"Evaluation by Transcranial Magnetic Stimulation of the Benefit of Fluoxetine on Motor Recovery After Stroke"

• Status: Terminated
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier St Anne
• Treatments: Fluoxetine

Criteria

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