Status:
COMPLETED
A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
American Society of Hematology
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief Summary
The overall goal of this project is to determine the feasibility of conducting a cognitive intervention for children with sickle cell disease.
Detailed Description
The primary aims of this clinical trial are: 1. Determine the effectiveness of targeted learning and memory strategy remediation in students with sickle cell disease and cognitive deficits. 2. Determ...
Eligibility Criteria
Inclusion
- Sickle cell disease that is confirmed by hemoglobin analysis
- Has a brain magnetic resonance imaging (MRI) document reading by a neuroradiologist
- Cognitive deficits, which are defined by one standard deviation lower than the normal ranges of an age-based standard score in cognitive tests that are evaluated by a psychologist
- Must be a student who will remain in school for at least 2 years
- Must provide informed consent with assent in accordance with the institutional policies (institutional review board approval)
Exclusion
- Known developmental delays (these participants are ineligible because their learning potential may be biased from a prior insult)
- Intelligent quotient is less than 50 (may have impaired learning potential)
- Aphasic (i.e., unable to produce intelligible speech)
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00895154
Start Date
September 1 2003
End Date
December 1 2014
Last Update
May 15 2019
Active Locations (1)
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1
Washington University School of Medicine/St. Louis Children's Hospital
St Louis, Missouri, United States, 63110