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

Официальное название

Clinical, Rehabilitation and Neuroimaging Investigation of Lateropulsion, Graviceptive Neglect and Verticality Perception in Neurosurgical Patients With Brain Tumours: A Prospective Cohort Study

Обзор

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.

Подробное описание

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

Первичные конечные точки

• Visual Verticality Perception (VV, visual graviceptive neglect) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Pre-brain tumour resection, acute post-brain tumour resection (day 1-5), and day 30 post-brain tumour resection (day 30)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австралия · 1 центр

• Sir Charles Gairdner Osborne Park Health Care Group — Perth

Идентификаторы

NCT: NCT06951659 · RGS5125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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