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Clinical Trials/NCT07286929
NCT07286929RecruitingNot Applicable

Evaluation of the Variation Over Time of Visuospatial Deficit in Patients With Parietal Lobe Glioma

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta1 site in 1 country40 target enrollmentStarted: December 3, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Change in Visuospatial Deficit Prevalence

Study Overview

Brief Summary

The goal of modern neurooncological surgery is to obtain maximum tumor resection while preserving neurological function. Parietal lobe gliomas often cause attention deficits (hemineglect) that are difficult to differentiate from other deficits. This study aims to evaluate the extent and variation over time of visuo-spatial deficits in patients undergoing surgical removal of parietal lobe gliomas. This will help characterize the cognitive profile of these patients to identify personalized treatment and rehabilitation paths.

Detailed Description

This is a single-centre, prospective, cross-sectional, observational study involving 40 patients with high- and low-grade parietal lobe glioma. The study investigates the prevalence of subjects who show a performance in cognitive visuo-spatial tests below the cut-off of the normative sample. It evaluates associations with patient-reported outcome measures (ADL, IADL), clinical-demographic aspects, radiological data (MRI), and histological/molecular data. Assessments occur at screening (pre-surgery), and at follow-up visits (3-4 months and 6 months post-surgery). Neuropsychological tests include Line Bisection, Bell and Letter Cancellation, Reading test, Apple Cancellation, and Fluff test.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients >18 years old
  • Patients must understand the Italian Language
  • Patients with suspected parietal lobe glioma

Exclusion Criteria

  • Tumor site other than parietal lobe.
  • Patients who cannot undergo surgical resection (stereotactic/open biopsy).
  • Patients who received a previous chemotherapy and/or radiotherapy treatment.
  • Patients with a history of intracranial mass lesion or traumatic brain injury.
  • Patients with a history of other CNS diseases (e.g., stroke, metastasis).
  • Patients with diagnosis of neurodegenerative disease (i.e. Alzheimer's Disease, Frontotemporal Dementia, Parkinson's Disease, Lewy Body Dementia, Amyotrophic Lateral Sclerosis).

Outcomes

Primary Outcomes

Change in Visuospatial Deficit Prevalence

Time Frame: Baseline (pre-surgery), 3-4 months post-surgery, 6 months post-surgery.

Prevalence of patients with a score below the cut-off in specific neuropsychological tests for visuo-spatial aspects (Line Bisection, Bell/Letter Cancellation, Apple Cancellation, Fluff Test) and the extent of change compared to baseline.

Secondary Outcomes

  • Association with Radiological Data(Up to 6 months post-surgery)
  • Association with Clinical-Demographic Data(Up to 6 months post-surgery.)
  • Association with Performance Status(Time Frame: Up to 6 months post-surgery.)
  • Association with Histological/Molecular Data(Up to 6 months post-surgery.)

Investigators

Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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