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

Ischemic Stroke Clinical Trial

— BDNF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860260
• Other study ID #: BEJOT
• Status: Completed
• Phase: N/A
• First received: August 1, 2016
• Last updated: August 8, 2016
• Start date: February 2011

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Biological:
• Blood samples

Other:
• Cerebral MRI

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of plasma levels of BDNF		Change from baseline at Day1, Day 7 and Month 3	No
Primary	Measurement of serum levels of BDNF		Change from baseline at Day1, Day 7 and Month 3	No