Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00990353 |
| Other study ID # |
D-624-08 |
| Secondary ID |
1R01NS055808 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2009 |
| Est. completion date |
October 2021 |
Study information
| Verified date |
February 2021 |
| Source |
Kessler Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study examines methods to better predict improvement of a hidden disability of
functional vision, spatial neglect, following stroke. Spatial neglect is a tendency to make
visual judgment and movement errors mislocating the body and objects in space. The
investigators are using specialized statistical methods to compute the proportion of
improvement accounted for by personal characteristics of each stroke survivor, the proportion
of improvement accounted for by the unique visual-spatial errors made by each subject, and
the proportion of improvement accounted for by each treatment administered. The investigators
will also examine whether brain imaging predicts how rapidly improvement occurs. Lastly, the
study tests whether improvements that are meaningful to the survivor can be measured in a way
that still allows detection of small and scientifically eloquent performance changes.
Description:
DESCRIPTION: Spatial neglect, pathologically asymmetric spatial behavior resulting from a
brain injury (Heilman, 1979) and causing functional disability (Barrett and Burkholder, 2006)
may occur in 20-50% of strokes, up to 350,000 Americans annually (Ringman et al., 2004;
American Stroke Assoc., 2007). Difficulty eating, dressing, and navigating in complex
environments occurs acutely in this disorder, but even if symptoms improve in chronic
recovery, people with spatial neglect are more likely to lose functional independence (Katz
et al., 1999). Current standard clinical approaches are not theory driven, and
widely-employed therapies may be only marginally effective. In this proposal, we suggest two
means by which scientific acute spatial neglect treatment can be implemented. In available
studies, subject heterogeneity may have obscured treatment effects. Across methods, studies
used single subject, case series, and group analytic designs, but did not attempt to
reconcile the distinct advantages offered by individual versus group analytic approaches.
Different treatments might affect different spatial cognitive recovery functions, but simple,
global outcome measures may not reflect these changes. Modeling both subject-specific and
group effects is also an extremely useful method of examining targeted treatment effects. We
will collect spatial neglect treatment response data over four years, for two promising and
feasible spatial neglect treatments: prism adaptation training and dopaminergic medication.
With mechanism-specific outcome assessment and hierarchical linear modeling, we will examine
whether treatments result in predictable response. We will also examine whether controlling
for subject-specific predictors models group recovery trajectory. Lastly, we will examine
current standard global outcome measures instruments which have not been fully
psychometrically developed, and attempt to predict subject- and group-specific recovery
profiles for these variables. We hope this research will improve our ability to design
cognitive rehabilitation treatment studies. It may also, however, improve our ability to
translate cognitive neuroscience models of action, spatial knowledge, and attention, to
treatments to optimize adaptive movement in complex environments. PUBLIC HEALTH RELEVANCE:
This study investigates novel methods of outcome analysis for comparing two treatments for
hidden disabilities in functional vision after stroke. We hope this research will improve our
ability to design cognitive rehabilitation treatment studies. It may also, however, improve
our ability to bring basic brain science to the bedside, to optimize stroke survivors'
adaptive movement and balanced visual-spatial function in complex environments.
Although subjects are assigned to treatments in this study, we classified the study as
observational because there are no quasi-experimental options fitting its hierarchical design
under the interventional study description. At no point do we examine the independent effect
of treatments; rather, we assign subjects to treatments in order to learn if treatment exerts
an additional effect IN COMBINATION WITH 1) individual differences and 2) performance
characterization of spatial bias type immediately after stroke. We are lastly making separate
examination of the predictive effect of brain lesion location in combination with variables
1) and 2). NO traditional efficacy comparisons between the two treatments to which subjects
are assigned, are made. Neither treatment is considered "control" or "placebo," and there is
no attempt to match severity or other relevant variables between the two treatment
assignments.
