Brain Connectivity Changes in Glioma Patients During Treatment (GliRecon)

Functional Reorganization and Connectivity in Glioma Patients During the Therapeutic Trajectory

The goal of this observational study is to better understand how the brain changes during the treatment of glioma. In particular, the study looks at changes in important brain areas that are responsible for functions such as movement, language, or sensation, as well as the nerve fiber pathways that connect these areas.

The main question this study aims to answer is:

How do important brain areas and their connections adapt and reorganize over the course of glioma treatment?

Patients with glioma will undergo repeated brain imaging examinations as part of their regular medical care. These images will be analyzed over time to observe changes in brain activity and structure during different stages of therapy.

By studying these changes, researchers hope to gain new insights into the brain's ability to adapt (neuroplasticity) throughout the entire course of glioma treatment.

Study Overview

• Status: Recruiting
• Conditions: Neurocognitive Function; Gliomas, Malignant; fMRI Research; Glioma (Any Grade) in the Brain

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Raimund Kleiser, PD Dr.; Phone Number: +43 5 7680 87 - 26701; Email: raimund.kleiser@kepleruniklinikum.at
• Study Contact Backup: Name: Mario Scheweder, MSc; Phone Number: +43 50 344 27125; Email: mario.scheweder@kepleruniklinikum.at

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Recruiting
      • Kepler University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with diffuse gliomas (WHO grade 2-4) undergoing multimodal treatment and eligible for functional MRI and neurocognitive assessment.

Description

Inclusion Criteria:

• Patients with diffuse gliomas (WHO grade 2-4).
• Age >18 years and <65 years.
• Written participant information and informed consent provided and signed.
• Signed informed consent for functional magnetic resonance imaging (fMRI).

Exclusion Criteria:

• Age <18 years or >65 years.
• Pregnancy.

• Contraindications to MRI, including but not limited to:

  • Active medical implants (e.g., pain pump, defibrillator, cardiac pacemaker),
  • Orthodontic braces,
  • Metallic tattoos,
  • Non-removable piercings,
  • Known metallic foreign bodies,
  • Claustrophobia.
• Cerebral metastases from secondary (non-primary) tumors.
• Absence of baseline BOLD functional MRI and/or baseline neurocognitive assessment.
• Failure to provide written participant information and informed consent.
• Karnofsky Performance Status (KPS) <60, unless feasibility of clinical-psychological testing and BOLD fMRI is confirmed by the investigator in consultation with clinical psychology, radiology staff, and the patient.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-related changes in BOLD signal and diffusion tensor imaging (DTI) outcomes across different stages of treatment.	This outcome assesses changes from baseline in neurofunctional activation measured by blood-oxygen-level-dependent (BOLD) functional MRI and in brain microstructural properties measured by diffusion tensor imaging (DTI) parameters (e.g., fractional anisotropy and mean diffusivity) at predefined time points during treatment. Not all participants will undergo radiotherapy as part of standard clinical care; therefore, the timing of the final assessment corresponds to the respective treatment stage.	Day 0 (pre-neurosurgery baseline), Day 28 (post-surgery/pre-radiotherapy), and Day 126 to Day 140 (post-treatment)
Treatment-related changes in neurofunctional activation patterns and cerebral organizational and reorganization processes assessed by functional MRI and diffusion tensor imaging (DTI) at 1-year follow-up from treatment initiation.	This outcome assesses changes from baseline in neurofunctional activation measured by blood-oxygen-level-dependent (BOLD) functional MRI and in brain microstructural properties measured by diffusion tensor imaging (DTI) parameters (e.g., fractional anisotropy and mean diffusivity) at the one-year follow-up compared with measurements obtained at the start of treatment.	Day 0 (pre-neurosurgery baseline) and Day 365 (one-year follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOLD functional MRI signal change	Brain activation measured as blood oxygen level-dependent (BOLD) signal change using functional MRI during task-based acquisition.	Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)
Fractional anisotropy (DTI)	Fractional anisotropy values derived from diffusion tensor imaging (DTI) assessed during treatment and follow-up.	Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)
Mean diffusivity (DTI)	Mean diffusivity values derived from diffusion tensor imaging (DTI).	Day 0, Day 126-140, Day 365
Cognitive performance score	Cognitive performance assessed using standardized neuropsychological test scores.	0, Day 126-140, Day 365
Patient-reported quality of life score	Patient-reported quality of life measured using validated questionnaires.	Day 0, Day 126-140, Day 365

Collaborators and Investigators

• Sponsor: Johannes Kepler University of Linz
• Collaborators: Clinical Research Institute for Neurosciences, JKU Linz, Austria; Institute of Neuroradiology, Kepler University Hospital, Johannes Kepler University, Lin; Department of Neurosurgery, Kepler University Hospital, Johannes Kepler University Linz; Department of Radiation Oncology, Ordensklinikum Linz, Barmherzige Schwestern, Linz, Austria
• Investigators: Study Chair: Raimund Kleiser, PD Dr., Neuroimaging Sciences and Support Center ,Clinical Institute for Neurosciences, Institute of Neuroradiology, Kepler Unisversity Hospital Linz, Johannes Kepler University; Study Chair: Andreas Gruber, Full Professor, Head of Clinical Institute for Neurosciences, Head of the Departmend of Neurosurgery, Kepler Unisversity Hospital Linz, Johannes Kepler University; Study Chair: Hans Geinitz, Professor, Head of Department of Radiation Oncology, Clinical Institute for Neurosciences; Principal Investigator: Michael Sonnberger, MD, Head of Institute of Neuroradiology, Kepler University Hospital Linz, Johannes Kepler University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cognition; Brain Mapping; Neural Plasticity; Magnetic Resonance Imaging, Functional; Glioma,
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: 1419/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No