Clinical trial NCT03164798: Serum BDNF Role as a Biomarker for Stroke Rehabilitation
Official title: Serum BDNF Role as a Biomarker for Stroke Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Biomarker
Rehabilitation
BDNF
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subacute stroke patients who were received the comprehensive inpatients rehabilitation

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

Eligibility criteria: 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

Primary outcomes:
measure: Serum BDNF
timeFrame: At 2 weeks after the comprehensive inpatient rehabilitation
Secondary outcomes:
measure: Serum proBDNF
timeFrame: At 2 weeks after the comprehensive inpatient rehabilitation
measure: MMP-9
timeFrame: At 2 weeks after the comprehensive inpatient rehabilitation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Hyuk Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.