Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria

NCT ID: NCT00658450

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Malaria, Cerebral

Keywords

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Malaria, Cerebral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive rehabilitation training

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Intervention group

Eligibility Criteria

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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).


* 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).

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.


* 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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role lead

Responsible Party

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Paul Bangirana

Dr Paul Bangirana

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charles Ibingira, MMED

Role: STUDY_CHAIR

Chairman, Makerere University Faculty of Medicine Research and Ethics Committee

Locations

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Mulago hospital Acute Care Unit and the Cerebral Malaria Project

Kampala, Kampala, Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type BACKGROUND
PMID: 16930255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17224457 (View on PubMed)

Other Identifiers

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2006/HD11/4748U

Identifier Type: -

Identifier Source: org_study_id