Condition category
Infections and Infestations
Date applied
10/04/2008
Date assigned
03/07/2008
Last edited
20/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Paul Bangirana

ORCID ID

Contact details

Department of Psychiatry
Makerere University Medical School
Kampala
7072
Uganda
+256 (0)772 673 831
pbangirana@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00658450

Protocol/serial number

2006/HD11/4748U

Study information

Scientific title

A randomised trial to investigate the effect of a rehabilitation program for cognitive deficits in Ugandan children after central nervous system malaria

Acronym

Study hypothesis

Please note that as of 05/02/2009 this record has been updated to include information on the revised protocol - the disease was changed from cerebral malaria to central nervous system malaria after a drop in the number of cerebral malaria cases in the study population. All updates can be found in the relevant field under the above update date. Please note that the public and scientific titles have also been updated; the initial titles were as follows:
Public title: Rehabilitation for cognitive deficits after cerebral malaria in Ugandan children
Scientific title: A randomised trial to investigate the effect of a rehabilitation program for cognitive deficits in Ugandan children after cerebral malaria
Please also note that the anticipated end date has also been extended; the initial anticipated end date was: 30/03/2009.

Current hypothesis as of 05/02/2009:
Malaria with central nervous system (CNS) involvement 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.

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

Initial hypothesis at time of registration:
Children receiving cognitive rehabilitation will have better cognitive outcomes than those not receiving cognitive rehabilitation.

Ethics approval

1. Makerere University Faculty of Medicine Research and Ethics Committee on the 31st October 2007
2. Uganda National Council of Science and Technology on the 11th December 2007

In addition to the proposal being reviewed on the above two dates, another approval for the new changes was given on the 14th Nov 2008.

Study design

Randomised controlled single centre trial (multicentre as of 05/02/2009)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malaria with CNS involvement

Intervention

A computerised cognitive training package (named Captain's Log) will be the main intervention. Children assigned to the intervention will be given cognitive training for 45 minutes, twice a week for 8 weeks (16 sessions in all). The hope is that continued use of certain cognitive functions during the training will strengthen them leading to improvement in these areas.

Duration of the treatment in the intervention arm is 16 sessions each lasting 45 minutes bi-weekly for 8 weeks (2 months). This intervention will start at 3 months post-discharge.

The control group will receive the standard post-discharge care for cerebral malaria at Mulago Hospital, the study site (treatment as usual). This includes follow up visits at the Paediatric neurology clinic if child had neurological complications at discharge. No cognitive rehabilitation takes place at this clinic.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Attention measured by the Test of Variables of Attention (TOVA).

Primary and secondary outcomes will be measured at 3 months post-discharge (just before intervention starts) and at 6 months post-discharge (a month after intervention).

Secondary outcome measures

Amended as of 20/10/2010:
1. Memory, visual spatial ability, learning and reasoning measured by the Kaufmann Assessment Battery for children second edition
2. Parental rating of behaviour measured by the child behaviour checklist
3. Academic functioning measured by the wide range achievement test, third edition

Primary and secondary outcomes will be measured at 3 months post-discharge (just before intervention starts) and at 6 months post-discharge (a month after intervention).

Initial information at time of registration:
1. Memory, planning and reasoning measured by the Kaufmann Assessment Battery for children second edition
2. Parental rating of behaviour measured by the child behaviour checklist
3. Academic functioning measured by the wide range achievement test, third edition

Primary and secondary outcomes will be measured at 3 months post-discharge (just before intervention starts) and at 6 months post-discharge (a month after intervention).

Overall trial start date

01/02/2008

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Current information as of 05/02/2009:
Study will recruit children with central nervous system malaria (CNS) and healthy controls (HC).

Inclusion criteria for CNS group:
1. Aged five to 15 years, either sex
2. Presenting with asexual forms of P. falciparum malaria on a peripheral blood smear
3. Unarousable coma (not able to localise a painful stimulus) and no other cause for coma (normal cerebrospinal fluid [CSF])
4. A history of seizures for the present illness
5. Impaired consciousness

Inclusion criteria for HC group:
1. Aged five to 15 years, either sex
2. No other illness at present
3. Within two years of the CNS child (for CNS children aged 5 and 6 years, the HC's age won't go below 5 and for CNS children aged 14 and 15, the HC's age won't go above 15 years)

Initial information at the time of registration:
Study will recruit children with cerebral malaria (CM) and healthy controls (HC).

Inclusion criteria for CM group:
1. Aged five to 15 years, either sex
2. Presenting with asexual forms of P. falciparum malaria on a peripheral blood smear
3. Unarousable coma (not able to localise a painful stimulus) and no other cause for coma (normal cerebrospinal fluid [CSF])

Inclusion criteria for HC group:
1. Aged five to 15 years, either sex
2. No other illness at present
3. Within two years of the CM child (for CM children aged 5 and 6 years, the HC’s age won't go below 5 and for CM children aged 14 and 15, the HC’s age won't go above 15 years)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

124

Participant exclusion criteria

Amended as of 20/10/2010:
Please note that the exclusion of HIV children has been removed as of 20/10/2010, meaning that children infected with HIV will now be allowed to participate in this trial.

Initial information at time of registration:
Exclusion criteria for CNS* group:
1. History of or present meningitis, encephalitis, prior CNS*, sickle cell disease (SCD), human immunodeficiency virus (HIV) infection, epilepsy, multiple seizures
2. Developmental delay
3. History of hospitalisation for malnutrition

Exclusion criteria for HC group:
1. History of or present bacterial meningitis, encephalitis, CNS, SCD, HIV infection
2. History of hospitalisation for malnutrition
3. Any chronic illness for which the patient is currently taking medication

* Please note that this changed from CM to CNS on 05/02/09 in response to updates from the Principal Investigator)

Recruitment start date

01/02/2008

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Uganda

Trial participating centre

Department of Psychiatry
Kampala
7072
Uganda

Sponsor information

Organisation

Swedish International Development Cooperation Agency (SIDA) (Sweden)

Sponsor details

Valhallavägen 199
Stockholm
105 25
Sweden
+46 (0)8 698 50 00
sida@sida.se

Sponsor type

Government

Website

http://www.sida.se

Funders

Funder type

Government

Funder name

Department for Research Cooperation (SAREC) of the Swedish International Development Cooperation Agency (SIDA) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes