Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 7/11/2015 |
| Start Date: | April 2013 |
| End Date: | December 2015 |
Pilot RCT of Fluoxetine vs Placebo to Treat Motor, Language and Unilateral Neglect After Ischemic Stroke
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.
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.
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
We found this trial at
1
site
Spaulding Rehabilitation Hospital At Spaulding Rehabiliation Hospital Boston, our unique approach to therapy includes use...
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