NCT00658450

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

2.7 years

First QC Date

April 10, 2008

Last Update Submit

December 5, 2012

Conditions

Malaria, Cerebral

Keywords

Malaria, Cerebral

Outcome Measures

Primary Outcomes (1)

  • Improvement in attention scores

    6 months

Secondary Outcomes (1)

  • Improvement in memory, reasoning, planning, behaviour and academic achievement

    6 months

Study Arms (2)

Cognitive rehabilitation training

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

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.

Interventions

Cognitive rehabilitation trainingBEHAVIORAL

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.

Also known as: Intervention group
Cognitive rehabilitation training

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago hospital Acute Care Unit and the Cerebral Malaria Project

Kampala, Kampala, 7051, Uganda

Location

Related Publications (2)

  • Bangirana P, Idro R, John CC, Boivin MJ. Rehabilitation for cognitive impairments after cerebral malaria in African children: strategies and limitations. Trop Med Int Health. 2006 Sep;11(9):1341-9. doi: 10.1111/j.1365-3156.2006.01685.x.

    PMID: 16930255BACKGROUND

  • Boivin MJ, Bangirana P, Byarugaba J, Opoka RO, Idro R, Jurek AM, John CC. Cognitive impairment after cerebral malaria in children: a prospective study. Pediatrics. 2007 Feb;119(2):e360-6. doi: 10.1542/peds.2006-2027. Epub 2007 Jan 15.

    PMID: 17224457BACKGROUND

MeSH Terms

Conditions

Malaria, Cerebral

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Central Nervous System Protozoal InfectionsCentral Nervous System Parasitic InfectionsCentral Nervous System InfectionsInfectionsParasitic DiseasesMalariaProtozoan InfectionsMosquito-Borne DiseasesVector Borne DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Charles Ibingira, MMED

    Chairman, Makerere University Faculty of Medicine Research and Ethics Committee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Paul Bangirana

Study Record Dates

First Submitted

April 10, 2008

First Posted

April 15, 2008

Study Start

February 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

UG(1)