Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke: Effect of Intravenous Fibrinolysis With Rt-PA

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Biological: Blood samples
* Other: Cerebral MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with fibrinolysis<br> | Biological: Blood samples<br> <br> Other: Cerebral MRI<br> <br> |
| Placebo Comparator: Patients without fibrinolysis<br> | Biological: Blood samples<br> <br> Other: Cerebral MRI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of plasma levels of BDNF |  | Change from baseline at Day1, Day 7 and Month 3 | 
| Measurement of serum levels of BDNF |  | Change from baseline at Day1, Day 7 and Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BDNF