Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria

This study has been completed.
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Paul Bangirana, Makerere University
ClinicalTrials.gov Identifier:
NCT00658450
First received: April 10, 2008
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention
Malaria, Cerebral
Behavioral: Cognitive rehabilitation training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Makerere University:

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 ]

Enrollment: 123
Study Start Date: February 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658450

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

Publications:
Responsible Party: Paul Bangirana, Dr Paul Bangirana, Makerere University
ClinicalTrials.gov Identifier: NCT00658450     History of Changes
Other Study ID Numbers: 2006/HD11/4748U
Study First Received: April 10, 2008
Last Updated: December 5, 2012
Health Authority: Uganda: Research Ethics Committee
Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
Malaria, Cerebral

Additional relevant MeSH terms:
Malaria
Malaria, Cerebral
Protozoan Infections
Parasitic Diseases
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Malaria, Falciparum
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014