NCT06951659

Brief Summary

The overall objective of this research is to investigate the clinical characteristics pre- and post-brain tumour resection with a focus on visual verticality disorder, and lateropulsion, including neuroimaging analysis, of a neurosurgical cohort of patients with brain tumours. This prospective observational cohort study will investigate clinical and neuroimaging characteristics and the relationship between lateropulsion and visual verticality disorder in patients pre- and post-brain tumour resection. Patients (aged 18-80 years, with a confirmed diagnosis of brain tumour and a neurosurgical pathway) will be enrolled from the state-wide Neurosurgery Service of Western Australia at Sir Charles Gairdner Hospital.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 12, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 19, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 13, 2025

Last Update Submit

June 17, 2025

Conditions

Keywords

Brain tumourlateropulsionvisual verticality perceptiongraviceptive neglectneurosurgeryneuroimagingstructural connectivityacute carerehabilitationneuro-oncology

Outcome Measures

Primary Outcomes (5)

  • Visual Verticality Perception (VV, visual graviceptive neglect)

    Change in VV: assessment using the bucket test method.

    Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)

  • Subjective Haptic Vertical (SHV) test

    The SHV test, the participant is blindfolded and asked to align a movable rod or bar to what they perceive as vertical using only their sense of touch (haptic input). This is to isolate somatosensory and vestibular input from visual cues. This will be performed in an upright sitting position to explore graviceptive function and verticality perception.

    Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)

  • The Four Point Pusher's Score (4PPS)

    The 4PPS is a four-item scale that measures lateropulsion or pusher syndrome. The score for each component is rated on a scale from 0 to 3 (0 to 4 for standing) and the score is based on the severity of resistance or the tilt angle when the patient begins to resist the passive movement. The score for diagnosis of Pusher behaviour is \>2 points.

    Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)

  • Scale for Contraversive Pushing

    A 3-item scale that measures lateropulsion or pusher syndrome, by rating the action / reaction of patients required to keep or change position. Scores: 0= no contraversive pushing 1. minimum score for each item 2. maximum score Score on each component \>1 indicative of lateropulsion.

    Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)

  • Resource Utilisation Group Activities of Daily Living (RUG ADL)

    The RUG-ADL score is a 4-item scale measuring motor function with activities of bed mobility, toileting, transfer and eating. The score measures the degree of assistance a patient requires for these activities. The total RUG-ADL score is calculated by summing the scores for the four ADL variables. The total RUG-ADL score ranges from a minimum score of 4 to a maximum score of 18. The higher the score the more assistance the patient requires to complete the four ADL variables.

    Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)

Other Outcomes (16)

  • Retropulsion

    Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)

  • MD Anderson Symptom Inventory - Brain Tumour (MDASI-BT)

    Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)

  • Rehabilitation Complexity Scale - extended version (RCS-E v13)

    Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)

  • +13 more other outcomes

Study Arms (1)

Patients with a brain tumour.

This study will investigate a neurosurgical cohort of patients pre and post-brain tumour resection.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the State-Wide Neurosurgical Service of Western Australia (WA) at Sir Charles Gairdner Hospital.

You may qualify if:

  • Patients of age 18 to 80 admitted to SCGH under the neurosurgery team with a confirmed diagnosis of a brain tumour.
  • Only patients who undergo partial or full brain tumour resection and are medically stable.
  • Able to provide written informed consent or consent provided by a Research Decision-Maker with the approval of an Independent Medical Practitioner (IMP) as per the Guardianship and Administration Act 1990 (GAA).
  • Patients with a support network that enables them to accommodate to travel commitments for assessments if travel to the hospital is required.

You may not qualify if:

  • Patients who undergo only biopsy will not be included.
  • Unable to follow any instructions and complete assessments due to significant medical deterioration.
  • Patients who are pregnant.
  • Current diagnosis of COVID-19 or respiratory syncytial virus (RSV), or any type of influenza.
  • Patients without a support network that enables them to accommodate to travel commitments for assessments if travel to the hospital is required.
  • An Advanced Care Health Directive prohibiting decision making by Research Decision-Maker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Charles Gairdner Osborne Park Health Care Group

Perth, Western Australia, 6009, Australia

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Taiza GS Edwards, PhD

    The University of Western Australia

    PRINCIPAL INVESTIGATOR
  • Anne-Marie Hill, PhD

    The University of Western Australia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

April 13, 2025

First Posted

April 30, 2025

Study Start

June 12, 2025

Primary Completion

December 12, 2025

Study Completion

December 30, 2025

Last Updated

June 19, 2025

Record last verified: 2025-04

Locations