Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

Cognitive Rehabilitation in Sickle Cell Disease

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. Identifier: NCT01793740
Recruitment Status : Completed
First Posted : February 18, 2013
Last Update Posted : August 20, 2014
Information provided by (Responsible Party):
Duke University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Cognitive Impairment Behavioral: Cogmed Not Applicable

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Cogmed
These children are enrolled in the Cogmed intervention.
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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.

Layout table for eligibility information
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.

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 identifier (NCT number): NCT01793740

Layout table for location information
United States, North Carolina
Duke Child and Family Study Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Layout table for investigator information
Principal Investigator: Melanie J Bonner, PhD Duke University
Layout table for additonal information
Responsible Party: Duke University 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
Keywords provided by Duke University:
sickle cell disease
learning disability
cognitive impairment
Children with sickle cell disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn