Stroke
Conditions
Keywords
stroke, recovery, fluoxetine, aphasia, neglect, motor
Brief summary
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.
Interventions
DRUGfluoxetine
20 mg daily for 90 days starting day 5-10 after stroke.
DRUGplacebo
subjects will take one pill po daily for 90 days.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Motor Scale (FMMS) | baseline to 90 days | change in FMMS score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Inattention Test (BIT) | baseline to 90 days | change in BIT |
| Functional Independence Measure | baseline to discharge | change in FIM |
| Western Aphasia Battery | baseline to 90 days | change in Western Aphasia Quotient |
| Beck Depression Inventory | baseline to 90 days | — |
| modified Rankin Scale | baseline to 90 days | — |
| Fatigue Severity Scale | baseline to 90 days | — |
Countries
United States
Outcome results
None listed