Cerebral Infarction | "Evaluation by Transcranial Magnetic Stimulation of the Benefit of Fluoxetine on Motor Recovery After Stroke"
Cerebral Infarction research study
What is the primary objective of this study?
The objective of this study is to better characterize the mechanisms of action of fluoxetine in motor recovery and more specifically to identify the neurophysiological substrate underlying fluoxetine-induced motor recovery in stroke. In this study, the investigators propose to use transcranial magnetic stimulation (TMS) to assess the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity.
Who is eligible to participate?
Inclusion Criteria: - Man and women, aged from 18 to 80 years. - Social security affiliation - Inclusion from day 3 to day 15 after stroke or brain haemorrhage - Hemiparesia with upper limb motor deficit (Fugl-Meyer score - hand < or = 10) - Informed consent Exclusion Criteria: - Score NIHSS > 20 - Depression (criteria DSM5-R) with MADRS score > 19 - History of recurrent bipolar or depressive disorders. - History of behavior or suicidal idea - Family history of extension of the interval QT or congenital long interval QT - History of clinical stroke - Aphasia preventing correct evaluation of motor and depression scales. - Patients treated by antidepressant drugs, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month - Benzodiazepines within 48 hours preceding inclusion. - Intolerance or allergy to fluoxetine (Sandoz® 20 mg pill) - Severe swallowing disorders preventing oral administration of the treatment - Planned carotid surgery - Pregnant or breast-feeding woman - Hepatic failure (TGO and TGP >2N); severe renal failure (creatinine >180micromol/l) - Concomitant severe disease not allowing follow-up. - Participation to another therapeutic study. - Contraindication to MRI and TMS
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Fluoxetine1 pill of 20mg / day, during 3 months
Drug:Placebo of fluoxetine1 pill of 20mg/day, during 3 months
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: February 2014
Completed Date: August 2015
Primary Outcome: Slope of the curve of recruitment of the PEMs
Secondary Outcome: Slope of recruitment of the PEMs
Study sponsors, principal investigator, and references
Principal Investigator: Jean-Claude BARON, MD
Lead Sponsor: Centre Hospitalier St Anne