Cognitive Rehabilitation in Sickle Cell Disease
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01793740 |
Recruitment Status :
Completed
First Posted : February 18, 2013
Last Update Posted : August 20, 2014
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Condition or disease | Intervention/treatment | Phase |
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Sickle Cell Disease Cognitive Impairment | Behavioral: Cogmed | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Cognitive Rehabilitation of Children With Sickle Cell Disease: A Pilot Study |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Cogmed
These children are enrolled in the Cogmed intervention.
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Behavioral: Cogmed
Computer based program that aims to improve children's memory, attention, and processing speed.
Other Name: Cogmed computerized cognitive training |
No Intervention: Waitlist
These children are enrolled in a waitlist condition, after which they will be offered the opportunity to complete the intervention.
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- 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.
- Efficacy [ Time Frame: Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment ]Efficacy will be defined by participant performance on cognitive outcome measures including executive functioning outcomes from the Cogstate.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 8 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT01793740
United States, North Carolina | |
Duke Child and Family Study Center | |
Durham, North Carolina, United States, 27705 |
Principal Investigator: | Melanie J Bonner, PhD | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01793740 |
Other Study ID Numbers: |
Pro00035303 |
First Posted: | February 18, 2013 Key Record Dates |
Last Update Posted: | August 20, 2014 |
Last Verified: | August 2014 |
sickle cell disease pediatric learning disability cognitive impairment |
memory attention Children with sickle cell disease |
Anemia, Sickle Cell Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders Anemia, Hemolytic, Congenital |
Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |