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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06951659
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The University of Western Australia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Taiza GS Edwards, PhDAnne-Marie Hill, PhD
Principal Investigator Affiliation	The University of Western AustraliaThe University of Western Australia
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumours

Additional Details

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

Arms & Interventions

Arms

: Patients with a brain tumour.

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

Interventions

Contact a Trial Team

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International Sites

Perth, Western Australia, Australia

Status

Address

Sir Charles Gairdner Osborne Park Health Care Group

Perth, Western Australia, 6009

Site Contact

Jimena Garcia-Vega, MSc

[email protected]

+61 434864334

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