Serum BDNF Role as a Biomarker for Stroke Rehabilitation

Stroke Clinical Trial

— BDNF  

Official title:

Serum BDNF Role as a Biomarker for Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164798
• Other study ID #: 2016-08-059
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BDNF
• Biomarker
• Rehabilitation
• Stroke

Intervention

Procedure:
• Conventional inpatient rehabilitation
comprehensive inpatient rehabilitation for 2 weeks

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Chang WH, Bang OY, Shin YI, Lee A, Pascual-Leone A, Kim YH. BDNF polymorphism and differential rTMS effects on motor recovery of stroke patients. Brain Stimul. 2014 Jul-Aug;7(4):553-8. doi: 10.1016/j.brs.2014.03.008. Epub 2014 Mar 26. — View Citation

Chang WH, Hwang JM, Uhm KE, Pascual-Leone A, Kim YH. Corticospinal excitability in the non-dominant hand is affected by BDNF genotype. Neurol Sci. 2017 Feb;38(2):241-247. doi: 10.1007/s10072-016-2749-9. Epub 2016 Oct 25. — View Citation

Hwang JM, Kim YH, Yoon KJ, Uhm KE, Chang WH. Different responses to facilitatory rTMS according to BDNF genotype. Clin Neurophysiol. 2015 Jul;126(7):1348-53. doi: 10.1016/j.clinph.2014.09.028. Epub 2014 Oct 12. — View Citation

Uhm KE, Kim YH, Yoon KJ, Hwang JM, Chang WH. BDNF genotype influence the efficacy of rTMS in stroke patients. Neurosci Lett. 2015 May 6;594:117-21. doi: 10.1016/j.neulet.2015.03.053. Epub 2015 Mar 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum BDNF	serum BDNF level	At 2 weeks after the comprehensive inpatient rehabilitation
Secondary	Serum proBDNF	Serum proBDNF level	At 2 weeks after the comprehensive inpatient rehabilitation
Secondary	MMP-9	MMP-9 level	At 2 weeks after the comprehensive inpatient rehabilitation