- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01793740
Cognitive Rehabilitation in Sickle Cell Disease
August 19, 2014 updated by: Duke University
Cognitive Rehabilitation of Children With Sickle Cell Disease: A Pilot Study
The majority of school-age children with sickle cell disease (SCD) experience neurocognitive deficits, even in the absence of stroke.
In particular, deficits in attention and working memory have emerged as two of the most common neurocognitive sequelae of SCD.
Thus, the goal of the present proposal is to address feasibility and compliance of a novel computerized cognitive training program, Cogmed.
Pilot data will also be collected to establish preliminary efficacy.
Twenty-four children meeting initial age and diagnostic criteria will be identified and approached about participation by their attending physician during regularly-scheduled SCD clinic visits.
Baseline assessments will include a brief measure of intellectual functioning, a brief cognitive testing battery evaluating processing speed and working memory, in addition to questionnaires regarding behavior and quality of life.
Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist control (n=12).
Participants enrolled in the computerized CT program will be asked to complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week).
Following completion of the program, children and their parents will be asked to return to clinic for a follow-up visit.
After a five to eight-week waiting period, children in the waitlist condition will also be asked to return to clinic for a second visit.
Following this assessment, participants initially enrolled in the waitlist will be offered an opportunity to participant in the intervention.
If interested, they will follow the same intervention protocol described above.
These children will return to clinic for a third visit following completion of the intervention.
Compliance rate and its confidence interval will be calculated for the overall study population.
A t-test for binomial proportion with continuity correction will be used to examine whether the compliance rate is lower than the target.
Participants' change in criterion outcomes will be evaluated (i.e., those neurocognitive measures such as attention, executive functioning and working memory, that are most closely related to the trained tasks).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke Child and Family Study Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1) Children with a diagnosis of SCD (all genotypes)
- 2) a T-score ≥75th percentile on either the Metacognition or Executive Composite of the BRIEF; and/or
- 3) a standard score ≥1 standard deviation below the mean (<90) on the tasks of executive function or WM from the Cogstate (mean=100; SD=10)
Exclusion Criteria:
- 1) Estimated IQ ≤ 75), or motor, visual, or auditory handicap that prevents computer use;
- 2) a diagnosis of depression or a pervasive developmental disorder (by history);
- 3) clinical stroke (via record medical history); or
- 4) non-English fluency.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cogmed
These children are enrolled in the Cogmed intervention.
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Computer based program that aims to improve children's memory, attention, and processing speed.
Other Names:
|
No Intervention: Waitlist
These children are enrolled in a waitlist condition, after which they will be offered the opportunity to complete the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility
Time Frame: Post-study - Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment
|
Feasibility is defined as 75% of subjects completing 80% of the training program.
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Post-study - Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment
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Efficacy will be defined by participant performance on cognitive outcome measures including executive functioning outcomes from the Cogstate.
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Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptance
Time Frame: After the recruitment period has been completed (approximately 2-years)
|
Acceptance is defined by 50% of those approached are able to participate/consent to the study.
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After the recruitment period has been completed (approximately 2-years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Melanie J Bonner, PhD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
February 14, 2013
First Submitted That Met QC Criteria
February 15, 2013
First Posted (Estimate)
February 18, 2013
Study Record Updates
Last Update Posted (Estimate)
August 20, 2014
Last Update Submitted That Met QC Criteria
August 19, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00035303
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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