Computerized Cognitive Rehabilitation in Children After Severe Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      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.
    

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).
    

Intervention name(s): Computerised cognitive rehabilitation training
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): Captain's Log
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cognitive rehabilitation; malaria; neuropsychology; attention; working memory