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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Biological: Blood samples; Other: Cerebral MRI

• Registration Number: NCT02860260
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2012-01
• Status Verified: 2016-07
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-08
• Last Update Submitted: 2016-08-08
• Study First Posted: 2016-08-09
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients without fibrinolysis	Cerebral MRI	-
Patients with fibrinolysis	Blood samples	-
Patients with fibrinolysis	Cerebral MRI	-
Patients without fibrinolysis	Blood samples	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire; 🇫🇷 Dijon, France