Computerized Cognitive Rehabilitation in Children After Severe Malaria (CM_CCRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Makerere University
Sponsor:
Collaborators:
Michigan State University
University of Michigan
Information provided by (Responsible Party):
Makerere University
ClinicalTrials.gov Identifier:
NCT01743417
First received: September 5, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

Brain training exercises will be provided to children who survived an episode of severe malaria. These children will be given assessments for cognition, behaviour and executive functions before and after the brain training exercises.


Condition Intervention
Malaria
Behavioral: Computerised cognitive rehabilitation training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Computerized Cognitive Rehabilitation in Children After Severe Malaria

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Executive attention [ Time Frame: Measured at 12 months post-intervention ] [ Designated as safety issue: No ]
    Executive attention will be measured by the Test of Variables of Attention


Secondary Outcome Measures:
  • Working memory [ Time Frame: Measured at 12 months post-intervention ] [ Designated as safety issue: No ]
    Working memory will be measured by the Kaufman Assessment Battery for Children second edition


Estimated Enrollment: 300
Study Start Date: April 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cogntive intervention
Children in this arm will receive computerised cognitive rehabilitation training for 24 sessions lasting 45 minutes. The Captain's log brain training software is programmed to increase in difficulty as child progresses through the training levels.
Behavioral: Computerised cognitive rehabilitation training
24 sessions of computerised bran training will be provided for 8 weeks (+/-2) with about 3 sessions per week to the intervention arm and active control arms. The program will be programmed to increases in difficulty for the intervention arm. In the active control arms, the difficulty level will not change.
Other Name: Captain's Log
Active Comparator: Active control
Children in this arm will receive 24 sessions of computerised cognitive rehabilitation training. Captain's log, the brain training software will not be programmed to increase in difficulty with each successive level in this arm.
Behavioral: Computerised cognitive rehabilitation training
24 sessions of computerised bran training will be provided for 8 weeks (+/-2) with about 3 sessions per week to the intervention arm and active control arms. The program will be programmed to increases in difficulty for the intervention arm. In the active control arms, the difficulty level will not change.
Other Name: Captain's Log
No Intervention: Passive control
No computer training or games will be provided to this group

Detailed Description:

Background:

Our Fogarty "Brain Disorders" R21 study findings demonstrated that attention and working memory deficits persist in one out of four children with cerebral malaria (CM) (Boivin et al., 2007; John, Bangirana et al., 2008). Uganda has one of the highest incidences of malaria worldwide (~480/1000) with about 10% of these incidents becoming severe and over 90% of such cases occurring in children (Snow, Guerra, Noor, Myint, & Hay, 2005). This results in an estimated 80 thousand new cases each year of Ugandan children with mild to severe neurocognitive impairment from this disease. Such impairment will likely compromise their school performance, impede their activities of daily living, and lessen their future economic opportunities.

There is no known treatment intervention during acute illness to prevent CM brain-injury effects (Abubakar et al., 2007). Nor are neurocognitive rehabilitative treatment programs available in low-resource settings for affected children. However, we have successfully piloted a computerized cognitive rehabilitation therapy (CCRT) intervention to specifically improve attention, visual-spatial learning, and psychosocial adjustment (domains shown most affected by CM in our previous studies) with school-age Ugandan CM survivors (Bangirana, Giordani et al., 2009). This evidence justifies an R01 for further study.

The present application proposes a randomized control trial (RCT) to further establish that CCRT can improve attention, working memory, aspects of executive functioning, and psychosocial adjustment in pediatric CM survivors. Such programs are already being used extensively with children with developmental disabilities (e.g., Attention Deficit Hyperactivity Disorder, learning disorders) and brain injury in high-income countries. The evidence from RCT studies for these interventions is strong enough to warrant the evaluation of CCRT for at-risk African children (Bangirana, Idro, John, & Boivin, 2006; Boivin & Giordani, 2009). CCRT could also then be extended to a variety of other infectious diseases causing brain injury and persisting neurocognitive deficits to children in this setting (e.g., HIV, schistosomiasis, meningitis, encephalitis, and neurocysticercosis).

Objectives:

  1. To evaluate the effectiveness of CCRT in improving neuropsychological performance and psychiatric outcomes in Ugandan children who survive severe malaria.
  2. To evaluate whether severity of malaria illness (e.g., immunological brain inflammation, EEG abnormalities) is predictive of neuropsychological benefit from CCRT.
  3. METHODS

Study design:

Randomized controlled trial

Study Population:

Our proposed study groups of children aged 5 to 12 years will consist of 150 children with severe malaria (either cerebral malaria or severe malaria anemia). From the homes of these severe malaria children, we will also recruit 1 sibling (or neighbor child) 5 to 12 years of age without a history of cerebral malaria or other known infectious disease that could cause brain injury (Community Controls from Home: CC children N = 150).

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged 5 to 12 years of age;
  2. Signed consent from the parent/guardian, assent from children aged 7 years and older;
  3. Completion of their 24 months testing in the parent study (MUREC no 2008-033).

Exclusion Criteria:

  1. CM: elevated cerebrospinal fluid protein, white blood cells or red blood cells
  2. Severe malarial anemia: history of coma, impaired consciousness, repeated seizures, other brain disorder, and developmental delay. Additional exclusion criteria for CC group:

    • any active illness; recent illness or recovery from illness;
    • chronic illness requiring medical care; -) medical abnormalities on screening history or physical exam.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743417

Contacts
Contact: Paul Bangirana, PhD 256-772-673831 pbangirana@yahoo.com
Contact: Noeline Nakasujja, PhD 256-772-419700 drnoeline@yahoo.com

Locations
Uganda
Makerere University Recruiting
Kampala, Uganda
Contact: Paul Bangirana, PhD    +256772673831    pbangirana@yahoo.com   
Contact: Noeline Nakasujja, PhD    +256772419700    drnoeline@yahoo.com   
Principal Investigator: Noeline Nakasujja, PhD         
Sponsors and Collaborators
Makerere University
Michigan State University
University of Michigan
Investigators
Principal Investigator: Michael J Boivin, PhD Michigan State University
Principal Investigator: Noeline Nakasujja, PhD Makerere University
  More Information

Additional Information:
Publications:
Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT01743417     History of Changes
Other Study ID Numbers: 1R01HD064416-01A1
Study First Received: September 5, 2012
Last Updated: March 31, 2014
Health Authority: Uganda: National Council for Science and Technology
United States: Institutional Review Board

Keywords provided by Makerere University:
Cognitive rehabilitation
malaria
neuropsychology
attention
working memory

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 16, 2014