Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria

Not Applicable

Completed

• Conditions: Malaria, Cerebral
• Interventions: Behavioral: Cognitive rehabilitation training

• Registration Number: NCT00658450
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-04-10
• Study First Submitted QC: 2008-04-14
• Study First Posted: 2008-04-15
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive rehabilitation training	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.

Primary Outcome Measures

Name	Time	Method
Improvement in attention scores	6 months

Secondary Outcome Measures

Name	Time	Method
Improvement in memory, reasoning, planning, behaviour and academic achievement	6 months

Trial Locations

Locations (1)

Mulago hospital Acute Care Unit and the Cerebral Malaria Project; 🇺🇬 Kampala, Uganda