StrokeBDNFNCT03164798
Serum BDNF Role as a Biomarker for Stroke Rehabilitation
An observational study of Stroke and Biomarker, run by Samsung Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Stroke, Biomarker, Rehabilitation
- What is being tested?
- Conventional inpatient rehabilitation
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subacute stroke patients who were received the comprehensive inpatients rehabilitation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Stroke, Biomarker, Rehabilitation, BDNF
- Being tested
- Conventional inpatient rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional inpatient rehabilitationProcedure or surgery
comprehensive inpatient rehabilitation for 2 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum BDNF
serum BDNF level
Measured: At 2 weeks after the comprehensive inpatient rehabilitation
Secondary outcomes (2)
Serum proBDNF
Serum proBDNF level
Measured: At 2 weeks after the comprehensive inpatient rehabilitation
MMP-9
MMP-9 level
Measured: At 2 weeks after the comprehensive inpatient rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Feb 2017
- Primary completion31 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Hyuk Chang, Samsung Medical Center
- Investigators
- Won Hyuk Chang, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164798
- Sponsor's protocol ID
- 2016-08-059
- Acronym
- BDNF
- Status last verified
- Mar 2020
- First submitted
- 21 May 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Publications
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.
PubMed 24767962Hwang 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.
PubMed 25454277Uhm 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.
PubMed 25817361Chang 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.
PubMed 27783184
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum BDNF Role as a Biomarker for Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT03164798
- Acronym / sponsor ID
- BDNF / 2016-08-059
- Conditions
- Stroke, Biomarker, Rehabilitation, BDNF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subacute stroke patients who were received the comprehensive inpatients rehabilitation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional inpatient rehabilitationcomprehensive inpatient rehabilitation for 2 weeks | Procedure or surgery | – |
Primary outcome
Serum BDNF
Time frame: At 2 weeks after the comprehensive inpatient rehabilitation
serum BDNF level
2 secondary outcomes
Serum proBDNF
Time frame: At 2 weeks after the comprehensive inpatient rehabilitation
MMP-9
Time frame: At 2 weeks after the comprehensive inpatient rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 24767962Chang 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.
- Background: PubMed 25454277Hwang 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.
- Background: PubMed 25817361Uhm 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.
- Background: PubMed 27783184Chang 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.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Hyuk Chang, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Biomarker, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum BDNF (time frame: At 2 weeks after the comprehensive inpatient rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03164798, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.