"Evaluation by Transcranial Magnetic Stimulation of the Benefit of Fluoxetine on Motor Recovery After Stroke" (EFLUSTIM)
|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: NCT02063425|
Recruitment Status : Terminated (Not enough recruitment)
First Posted : February 14, 2014
Last Update Posted : October 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Infarction||Drug: Fluoxetine Drug: Placebo of fluoxetine||Not Applicable|
Recently, a phase IIb clinical trial (Chollet et al., 2011 - FLAME study) revealed that early administration of standard-dose oral fluoxetine (a selective serotonin re-uptake inhibitor widely used as antidepressant) to patients with subacute ischaemic stroke and moderate to severe motor deficit in the upper extremity enhanced motor recovery after 3 months, as assessed by the Fugl-Meyer motor scale, suggesting that fluoxetine could be a promising drug to promote recovery in stroke patients. However, the mechanisms, and their specificity, by which fluoxetine improves motor function after stroke remain poorly understood.
The overall objective of this proposal 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.
The corticospinal system plays a key role in voluntary activation of upper limb muscles. Its integrity has been related to spontaneous (but incomplete) recovery after stroke. So far, the effect of fluoxetine on corticospinal excitability and integrity has been poorly explored although this drug appears promising to promote motor recovery.
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. The investigators believe that this approach will be suitable to determine the mechanisms of action of this drug on motor recovery after stroke.
The investigators will assess in a double-blind, monocentric (Saint-Anne Hospital Stroke center), randomised, placebo-controlled study, the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity using TMS in 40 patients suffering from ischaemic stroke with hemiplegia or hemiparesis affecting motor hand functions.
By coupling TMS, visuomotor grip tracking task and several clinical scales, the investigators' results will allow a more system-specific assessment than the Fugl-Meyer motor scale of fluoxetine-induced motor hand recovery in stroke. We believe that this study will support the beneficial effect of fluoxetine to promote motor recovery in stroke and will open new vistas for treatment options using fluoxetine in patients with motor impairments. It is expected that this study will provide preliminary data that will be subsequently used to design new, more focused, clinical trials.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||"Evaluation by Transcranial Magnetic Stimulation of the Benefit of Fluoxetine on Motor Recovery After Stroke"|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
|Active Comparator: Fluoxetine||
1 pill of 20mg / day, during 3 months
Other Name: Patients receiving fluoxetine
|Placebo Comparator: Placebo||
Drug: Placebo of fluoxetine
1 pill of 20mg/day, during 3 months
Other Name: Patients receiving placebo
- Slope of the curve of recruitment of the PEMs [ Time Frame: M3 ]Significant difference, between the treated group and the group control, of the slope of the curve of recruitment of the PEMs between the beginning (D0) and the end of the treatment (processing) (M3).
- Slope of recruitment of the PEMs [ Time Frame: D0, M3, M6 ]Effect of a first dose of fluoxétine on the slope of recruitment of the PEMs.
- Slope of recruitment of the PEMs [ Time Frame: D0, M3, M6 ]Persistence of fluoxétine effect on the slope of recruitment of the PEMs to M6.
- Index finger force control in paretic hand under time-course of treatment of Fluoxetine [ Time Frame: D0, M3, M6 ]
A visuomotor tracking task is used to measure accuracy of force control (NewtonSecond, Ns) and time taken to release force (release duration, ms). Performance between time-points will be measured (Ns, before-after treatment).
Effects of fluoxetine on force control parameters (e.g., accuracy and release duration) in paretic hand.
- in index finger force control in non-paretic hand under time-course of treatment of Fluoxetine [ Time Frame: D0, M3, M6 ]Same visuomotor tracking mesures as above but acquired in non-paretic hand. Effects of fluoxetine on the non-affected hand (error, Ns; release duration, ms).
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): NCT02063425
|Centre Hospitalier Sainte-Anne|
|Paris, France, 75674|
|Study Director:||Jean-Claude BARON, MD||Centre Hospitalier Sainte-Anne|