Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria
This study has been completed.
Information provided by (Responsible Party):
Paul Bangirana, Makerere University
First received: April 10, 2008
Last updated: December 5, 2012
Last verified: December 2012
The purpose of this study is to determine whether computerised cognitive rehabilitation training improves cognition in children who have had cerebral malaria.
Behavioral: Cognitive rehabilitation training
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Randomised Trial to Investigate the Effect of a Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria.
Primary Outcome Measures:
- Improvement in attention scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Improvement in memory, reasoning, planning, behaviour and academic achievement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2010 (Final data collection date for primary outcome measure)
Experimental: 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.
Behavioral: Cognitive rehabilitation training
A computerised cognitive training package where children will be required to complete several cognitive tasks. The aim is to strengthen the different cognitive processes during these tasks which in turn may lead to improve cognitive processes.
Children will complete these tasks in 16 session for 8 weeks.
Other Name: Intervention group
No Intervention: 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.
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.
|Ages Eligible for Study:
||5 Years to 15 Years (Child)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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).
CM group 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00658450
|Mulago hospital Acute Care Unit and the Cerebral Malaria Project
|Kampala, Uganda, 7051 |
||Charles Ibingira, MMED
||Chairman, Makerere University Faculty of Medicine Research and Ethics Committee
||Paul Bangirana, Dr Paul Bangirana, Makerere University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 10, 2008
||December 5, 2012
||Uganda: Research Ethics Committee
Uganda: National Council for Science and Technology
Keywords provided by Makerere University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 27, 2016
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases