Serum BDNF Role as a Biomarker for Stroke Rehabilitation

NCT03164798 | Completed

• 1 other identifier: 2016-08-059
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Biomarker; Rehabilitation; BDNF

Outcome Measures

Primary Outcomes (1)

• Serum BDNF

  serum BDNF level

  At 2 weeks after the comprehensive inpatient rehabilitation

Secondary Outcomes (2)

• Serum proBDNF

  At 2 weeks after the comprehensive inpatient rehabilitation

• MMP-9

  At 2 weeks after the comprehensive inpatient rehabilitation

Interventions

Conventional inpatient rehabilitation PROCEDURE

comprehensive inpatient rehabilitation for 2 weeks

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subacute stroke patients who were received the comprehensive inpatients rehabilitation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related 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.

  PMID: 24767962 BACKGROUND

• 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.

  PMID: 25454277 BACKGROUND

• 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.

  PMID: 25817361 BACKGROUND

• 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.

  PMID: 27783184 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

BDNF Val66Met polymorphism

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Won Hyuk Chang, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: May 24, 2017
• Study Start: February 1, 2017
• Primary Completion: August 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)