Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2025-12-27 @ 5:07 PM
Study NCT ID:
NCT00658450
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2008-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016779', 'term': 'Malaria, Cerebral'}], 'ancestors': [{'id': 'D020808', 'term': 'Central Nervous System Protozoal Infections'}, {'id': 'D020807', 'term': 'Central Nervous System Parasitic Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D008288', 'term': 'Malaria'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-05', 'studyFirstSubmitDate': '2008-04-10', 'studyFirstSubmitQcDate': '2008-04-14', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in attention scores', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Improvement in memory, reasoning, planning, behaviour and academic achievement', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Malaria, Cerebral'], 'conditions': ['Malaria, Cerebral']}, 'referencesModule': {'references': [{'pmid': '16930255', 'type': 'BACKGROUND', 'citation': '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': '17224457', 'type': 'BACKGROUND', '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. doi: 10.1542/peds.2006-2027. Epub 2007 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether computerised cognitive rehabilitation training improves cognition in children who have had cerebral malaria.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "CM group Inclusion Criteria:\n\n* 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).\n\nCM group Exclusion Criteria:\n\n* 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.\n\nHealthy control group Inclusion Criteria:\n\n* 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).\n\nHealthy control group Exclusion Criteria:\n\n* 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."}, 'identificationModule': {'nctId': 'NCT00658450', 'briefTitle': 'Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria', 'organization': {'class': 'OTHER', 'fullName': 'Makerere University'}, 'officialTitle': 'A Randomised Trial to Investigate the Effect of a Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria.', 'orgStudyIdInfo': {'id': '2006/HD11/4748U'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive rehabilitation training', 'description': '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.', 'interventionNames': ['Behavioral: Cognitive rehabilitation training']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': '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': [{'name': 'Cognitive rehabilitation training', 'type': 'BEHAVIORAL', 'otherNames': ['Intervention group'], 'description': '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.\n\nChildren will complete these tasks in 16 session for 8 weeks.', 'armGroupLabels': ['Cognitive rehabilitation training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7051', 'city': 'Kampala', 'state': 'Kampala', 'country': 'Uganda', 'facility': 'Mulago hospital Acute Care Unit and the Cerebral Malaria Project', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'overallOfficials': [{'name': 'Charles Ibingira, MMED', 'role': 'STUDY_CHAIR', 'affiliation': 'Chairman, Makerere University Faculty of Medicine Research and Ethics Committee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makerere University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Paul Bangirana', 'investigatorFullName': 'Paul Bangirana', 'investigatorAffiliation': 'Makerere University'}}}}