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Completed

NCT Number: NCT00658450

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.

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Key information

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mulago hospital Acute Care Unit and the Cerebral Malaria Project

Kampala, 7051, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive rehabilitation training

Behavioral

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: Intervention group

Primary outcomes

  1. Improvement in attention scores

    Time frame: 6 months

Secondary outcomes

  1. Improvement in memory, reasoning, planning, behaviour and academic achievement

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

A Randomised Trial to Investigate the Effect of a Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 15, 2008
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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