A Randomised Trial to Investigate the Effect of a Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Makerere University
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- Improvement in attention scores
Study Overview
Brief Summary
The purpose of this study is to determine whether computerised cognitive rehabilitation training improves cognition in children who have had cerebral malaria.
Detailed Description
Cerebral malaria affects several children in sub-Saharan Africa leaving some survivors with cognitive problems especially in attention and memory. There are currently no tested interventions for such deficits resulting from infectious diseases like malaria or other causes. Providing such interventions will go a long way in helping these children achieve their full potential.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •CM group Inclusion Criteria:
- •aged five to 15 years, presenting with asexual forms of P. falciparum malaria on a peripheral blood smear, unarousable coma (not able to localize a painful stimulus) and no other cause for coma (normal CSF).
Exclusion Criteria
- •history of or present meningitis, encephalitis, prior CM, sickle cell disease (SCD), HIV infection, epilepsy, multiple seizures, developmental delay and history of hospitalization for malnutrition.
- •Healthy control group Inclusion Criteria:
- •aged five to 15 years with no other illness at present, within two years of the CM child (for CM children aged 5 and 6 years, the HC's age wont go below 5 and for CM children aged 14 and 15, the HC's age wont go above 15 years).
- •Healthy control group Exclusion Criteria:
- •history of or present bacterial meningitis, encephalitis, CM, SCD, HIV infection, history of hospitalization for malnutrition and any chronic illness for which the patient is currently taking medication.
Arms & Interventions
Cognitive rehabilitation training
Children in this arm will the receive the intervention comprising of 16 cognitive rehabilitation training (CRT) exercises for 8 weeks. These exercises will train different cognitive skills including attention, visual spatial processing, logical skills and memory.
Intervention: Cognitive rehabilitation training (Behavioral)
Treatment as usual
Children in this group will not receive any intervention, they will undergo the usual post discharge treatment for brain injured children at Mulago Hospital (the study site). This is the treatment as usual (TAU) group.
Outcomes
Primary Outcomes
Improvement in attention scores
Time Frame: 6 months
Secondary Outcomes
- Improvement in memory, reasoning, planning, behaviour and academic achievement(6 months)
Investigators
Paul Bangirana
Dr Paul Bangirana
Makerere University