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

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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected parietal lobe glioma

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (pre-surgery), 3-4 months post-surgery, 6 months post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association with Radiological Data
Time Frame: Up to 6 months post-surgery
Correlation between visuo-spatial deficit scores and MRI data (FLAIR volume, T1 contrast, necrosis, localization).
Up to 6 months post-surgery
Association with Clinical-Demographic Data
Time Frame: Up to 6 months post-surgery.
Correlation between visuo-spatial scores and hemispheric dominance, age, sex, and education.
Up to 6 months post-surgery.
Association with Performance Status
Time Frame: Time Frame: Up to 6 months post-surgery.
Correlation between visuo-spatial scores and Karnofsky Performance Status (KPS).
Time Frame: Up to 6 months post-surgery.
Association with Histological/Molecular Data
Time Frame: Up to 6 months post-surgery.
Correlation between visuo-spatial scores and tumor grade, histological and molecular features.
Up to 6 months post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Francesco Di Meco, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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