RecruitingACTRN12622001580763

Measuring recovery after scoliosis surgery

Neurocognitive trajectory in adolescents recovering from major spinal surgery for idiopathic scoliosis


Sponsor

Murdoch Children's Research Institute

Enrollment

50 participants

Start Date

Jan 15, 2024

Study Type

Observational

Conditions

Summary

This is an international study that aims to determine if there is a decline in neurocognitive function in children having scoliosis surgery. The trajectory of the child’s neurocognitive function will be assessed using well validated psychometric testing at regular intervals; baseline, 2 weeks post-operatively, 6 weeks post-operatively and 6 months post-operatively. The following aspects of neurocognition will be assessed: reaction time, attention, inhibition, and memory including working memory. The incidence and time course of post-operative delirium will be assessed in the first 48 hours or until discharge after surgery. Blood will be sampled for biomarkers during the immediate peri-operative period, for future analysis. We aim to enroll 50 children aged between 10 and 16 years. Currently we have no data on which to base recommendations for when children should return to school, what to expect in terms of functioning at school or when to sit exams after surgery. This study targets what could plausibly be a high risk group – major surgery. The findings from this study should have an immediate impact on what we tell parents as well as being an example for similar studies for other surgeries. The study will also provide data to understand aetiology, potential risk groups and possible targets for future interventions.


Eligibility

Sex: Both males and femalesMin Age: 10 YearssMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

Scoliosis — an abnormal sideways curvature of the spine — sometimes requires major corrective surgery in children and teenagers. While the surgery is generally safe, researchers and parents often wonder how it affects a child's brain function in the weeks afterward. There is currently no reliable guidance on when children should return to school or sit exams after spinal surgery, because the science simply hasn't been studied. This study will follow children aged 10 to 16 years through their scoliosis surgery, measuring cognitive function (things like attention, memory, reaction time, and impulse control) at baseline and then at 2 weeks, 6 weeks, and 6 months after the operation. It will also check for post-operative delirium in the first 48 hours, and collect blood samples for future biomarker analysis. You may be eligible if your child is aged 10 to 16, is scheduled for idiopathic scoliosis surgery, has no pre-existing neurological or developmental diagnoses, and speaks a language in which cognitive tests can be administered. The study aims to enrol 50 children and will give families practical guidance that doesn't currently exist.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The trajectory of the child’s neurocognitive function will be assessed using psychometric testing at regular intervals; baseline, 2 weeks post-operatively, 6 weeks post-operatively and 6 months post-o

The trajectory of the child’s neurocognitive function will be assessed using psychometric testing at regular intervals; baseline, 2 weeks post-operatively, 6 weeks post-operatively and 6 months post-operatively. Participants will receive the scoliosis surgery regardless of their participating in the study. The neurocognitive testing will seated computer-based tasks as well as completion of questionnaires and tests. The total testing time for the study is expected to be about 3-4 hours. Participants will be required to provide 4 blood samples for biomarker analysis. Assessments will be conducted both face-to-face at the hospital and online. Testing sessions will be supervised by the study psychologist.


Locations(3)

The Royal Childrens Hospital - Parkville

NSW,VIC, Australia

The Children's Hospital at Westmead - Westmead

NSW,VIC, Australia

Geneva, Switzerland

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ACTRN12622001580763


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