Brain TumoursNCT06951659
Investigating Visual Verticality Disorder and Lateropulsion in a Neurosurgical Cohort of Patients With Brain Tumours
An observational study of Brain Tumours, run by The University of Western Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Tumours
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Jun 2025to 30 Dec 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the State-Wide Neurosurgical Service of Western Australia (WA) at Sir Charles Gairdner Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Sir Charles Gairdner Osborne Park Health Care Group
Perth, Western Australia, 6009
Jimena Garcia-Vega, MSc, +61 434864334, jimena.garciavega@research.uwa.edu.au
Stephen Honeybul, Neurosurgeon
About this study
Official title: Clinical, Rehabilitation and Neuroimaging Investigation of Lateropulsion, Graviceptive Neglect and Verticality Perception in Neurosurgical Patients With Brain Tumours: A Prospective Cohort Study
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.
Read the 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:
- Describe the relative frequency of lateropulsion and visual verticality disorder pre- and post-surgical resection (up to day 30 post)
- Compare the visual verticality of patients with and without lateropulsion
- Investigate the association between lateropulsion and visual verticality disorder post-surgical resection with demographic, clinical and neuroanatomical factors
- Analyse the predictive factors of functionality, lateropulsion and visual verticality disorder recovery at 30 days post-surgical resection
- Investigate the factors that influence acute care and rehabilitation LOS
- 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
- Conditions
- Brain Tumours
- Keywords
- Brain tumour, lateropulsion, visual verticality perception, graviceptive neglect, neurosurgery, neuroimaging, structural connectivity, acute care, rehabilitation, neuro-oncology
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a brain tumour. | This study will investigate a neurosurgical cohort of patients pre and post-brain tumour resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Verticality Perception (VV, visual graviceptive neglect)
Change in VV: assessment using the bucket test method.
Measured: 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.
Measured: 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.
Measured: 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
- minimum score for each item
- maximum score Score on each component >1 indicative of lateropulsion.
Measured: 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.
Measured: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start12 Jun 2025
- Primary completion12 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Charles Gairdner Hospital, University of Sao Paulo
- Responsible party
- Principal investigator, Jimena Garcia-Vega, The University of Western Australia
- Investigators
- Taiza GS Edwards, PhD, Principal investigator, The University of Western AustraliaAnne-Marie Hill, PhD, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951659
- Sponsor's protocol ID
- RGS5125
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Rehabilitation and Neuroimaging Investigation of Lateropulsion, Graviceptive Neglect and Verticality Perception in Neurosurgical Patients With Brain Tumours: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06951659
- Acronym / sponsor ID
- RGS5125
- Conditions
- Brain Tumours
- Keywords
- Brain tumour, lateropulsion, visual verticality perception, graviceptive neglect, neurosurgery, neuroimaging, structural connectivity, acute care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Collaborators
- Sir Charles Gairdner Hospital, University of Sao Paulo
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Describe the relative frequency of lateropulsion and visual verticality disorder pre- and post-surgical resection (up to day 30 post)
- Compare the visual verticality of patients with and without lateropulsion
- Investigate the association between lateropulsion and visual verticality disorder post-surgical resection with demographic, clinical and neuroanatomical factors
- Analyse the predictive factors of functionality, lateropulsion and visual verticality disorder recovery at 30 days post-surgical resection
- Investigate the factors that influence acute care and rehabilitation LOS
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a brain tumour. | – | –This study will investigate a neurosurgical cohort of patients pre and post-brain tumour resection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the State-Wide Neurosurgical Service of Western Australia (WA) at Sir Charles Gairdner Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Verticality Perception (VV, visual graviceptive neglect)
Time frame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
Change in VV: assessment using the bucket test method.
Subjective Haptic Vertical (SHV) test
Time frame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
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.
The Four Point Pusher's Score (4PPS)
Time frame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
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.
Scale for Contraversive Pushing
Time frame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
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.
Resource Utilisation Group Activities of Daily Living (RUG ADL)
Time frame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taiza GS Edwards, PhD principal investigator
The University of Western Australia
Anne-Marie Hill, PhD principal investigator
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumours, run by The University of Western Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jimena Garcia-Vega, MSc (+61 434864334, jimena.garcia-vega@research.uwa.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Verticality Perception (VV, visual graviceptive neglect) (time frame: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.