Cognitive Rehabilitation in Sickle Cell Disease

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

Tracking Information

• First Submitted Date: February 14, 2013
• First Posted Date: February 18, 2013
• Last Update Posted Date: August 20, 2014
• Study Start Date: October 2012
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 15, 2013)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 15, 2013)

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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 15, 2013)

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Cognitive Rehabilitation in Sickle Cell Disease
• Official Title: Cognitive Rehabilitation of Children With Sickle Cell Disease: A Pilot Study
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Sickle Cell Disease
• Cognitive Impairment

Intervention

Behavioral: Cogmed

Computer based program that aims to improve children's memory, attention, and processing speed.

Other Name: Cogmed computerized cognitive training

Study Arms

• Experimental: Cogmed
  These children are enrolled in the Cogmed intervention.
  Intervention: Behavioral: Cogmed
• No Intervention: Waitlist
  These children are enrolled in a waitlist condition, after which they will be offered the opportunity to complete the intervention.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 19, 2014): 18
• Original Estimated Enrollment (submitted: February 15, 2013): 30
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years to 16 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01793740
• Other Study ID Numbers: Pro00035303
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Duke University
• Original Responsible Party: Same as current
• Current Study Sponsor: Duke University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Melanie J Bonner, PhD; Duke University

• PRS Account: Duke University
• Verification Date: August 2014