American Family Children's Hospital
Madison, Wisconsin, 53792, United States
Location status: Recruiting
NCT Number: NCT06981156
This study aims to investigate a neurologic exam scale to provide an objective and more standard way to assess tumor response in pediatric patients with brain and spinal cord tumors.
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Request Info1 year–17 year
All sexes
Observational
Madison, Wisconsin, 53792, United States
Location status: Recruiting
This study is designed to evaluate inter-observer variability of the pNANO scale when implemented during routine clinic visits for pediatric brain and spine tumor patients. Typically, during a routine clinic visit for patients with pediatric brain and spine tumors, a neurological examination is completed and documented by a provider in clinic notes under the section 'Physical examination', sub-heading 'Neurologic examination.'
For this study, every participant will have neurologic examinations performed by 2 or 3 (if feasible), separate providers on the same day (patient's scheduled provider and one or two additional providers from the Study Team), during a scheduled, routine clinic visit(s). To allow for potential significant discrepancies in exams between two providers, if feasible, a third provider will complete an examination at each visit. Each provider will independently perform the neurologic examination and will document the findings on the pNANO scale scorecard.
Each provider will also record the amount of time it took to complete their neurologic examination. The providers will not communicate with each other about the findings and will be completely blinded to each other's evaluations.
The pNANO scale will be completed at a second clinic visit, between 1-6 months out from the initial assessment. Telemedicine visit evaluations will be allowed for 20% of patients enrolled on study to assess if this scale is feasible via telemedicine. For telemedicine visits, one provider will need to be in clinic to complete the first examination and the second provider will be virtual to complete the second examination on the same day. A third provider would need to be in clinic to complete an examination.
For the second evaluation 1-6 months after the first, the same will apply, one or two providers in clinic to complete the first examination while the second/third provider will be virtual. Providers can include physicians and advanced practice providers of any subspecialty: neurology, hematology-oncology, radiation oncology, neurosurgery, physical medicine and rehabilitation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
pNANO assesses patient gait, strength, cerebellar function, visual fields, visual acuity, facial strength, level of consciousness, extraocular movement, dysarthria, and dysphagia
The patient will be assessed by 2-3 different clinicians during each of 2 visits.
Other names: Pediatric Neuro-Oncology
Time frame: Visit 1 (baseline), Visit 2 (up to 6 months)
The Pediatric Neurologic Assessment in Neuro-Oncology (pNANO) is scored in multiple domains: - strength, level of consciousness, and gait domains (each individually scored 0-3)
Investigators will explore variability across all domains.
Time frame: Visit 1 (baseline), Visit 2 (up to 6 months)
Investigators will explore whether pNANO scores (individual domains or cumulative scores) correlate with clinical exams.
Time frame: Visit 1 (baseline), Visit 2 (up to 6 months)
A subset of participants (approximately 20%) will be assessed remotely to study any impact telemedicine has on pNANO scoring. If summed, cumulative scores range from 0 (normal) to 22 (inability to function in each relevant domain).
Investigators will explore variability across all domains.
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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