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A Model to Identify Specific Predictors of Spatial Neglect Recovery

This study is currently recruiting participants.
Verified March 2015 by A. M. Barrett, MD, Kessler Foundation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00990353
First Posted: October 6, 2009
Last Update Posted: April 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
A. M. Barrett, MD, Kessler Foundation
  Purpose
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.

Condition
Spatial Neglect Hemispatial Neglect Hemineglect Unilateral Neglect Visual Spatial Neglect Sensory Neglect

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparing Prism Adaptation Therapy and Bromocriptine Medication for Spatial Neglect: Theoretical and Practical Outcomes

Resource links provided by NLM:


Further study details as provided by A. M. Barrett, MD, Kessler Foundation:

Primary Outcome Measures:
  • Comparing two treatments for hidden disabilities in functional vision after stroke. [ Time Frame: 6 months ]

Estimated Enrollment: 80
Study Start Date: January 2009
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prism adaptation therapy
Bromocriptine pharmacotherapy

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stroke survivors with right brain stroke and evidence of a hidden disability of functional vision (spatial neglect)
Criteria

Inclusion Criteria:

  • Stroke survivors with right brain stroke and evidence of a hidden disability of functional vision (spatial neglect)
  • Can give consent

Exclusion Criteria:

  • Other neurological conditions
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990353


Locations
United States, New Jersey
Kessler Institute of Rehabilitation Recruiting
Chester, New Jersey, United States, 07930
Contact: Jenny Masmela, BA    973-324-3564    jmasmela@kesslerfoundation.org   
Contact: Anna M Barrett, MD    973 324-3569      
Kessler Institute of Rehabilitation Recruiting
Saddle Brook, New Jersey, United States, 07663
Contact: Jenny Masmela, BA    973-324-3564    jmasmela@kesslerfoundation.org   
Contact: Anna M Barrett, MD    973 324-3569      
Kessler Foundation Research Center Recruiting
West Orange, New Jersey, United States, 07052
Contact: Jenny Masmela, BA    973-324-3564    jmasmela@kesslerfoundation.org   
Contact: Anna Barrett, MD    973 324-3569      
Sponsors and Collaborators
Kessler Foundation
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: A M Barrett, MD Kessler Foundation
  More Information

Additional Information:
Responsible Party: A. M. Barrett, MD, Director, Stroke Research, Kessler Foundation
ClinicalTrials.gov Identifier: NCT00990353     History of Changes
Other Study ID Numbers: D-624-08
1R01NS055808-01A2 ( U.S. NIH Grant/Contract )
First Submitted: July 27, 2009
First Posted: October 6, 2009
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by A. M. Barrett, MD, Kessler Foundation:
Spatial neglect
hemineglect
stroke
cognition
prism adaptation
Hierarchical linear modeling
growth curve modeling

Additional relevant MeSH terms:
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bromocriptine
Antiparkinson Agents
Anti-Dyskinesia Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action