Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With … (NCT02860260) | Clinical Trial Compass
CompletedNot Applicable
Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke
France50 participantsStarted 2011-02
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of plasma levels of BDNF
Timeframe: Change from baseline at Day1, Day 7 and Month 3
2
Measurement of serum levels of BDNF
Timeframe: Change from baseline at Day1, Day 7 and Month 3