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NCT03878147

Neurodevelopmental Assessment of Children in Uganda and Malawi Using a Software Package

Completed NA Results posted Last updated 20 April 2025
What this trial tests

NA trial testing Cognitive Games Training in BPG Intervention in 599 participants. Completed in 23 December 2024.

Timeline
30 March 2020
Primary endpoint
29 February 2024
23 December 2024

Quick facts

Lead sponsorMichigan State University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment599
Start date30 March 2020
Primary completion29 February 2024
Estimated completion23 December 2024
Sites2 locations across Malawi, Uganda

Drugs / interventions tested

Conditions studied

Sponsor

Michigan State University

Who can join

Adults 5 to 12, any sex, with BPG Intervention or Control. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI) Primary · Month 2, month 6

The KABC mental processing index (MPI) is a summary score across domains. The normative mean 100 and standard deviation 15 are based on American norms. Range is 43 to 160. Higher score reflects better outcome.

Month 2
GroupValue95% CI
BPG, Uganda77.18± 0.60
Waitlist Control, Uganda74.79± 0.61
BPG, Malawi71.79± 0.71
Waitlist Control, Malawi73.72± 0.72
Month 6
GroupValue95% CI
BPG, Uganda77.27± 0.60
Waitlist Control, Uganda76.46± 0.61
BPG, Malawi73.40± 0.69
Waitlist Control, Malawi73.61± 0.70
Test of Variables of Attention (TOVA) Attention Deficit Hyperactivity Disorder (ADHD) Index Secondary · Month 2, month 6

TOVA is a computerized visual continuous performance test used in to screen, diagnose and monitor children and adults at risk for ADHD. TOVA consists of the rapid (tachistoscopic) presentation of a large geometric square on the computer screen with a smaller dark box either in the upper position (signal) or lower position (non-signal). The child is asked to press a switch in response to the signal (measuring vigilance attention), but to withhold responding to the non-signal (measuring impulsivity). The potential range of the TOVA ADHD index is from -10 to 10, higher score is better.

Month 2
GroupValue95% CI
BPG, Uganda-1.21± 0.21
Waitlist Control, Uganda-1.08± 0.21
BPG, Malawi-2.63± 0.25
Waitlist Control, Malawi-2.35± 0.25
Month 6
GroupValue95% CI
BPG, Uganda-0.81± 0.21
Waitlist Control, Uganda-0.83± 0.21
BPG, Malawi-2.23± 0.24
Waitlist Control, Malawi-2.15± 0.24
Cognitive State (CogState) Correct Moves Per Second Secondary · Month 2, month 6

CogState presents a 30-minute session that includes playing cards in a game-like manner to assess memory, attention, discrimination learning, and executive function that is non-language dependent. The number of correct moves per second during maze learning reflects executive functioning/planning. The range is from 0 to 5. Higher number reflects better outcome.

Month 2
GroupValue95% CI
BPG, Uganda0.23± 0.01
Waitlist Control, Uganda0.21± 0.01
BPG, Malawi0.20± 0.01
Waitlist Control, Malawi0.18± 0.01
Month 6
GroupValue95% CI
BPG, Uganda0.27± 0.01
Waitlist Control, Uganda0.25± 0.01
BPG, Malawi0.23± 0.01
Waitlist Control, Malawi0.22± 0.01

Sponsor's own description

The investigators will use Brain Power Games as a neurocognitive "stress test" or medical "challenge" test, in order to evaluate or improve brain/behavior functional integrity in HIV-affected children. This dual use of BPG is a key innovative feature. Each of the 5 core BPG games lasts 10 minutes and trains fine motor, monitoring/attention, visual/auditory working memory, spatial navigational learning. The investigator's central hypothesis is that the BPG performance gains will be improved compared to waitlist control for children in Uganda and Malawi.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03878147.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing