Ischemic StrokeBDNFNCT02860260
Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke
A study testing Blood samples and Cerebral MRI in people with Ischemic Stroke, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim of this study is to show for the first time that treatment with intravenous fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Blood samples and Cerebral MRI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Jan 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (or their person of trust in cases of inability) who have been informed about the research and given their consent to take part
- Patients aged 18 years or older
- Patients who have suffered a de novo recent ischemic stroke < 12 hours
- Patients who had cerebral imaging (CT-Scan or MRI)
- Ischemic stroke severity, measured by the National Institute of Health Stroke Score (NIHSS), between 4 and 20
Who cannot join
- Patients without national health insurance cover
- Patients with a clinical history of stroke
- Patients with cerebral or sub-arachnoid haemorrhage
- Patients with a transient ischemic attack
- Time of symptom onset unknown
- Patients with severe aphasia at the time of the ischemic stroke defined by a sub-score for item 9 (best language) of the NIHSS ≥ 2
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- Patients with dementia prior to the ischemic stroke
- Patients with a significant loss of autonomy prior to the ischemic stroke, defined by a Rankin score ≥ 4
- Patients with aphasia before the ischemic stroke
- Patients with a contra-indication for cerebral MRI
- Pregnant or breast-feeding women
- Adults under guardianship
- Subjects in custody
- Patients who do not speak French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke: Effect of Intravenous Fibrinolysis With Rt-PA
The aim of this study is to show for the first time that treatment with intravenous fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain.
The analysis of the recovery of functional and cognitive abilities as well as mood at 3 months will allow us to study the impact of BDNF on these parameters. Thus, depending on the results obtained, circulating BDNF could serve as an early marker of these.
- Conditions
- Ischemic Stroke
- Being tested
- Blood samples, Cerebral MRI
- Keywords
- BDNF
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
Cerebral MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with fibrinolysis | Experimental | Not described Receives: Biological: Blood samples; Other: Cerebral MRI |
| Patients without fibrinolysis | Placebo comparator | Not described Receives: Biological: Blood samples; Other: Cerebral MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of plasma levels of BDNF
Measured: Change from baseline at Day1, Day 7 and Month 3
Measurement of serum levels of BDNF
Measured: Change from baseline at Day1, Day 7 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860260
- Sponsor's protocol ID
- BEJOT
- Acronym
- BDNF
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2016
- Last updated
- 12 Mar 2026
- Results posted
- No
Publications
Rodier M, Quirie A, Prigent-Tessier A, Bejot Y, Jacquin A, Mossiat C, Marie C, Garnier P. Relevance of Post-Stroke Circulating BDNF Levels as a Prognostic Biomarker of Stroke Outcome. Impact of rt-PA Treatment. PLoS One. 2015 Oct 15;10(10):e0140668. doi: 10.1371/journal.pone.0140668. eCollection 2015.
PubMed 26469350
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke: Effect of Intravenous Fibrinolysis With Rt-PA
- ClinicalTrials.gov ID
- NCT02860260
- Acronym / sponsor ID
- BDNF / BEJOT
- Conditions
- Ischemic Stroke
- Keywords
- BDNF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- First posted
- 9 Aug 2016 (estimated)
- 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.
The aim of this study is to show for the first time that treatment with intravenous fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain.
The analysis of the recovery of functional and cognitive abilities as well as mood at 3 months will allow us to study the impact of BDNF on these parameters. Thus, depending on the results obtained, circulating BDNF could serve as an early marker of these.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with fibrinolysis | Experimental | Biological: Blood samples, Other: Cerebral MRI |
| Patients without fibrinolysis | Placebo comparator | Biological: Blood samples, Other: Cerebral MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients (or their person of trust in cases of inability) who have been informed about the research and given their consent to take part
- Patients aged 18 years or older
- Patients who have suffered a de novo recent ischemic stroke < 12 hours
- Patients who had cerebral imaging (CT-Scan or MRI)
- Ischemic stroke severity, measured by the National Institute of Health Stroke Score (NIHSS), between 4 and 20
Key exclusion criteria (14 listed)
- Patients without national health insurance cover
- Patients with a clinical history of stroke
- Patients with cerebral or sub-arachnoid haemorrhage
- Patients with a transient ischemic attack
- Time of symptom onset unknown
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 |
|---|---|---|
| Blood samples | Biological | Patients with fibrinolysis, Patients without fibrinolysis |
| Cerebral MRI | Other | Patients with fibrinolysis, Patients without fibrinolysis |
Primary outcome
Measurement of plasma levels of BDNF
Time frame: Change from baseline at Day1, Day 7 and Month 3
Measurement of serum levels of BDNF
Time frame: Change from baseline at Day1, Day 7 and Month 3
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 12 Mar 2026.
- Results publication: PubMed 26469350Rodier M, Quirie A, Prigent-Tessier A, Bejot Y, Jacquin A, Mossiat C, Marie C, Garnier P. Relevance of Post-Stroke Circulating BDNF Levels as a Prognostic Biomarker of Stroke Outcome. Impact of rt-PA Treatment. PLoS One. 2015 Oct 15;10(10):e0140668. doi: 10.1371/journal.pone.0140668. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples and Cerebral MRI in people with Ischemic Stroke, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 5 inclusion and 14 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 12 Mar 2026. 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 France. 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. Some participants in this study may receive a placebo. 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?
Measurement of plasma levels of BDNF (time frame: Change from baseline at Day1, Day 7 and Month 3). The study lists 2 primary outcomes in all. 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 NCT02860260, which also lists 1 linked publication.
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 12 Mar 2026.