Stroke | Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke
Stroke research study
What is the primary objective of this study?
This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American sample of post-acute stroke patients. This trial will in addition examine the effect of treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial attention, as well as post-stroke fatigue and will evaluate the durability of observed effects. The results of this pilot trial will be used to develop power estimates for a larger trial and to evaluate recruitment and intervention completion rates for subjects in an American post-acute environment. There are two additional substudies: the first will use MRI to assess structural changes at the beginning and end of the intervention; the second will examine the relationship of serum biomarkers of inflammation to the intervention.
Who is eligible to participate?
Inclusion Criteria: - Ischemic infarction within 15 days - Admission NIHSS item 5 score equal to or >2 -Able to give informed consent, with surrogate consent acceptable- Exclusion Criteria: - Pre-stroke modified Rankin Scale score equal or .3 - Pregnant or lactating - Taking an SSRI on admission to SRH - Taking a medication likely to have adverse interaction with an SSRI - Unable to return for follow-up testing days 90,180 - Concurrent medial condition likely to worsen patient's functional status over next 6 months - Unable to competently participate in testing for 45min-2hrs with rest breaks - for MRI substudy: contraindication to MRI
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:fluoxetine20 mg daily for 90 days starting day 5-10 after stroke.
Drug:placebosubjects will take one pill po daily for 90 days.
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.
FluoxetineSubjects will take 20 mg fluoxetine daily for 90 days after stroke
placeboSubjects will take one pill daily for 90 days after stroke.
Start Date: April 2013
Completed Date: December 2015
Primary Outcome: Fugl-Meyer Motor Scale (FMMS)
Secondary Outcome: Western Aphasia Battery
Study sponsors, principal investigator, and references
Lead Sponsor: Spaulding Rehabilitation Hospital