Computerized Cognitive Rehabilitation in Children After Severe Malaria
CM_CCRT
1 other identifier
interventional
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 5, 2012
CompletedFirst Posted
Study publicly available on registry
December 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2016
CompletedMay 22, 2017
May 1, 2017
5.4 years
September 5, 2012
May 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Executive attention
Executive attention will be measured by the Test of Variables of Attention
Measured at 12 months post-intervention
Secondary Outcomes (1)
Working memory
Measured at 12 months post-intervention
Study Arms (3)
Cognitive intervention
EXPERIMENTALChildren 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.
Active control
ACTIVE COMPARATORChildren 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.
Passive control
NO INTERVENTIONNo computer training or games will be provided to this group
Interventions
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.
Eligibility Criteria
You may qualify if:
- Aged 5 to 12 years of age;
- Signed consent from the parent/guardian, assent from children aged 7 years and older;
- Completion of their 24 months testing in the parent study (MUREC no 2008-033).
You may not qualify if:
- CM: elevated cerebrospinal fluid protein, white blood cells or red blood cells
- any active illness; recent illness or recovery from illness;
- chronic illness requiring medical care; -) medical abnormalities on screening history or physical exam.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Makerere Universitylead
- Michigan State Universitycollaborator
- University of Michigancollaborator
Study Sites (1)
Makerere University
Kampala, Uganda
Related Publications (6)
Bangirana P, Allebeck P, Boivin MJ, John CC, Page C, Ehnvall A, Musisi S. Cognition, behaviour and academic skills after cognitive rehabilitation in Ugandan children surviving severe malaria: a randomised trial. BMC Neurol. 2011 Aug 4;11:96. doi: 10.1186/1471-2377-11-96.
PMID: 21816079BACKGROUNDBangirana P, Giordani B, John CC, Page C, Opoka RO, Boivin MJ. Immediate neuropsychological and behavioral benefits of computerized cognitive rehabilitation in Ugandan pediatric cerebral malaria survivors. J Dev Behav Pediatr. 2009 Aug;30(4):310-8. doi: 10.1097/DBP.0b013e3181b0f01b.
PMID: 19668094BACKGROUNDJohn CC, Bangirana P, Byarugaba J, Opoka RO, Idro R, Jurek AM, Wu B, Boivin MJ. Cerebral malaria in children is associated with long-term cognitive impairment. Pediatrics. 2008 Jul;122(1):e92-9. doi: 10.1542/peds.2007-3709. Epub 2008 Jun 9.
PMID: 18541616BACKGROUNDBoivin MJ, Nakasujja N, Sikorskii A, Opoka RO, Giordani B. A Randomized Controlled Trial to Evaluate if Computerized Cognitive Rehabilitation Improves Neurocognition in Ugandan Children with HIV. AIDS Res Hum Retroviruses. 2016 Aug;32(8):743-55. doi: 10.1089/AID.2016.0026. Epub 2016 May 2.
PMID: 27045714BACKGROUNDBoivin MJ, Kakooza AM, Warf BC, Davidson LL, Grigorenko EL. Reducing neurodevelopmental disorders and disability through research and interventions. Nature. 2015 Nov 19;527(7578):S155-60. doi: 10.1038/nature16029.
PMID: 26580321BACKGROUNDBoivin MJ, Sikorskii A, Nakasujja N, Ruisenor-Escudero H, Familiar-Lopez I, Opoka RO, Giordani B. Evaluating Immunopathogenic Biomarkers During Severe Malaria Illness as Modifiers of the Neuropsychologic Benefits of Computer Cognitive Games Rehabilitation in Ugandan Children. Pediatr Infect Dis J. 2019 Aug;38(8):840-848. doi: 10.1097/INF.0000000000002367.
PMID: 31232898DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Boivin, PhD
Michigan State University
- PRINCIPAL INVESTIGATOR
Noeline Nakasujja, PhD
Makerere University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2012
First Posted
December 6, 2012
Study Start
April 1, 2011
Primary Completion
August 23, 2016
Study Completion
August 23, 2016
Last Updated
May 22, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share