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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860260
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Biological: Blood samples Other: Cerebral MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : February 2011
Actual Primary Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with fibrinolysis Biological: Blood samples
Other: Cerebral MRI
Placebo Comparator: Patients without fibrinolysis Biological: Blood samples
Other: Cerebral MRI



Primary Outcome Measures :
  1. Measurement of plasma levels of BDNF [ Time Frame: Change from baseline at Day1, Day 7 and Month 3 ]
  2. Measurement of serum levels of BDNF [ Time Frame: Change from baseline at Day1, Day 7 and Month 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860260


Locations
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France
Centre Hospitalier Universitaire
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02860260    
Other Study ID Numbers: BEJOT
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: July 2016
Keywords provided by Centre Hospitalier Universitaire Dijon:
BDNF
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia