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

NCT ID: NCT02860260

Last Updated: 2016-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Patients with fibrinolysis

Group Type: EXPERIMENTAL

Blood samples

Intervention Type: BIOLOGICAL

Cerebral MRI

Intervention Type: OTHER

Patients without fibrinolysis

Group Type: PLACEBO_COMPARATOR

Blood samples

Intervention Type: BIOLOGICAL

Cerebral MRI

Intervention Type: OTHER

Interventions

Blood samples

Intervention Type: BIOLOGICAL

Cerebral MRI

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire

Dijon, , France

Countries

France

Other Identifiers

BEJOT

Identifier Type: -

Identifier Source: org_study_id