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Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00658450
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : December 6, 2012
Karolinska Institutet
Information provided by (Responsible Party):
Paul Bangirana, Makerere University

Brief Summary:
The purpose of this study is to determine whether computerised cognitive rehabilitation training improves cognition in children who have had cerebral malaria.

Condition or disease Intervention/treatment Phase
Malaria, Cerebral Behavioral: Cognitive rehabilitation training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Trial to Investigate the Effect of a Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria.
Study Start Date : February 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Improvement in attention scores [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Improvement in memory, reasoning, planning, behaviour and academic achievement [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00658450

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Mulago hospital Acute Care Unit and the Cerebral Malaria Project
Kampala, Uganda, 7051
Sponsors and Collaborators
Makerere University
Karolinska Institutet
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Study Chair: Charles Ibingira, MMED Chairman, Makerere University Faculty of Medicine Research and Ethics Committee

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Responsible Party: Paul Bangirana, Dr Paul Bangirana, Makerere University Identifier: NCT00658450    
Other Study ID Numbers: 2006/HD11/4748U
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012
Keywords provided by Paul Bangirana, Makerere University:
Malaria, Cerebral
Additional relevant MeSH terms:
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Malaria, Cerebral
Cognition Disorders
Cognitive Dysfunction
Protozoan Infections
Parasitic Diseases
Neurocognitive Disorders
Mental Disorders
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases