rehabilitation Vascular Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional inpatient rehabilitation

Procedure

comprehensive inpatient rehabilitation for 2 weeks

Primary outcomes

  1. Serum BDNF

    Time frame: At 2 weeks after the comprehensive inpatient rehabilitation

    serum BDNF level

Secondary outcomes

  1. Serum proBDNF

    Time frame: At 2 weeks after the comprehensive inpatient rehabilitation

    Serum proBDNF level

  2. MMP-9

    Time frame: At 2 weeks after the comprehensive inpatient rehabilitation

    MMP-9 level

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Acronym: BDNF

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 24, 2017
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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