Cognitive Rehabilitation in Sickle Cell Disease

NCT01793740 | Completed

• 1 other identifier: Pro00035303
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

Sickle Cell Disease; Cognitive Impairment

Keywords

sickle cell disease; pediatric; learning disability; cognitive impairment; memory; attention; Children with sickle cell disease

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Feasibility is defined as 75% of subjects completing 80% of the training program.

  Post-study - Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment

Secondary Outcomes (1)

• Efficacy

  Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment

Other Outcomes (1)

• Acceptance

  After the recruitment period has been completed (approximately 2-years)

Study Arms (2)

Cogmed

EXPERIMENTAL

These children are enrolled in the Cogmed intervention.

Behavioral: Cogmed

Waitlist

NO INTERVENTION

These children are enrolled in a waitlist condition, after which they will be offered the opportunity to complete the intervention.

Interventions

Cogmed BEHAVIORAL

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

Also known as: Cogmed computerized cognitive training

Cogmed

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \) Children with a diagnosis of SCD (all genotypes)
• \) a T-score ≥75th percentile on either the Metacognition or Executive Composite of the BRIEF; and/or
• \) 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)

You may not qualify if:

• \) Estimated IQ ≤ 75), or motor, visual, or auditory handicap that prevents computer use;
• \) a diagnosis of depression or a pervasive developmental disorder (by history);
• \) clinical stroke (via record medical history); or
• \) non-English fluency.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Cognitive Dysfunction; Learning Disabilities

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Study Officials

• Melanie J Bonner, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 18, 2013
• Study Start: October 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

US (1)