Serotonin Selective Reuptake Inhibitor (SSRI) Effects on Cerebral Connectivity in Acute Ischemic Stroke

Study Overview
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Brief Summary
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Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients

Detailed Description
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In this placebo-controlled study, using functional resting state MRI, the investigators aim to investigate cerebral connectivity changes induced by fluoxetine given once a day for 90 days, in stroke patients with a moderate to severe motor deficit.

Official Title
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Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study

Conditions
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Stroke

Intervention / Treatment
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* Drug: Fluoxetine
* Drug: Placebo
* Radiation: fMRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First-ever ischemic stroke Cortical or subcortical stroke National Institute of Health Stroke Scale NIHSS>12 or motor NIHSS>6 at inclusion MRI-proved ischemic stroke Exclusion Criteria: pregnant or breast-feeding women alcoholism ongoing Selective Serotonin Reuptake Inhibitor treatment or interruption < 1 month allergic reaction after SSRI administration MRI contraindication NIHSS>22 Severe aphasia Coma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoxetine<br>One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI | Drug: Fluoxetine<br>* 20 mg of fluoxetine capsule per day from D0 to D90<br>Radiation: fMRI<br>* functional resting state MRI<br>|
| Placebo Comparator: Placebo<br>The other group will take a cellulose placebo per day from D0 to D90 and have fMRI | Drug: Placebo<br>* cellulose placebo per day from D0 to D90<br>Radiation: fMRI<br>* functional resting state MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracerebral connectivity in the motor network between fluoxetine and placebo group. | Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, between fluoxetine and placebo group after the treatment. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracerebral connectivity in the motor network between good responders patients | Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, in fluoxetine and placebo good responders patients, defined by : 8 points gain on the National Institute of Health Stroke Scale (NIHSS), assessed between D0 and D30 and between D0 and D90 or 2 points gain on the modified Rankin score (mRS) assessed between D0 and D30 and between D0 and D90. | 90 days | 
| Intracerebral connectivity in the motor network between non-responders patients | Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, in non-responders patients of fluoxetine and placebo group. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute ischemic stroke