We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00658450
First Posted: April 15, 2008
Last Update Posted: December 6, 2012
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.
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Paul Bangirana, Makerere University
April 10, 2008
April 15, 2008
December 6, 2012
February 2008
October 2010   (Final data collection date for primary outcome measure)
Improvement in attention scores [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00658450 on ClinicalTrials.gov Archive Site
Improvement in memory, reasoning, planning, behaviour and academic achievement [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
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.
The purpose of this study is to determine whether computerised cognitive rehabilitation training improves cognition in children who have had cerebral malaria.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malaria, Cerebral
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
  • 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.
    Intervention: Behavioral: Cognitive rehabilitation training
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
October 2010
October 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
5 Years to 15 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Uganda
 
 
NCT00658450
2006/HD11/4748U
Yes
Not Provided
Not Provided
Paul Bangirana, Makerere University
Makerere University
Karolinska Institutet
Study Chair: Charles Ibingira, MMED Chairman, Makerere University Faculty of Medicine Research and Ethics Committee
Makerere University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP