Investigating Visual Verticality Disorder and Lateropulsion in a Neurosurgical Cohort of Patients With Brain Tumours

NCT ID: NCT06951659

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-12

Study Completion Date

2025-12-30

Brief Summary

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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

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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

Conditions

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Brain Tumours

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with a brain tumour.

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Charles Gairdner Hospital

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role collaborator

The University of Western Australia

OTHER

Sponsor Role lead

Responsible Party

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Jimena Garcia-Vega

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Taiza GS Edwards, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Western Australia

Anne-Marie Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Western Australia

Locations

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Sir Charles Gairdner Osborne Park Health Care Group

Perth, Western Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Jimena Garcia-Vega, MSc

Role: CONTACT

+61 434864334

Anne-Marie Hill, PhD

Role: CONTACT

+61 400737570

Facility Contacts

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Jimena Garcia-Vega, MSc

Role: primary

+61 434864334

Other Identifiers

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RGS5125

Identifier Type: -

Identifier Source: org_study_id

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