Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria

Malaria, Cerebral Clinical Trial

Official title:

A Randomised Trial to Investigate the Effect of a Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658450
• Other study ID #: 2006/HD11/4748U
• Status: Completed
• Phase: N/A
• First received: April 10, 2008
• Last updated: December 5, 2012
• Start date: February 2008
• Est. completion date: October 2010

Study information

• Verified date: December 2012
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Research Ethics CommitteeUganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

CM group 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Malaria
• Malaria, Cerebral

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Uganda	Mulago hospital Acute Care Unit and the Cerebral Malaria Project	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
Makerere University	Karolinska Institutet

Country where clinical trial is conducted

Uganda, 

References & 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. Review. — View Citation

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. Epub 2007 Jan 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in attention scores		6 months	No
Secondary	Improvement in memory, reasoning, planning, behaviour and academic achievement		6 months	No