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NCT Number: NCT06981156

Evaluation of the Neurologic Assessment in Pediatric Neuro-Oncology (pNANO)

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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Key information

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • greater than or equal to 1 year old
  • must be seen in the pediatric clinic
  • Radiographic or histologic confirmation of a brain or spine tumor at the time of initial diagnosis
  • Patient or parent/guardian must be able to understand the consent and be willing to sign a written informed consent document according to institutional guidelines.

Exclusion criteria

  • none specified

Treatment and study plan

pNANO Assessment

Diagnostic Test

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

Primary outcomes

  1. Inter-observer Variability in pNANO Scores: Difference in Mean Cumulative Scores

    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)

    • facial strength, cerebellar function, visual fields, extraocular movements, dysphagia, and dysarthria domains (each individually scored 0-2)
    • visual acuity domain scored from 0-1 If summed, cumulative scores range from 0 (normal) to 22 (inability to function in each relevant domain)

    Investigators will explore variability across all domains.

Secondary outcomes

  1. Feasibility: Clinical Exams that may correlate with pNANO scores

    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.

  2. Feasibility: Inter-observer variability of pNANO scores between in clinic visits and Telemedicine reported as Difference in Mean Cumulative Scores

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Connect

CONTACT

[email protected]

800-622-8922

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 20, 2025
Registry last updated
Jul 21, 2026

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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