CompletedNot Applicable

Objective Neurocognitive Assessment of Young Children With Sickle Cell Disease by Eye-Tracking

Netherlands93 participantsStarted 2023-03-16

Plain-language summary

Evidence indicates that Sickle Cell Disease (SCD) threatens neurodevelopmental outcome. Although children with SCD may be heterogeneously affected, neurocognitive impairment may already be present in toddlers. Neurocognitive functioning is an important determinant of adaptive daily life functioning later in life and is influenced by both the course of the disease and the often suboptimal environment in which afflicted children grow up. Early identification of children at the highest risk of neurocognitive impairment would enable the deployment of early interventions to mitigate the detrimental effects of SCD on the developing brain. In order to develop such interventions, a deeper understanding of the underlying pathophysiological mechanisms is required. Therefore the main aim is to study early neurocognitive functioning and development in children with SCD between the ages of 6 and 24 months old.

Who can participate

Age range

6 Months – 24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 6 - 24 months old * Inhabitant of the Netherlands * Written informed consent from parent/caretaker. Exclusion Criteria: * Refused informed consent from parents/care-taker * Diagnosis of visual impairment (which cannot be corrected by glasses) * Diagnosis of a (co-morbid) congenital developmental condition * Any neurological condition, unrelated to SCD, that could affect the central nervous system, such as brain trauma, epilepsy and meningitis/encephalitis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial has already been completed, is there any published data or findings from it that you've seen that might tell us something about how eye-tracking results relate to neurocognitive outcomes in young children with sickle cell disease?
2This study used eye-tracking tasks to measure things like processing speed, attention, and memory recognition in young children — are these kinds of assessments something our care team already does, or could do, to monitor my child's cognitive development as part of their sickle cell care?
3Given that this trial focused on early neurocognitive signs in children with sickle cell disease, should we be proactively screening my child for attention or processing speed issues, and if so, what tools or referrals are available to us right now?
4The trial measured sustained attention and habituation, which are early markers of brain development — does my child's current sickle cell management plan address the risk of neurological or cognitive complications, and are there treatments or interventions we should be discussing?
5Since this study was observational and focused on assessment rather than treatment, are there any related clinical trials or standard-of-care programs that are actively enrolling and that might offer my child access to cognitive monitoring or support?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Processing speed in the gap condition (Gap/Overlap task)

Timeframe: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)

Processing accuracy in the gap condition (Gap/Overlap task)

Timeframe: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)

Orienting attention speed in the overlap condition (Gap/Overlap task)

Timeframe: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)

Orienting attention accuracy in the overlap condition (Gap/Overlap task)

Timeframe: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)

Alerting attention without external cues (Gap/Overlap task)

Timeframe: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)

Sustained attention across trials (Gap/Overlap task)

Timeframe: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)

Trial details

NCT IDNCT07721155

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-27

View on ClinicalTrials.gov More Sickle Cell Disease trials

Plain-language summary

Who can participate

Age range

6 Months – 24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Processing speed in the gap condition (Gap/Overlap task)

Timeframe: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)

Processing accuracy in the gap condition (Gap/Overlap task)

Timeframe: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)

Orienting attention speed in the overlap condition (Gap/Overlap task)

Timeframe: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)

Orienting attention accuracy in the overlap condition (Gap/Overlap task)

Timeframe: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)

Alerting attention without external cues (Gap/Overlap task)

Timeframe: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)

Sustained attention across trials (Gap/Overlap task)

Timeframe: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)