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Serum BDNF Role as a Biomarker for Stroke Rehabilitation

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03164798
Collaborator
(none)
150
Enrollment
1
Location
34.9
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Conventional inpatient rehabilitation

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 Design

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Serum BDNF Role as a Biomarker for Stroke Rehabilitation
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Aug 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Outcome Measures

Primary Outcome Measures

  1. Serum BDNF [At 2 weeks after the comprehensive inpatient rehabilitation]

    serum BDNF level

Secondary Outcome Measures

  1. Serum proBDNF [At 2 weeks after the comprehensive inpatient rehabilitation]

    Serum proBDNF level

  2. MMP-9 [At 2 weeks after the comprehensive inpatient rehabilitation]

    MMP-9 level

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 135-710

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Won Hyuk Chang, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT03164798
Other Study ID Numbers:
  • 2016-08-059
First Posted:
May 24, 2017
Last Update Posted:
Mar 18, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Mar 18, 2020