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 HCs age won't go below 5 and for CM children aged 14 and 15, the HCs 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
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