Clinical trial NCT06951659: Investigating Visual Verticality Disorder and Lateropulsion in a Neurosurgical Cohort of Patients With Brain Tumours
Official title: Clinical, Rehabilitation and Neuroimaging Investigation of Lateropulsion, Graviceptive Neglect and Verticality Perception in Neurosurgical Patients With Brain Tumours: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Brain Tumours
Keywords: Brain tumour
lateropulsion
visual verticality perception
graviceptive neglect
neurosurgery
neuroimaging
structural connectivity
acute care
rehabilitation
neuro-oncology
Lead sponsor: The University of Western Australia
Sponsor class: OTHER
Collaborators: name: Sir Charles Gairdner Hospital
name: University of Sao Paulo
First posted: 2025-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the State-Wide Neurosurgical Service of Western Australia (WA) at Sir Charles Gairdner Hospital.

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.

Detailed description: Visual verticality perception disorder is the inability to judge the orientation of a vertical line or environment in relation to the Earth's vertical within normal limits, a critical symptom that affects more than half of patients after stroke and impacts global functionality i.e. difficulties maintaining upright posture and stability, poor balance, increased falls risk, and reduced ability to perform daily activities independently. Recently lateropulsion (i.e. a severe postural behavioural expression of visual verticality disorder) has been identified as the primary cause of balance and gait disorders at the subacute stage after stroke. Extending these findings, researchers have reported for the first time that visual verticality disorder and lateropulsion can also be observed in patients with brain tumours in clinical settings. However, there has been no research that has investigated the prevalence and characteristics of visual verticality disorder, and lateropulsion in neurosurgical populations of patients with brain tumours.

This prospective observational study aims to:

1. Describe the relative frequency of lateropulsion and visual verticality disorder pre- and post-surgical resection (up to day 30 post)
2. Compare the visual verticality of patients with and without lateropulsion
3. Investigate the association between lateropulsion and visual verticality disorder post-surgical resection with demographic, clinical and neuroanatomical factors
4. Analyse the predictive factors of functionality, lateropulsion and visual verticality disorder recovery at 30 days post-surgical resection
5. Investigate the factors that influence acute care and rehabilitation LOS
6. Analyse the neural network related to lateropulsion and visual verticality disorder pre- and post-surgical resection.

The preBTR assessments will be completed prior to surgery when possible. In case of an impossibility of assessing preBTR, candidates will be recruited between day 1-5 post-surgery. The postBTR assessments will commence between day 1 to 5 post-surgery (acute postBTR) and comprise of the following clinical variables listed below.

A standardised 'day-30 ± 5 days postBTR (day-30 postBTR) assessment will be performed for all patients either as an inpatient or as an outpatient. All suitable cases assessed during the six-month recruitment period will be reported.

The brain imaging analysis will comprise lesion localisation, lesion volume, indirect structural disconnection-symptom mapping measures (IDSM) and Multivariate Lesion-Symptom Mapping (MLSM).

Abbreviations: preBTR = pre-brain tumour resection, postBTR= post-brain tumour resection

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual Verticality Perception (VV, visual graviceptive neglect)
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: Subjective Haptic Vertical (SHV) test
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: The Four Point Pusher's Score (4PPS)
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: Scale for Contraversive Pushing
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: Resource Utilisation Group Activities of Daily Living (RUG ADL)
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
Secondary outcomes:
Other outcomes:
measure: Retropulsion
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: MD Anderson Symptom Inventory - Brain Tumour (MDASI-BT)
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: Rehabilitation Complexity Scale - extended version (RCS-E v13)
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: Postural Assessment Scale for Stroke (PASS)
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: Australian Modified Karnofsky Performance Scale (AKPS)
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: NIH Stroke Scale (NIHSS)
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Pre-brain tumour resection and post-brain tumour resection acute (1-5 days)
measure: Edinburgh Inventory Handedness Assessment
timeFrame: Pre-brain tumour resection
measure: Visual field testing
timeFrame: Pre-brain tumour resection
measure: Nystagmus
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: Ocular torsion
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: Vestibular screening - Benign Paroxysmal Positional Vertigo (BPPV)
timeFrame: Pre-brain tumour resection
measure: Spatial neglect
timeFrame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
measure: Vestibular screening - Head Impulse Test (HIT)
timeFrame: Pre-brain tumour resection
measure: Brain magnetic resonance imaging (MRI)
timeFrame: Pre-brain tumour resection, and day 30 post-brain tumour resection (day 30)
measure: Vestibular screening - Head Shake test
timeFrame: Pre-brain tumour resection
Locations:
city: Perth
country: Australia
facility: Sir Charles Gairdner Osborne Park Health Care Group
state: Western Australia
Study officials:
affiliation: The University of Western Australia
name: Taiza GS Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Western Australia
name: Anne-Marie Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References: