- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00658450
Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria
A Randomised Trial to Investigate the Effect of a Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kampala, Uganda, 7051
- Mulago hospital Acute Care Unit and the Cerebral Malaria Project
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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 Names:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Improvement in attention scores
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Improvement in memory, reasoning, planning, behaviour and academic achievement
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Charles Ibingira, MMED, Chairman, Makerere University Faculty of Medicine Research and Ethics Committee
Publications and helpful links
General Publications
- Bangirana P, Idro R, John CC, Boivin MJ. Rehabilitation for cognitive impairments after cerebral malaria in African children: strategies and limitations. Trop Med Int Health. 2006 Sep;11(9):1341-9. doi: 10.1111/j.1365-3156.2006.01685.x.
- Boivin MJ, Bangirana P, Byarugaba J, Opoka RO, Idro R, Jurek AM, John CC. Cognitive impairment after cerebral malaria in children: a prospective study. Pediatrics. 2007 Feb;119(2):e360-6. doi: 10.1542/peds.2006-2027. Epub 2007 Jan 15.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Neurocognitive Disorders
- Central Nervous System Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Central Nervous System Parasitic Infections
- Central Nervous System Protozoal Infections
- Cognitive Dysfunction
- Malaria
- Cognition Disorders
- Malaria, Cerebral
Other Study ID Numbers
- 2006/HD11/4748U
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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