SIMPLIFication of Care Pathways for Patients with Rare Brain Tumors Through Artificial Intelligence

Study Purpose

This study focuses on rare brain tumors, which are heterogeneous entities with different morphological, biological, and clinical characteristics. Due to their rarity, many of these tumors fall under the RARECARE definition of rare tumors. The main objective of the study is to standardize care models and pathways for patients with rare brain tumors, using Artificial Intelligence (AI) and Machine Learning (ML) techniques to identify specific predictors of postoperative outcomes. The study includes both retrospective and prospective phases, with the collection of clinical, cognitive, and psychological data at various time points. Patients will undergo an early neuro-cognitive rehabilitation program using the RehaCom software, which will be conducted at home. The goal is to improve the quality of life and care for patients through a multidisciplinary and innovative approach.

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.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Adults (age ≥18 years) - Both sexes.
  • - Patients with rare brain tumors (incidence <6 cases per 100,000 people/year) - Candidates for craniotomy for rare brain tumors.
  • - Native Italian speakers for cognitive and psychological evaluation and neuro-cognitive rehabilitation.

Exclusion Criteria:

  • - Patients undergoing stereotactic/frameless biopsy.
  • - Patients with psychiatric disorders or on psychotropic medications.
  • - Patients with known cognitive decline (not due to the lesion) - Patients admitted on the same day as the surgery.
  • - Patients with severe impairments referred to rehabilitation centers.
- Patients without a Windows PC or laptop with Internet connection for neuro-cognitive rehabilitation

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.

NCT06878469
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.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Paolo Ferroli, MDAlessandro Ricci, MD
Principal Investigator Affiliation Fondazione IRCCS Istituto Neurologico Carlo BestaASL 1 Abruzzo Avezzano-Sulmona-L'Aquila
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumors
Additional Details

Participants will be adults with rare brain tumors and will be enrolled at two neurosurgery centers in Italy. The study aims to create a network of professionals specialized in predicting surgical outcomes, thereby improving the overall quality of care and the quality of life for patients. This study aims to improve the care and outcomes for patients with rare brain tumors (rBT) by standardizing clinical pathways and utilizing advanced technologies such as Artificial Intelligence (AI) and Machine Learning (ML). Rare brain tumors, including astrocytomas, oligodendrogliomas, neuronal tumors, malignant meningiomas, and embryonal tumors, are defined as rare due to their low incidence (<6 cases per 100,000 people/year). The study will be conducted in two phases: a retrospective phase and a prospective phase. The retrospective phase will involve the use of existing neurosurgical databases to implement ML algorithms. The prospective phase will include the collection of clinical, cognitive, and psychological data at multiple time points (pre-surgery, discharge, 3 months post-surgery, and 12 months post-surgery). Patients will participate in an early neuro-cognitive rehabilitation program using the RehaCom software, designed to enhance cognitive functions potentially affected by surgery. The rehabilitation will be conducted at the patient's home. The primary objective is to develop a common evaluation protocol that includes clinical, cognitive, psychological, and sociodemographic measures. Secondary objectives include identifying predictors of surgical outcomes through retrospective and prospective studies and developing predictive models for rare brain tumors. The study will enroll approximately 200 adult patients from two neurosurgery centers in Italy. Inclusion criteria include adults (≥18 years) undergoing craniotomy for rare brain tumors, while exclusion criteria include patients undergoing stereotactic biopsy, those with psychiatric disorders, or those lacking the necessary technology for home-based rehabilitation. The ultimate goal is to create a multidisciplinary network of professionals specialized in predicting surgical outcomes, thereby improving the overall quality of care and the quality of life for patients with rare brain tumors.

Arms & Interventions

Arms

Experimental: Single Group

This group includes all adult participants with rare brain tumors who will receive early neuro-cognitive rehabilitation using the RehaCom software.

Interventions

Device: - RehaCom

Participants will receive a personalized neuro-cognitive rehabilitation program using the RehaCom software. Sessions will last approximately 30/40 minutes and will be held twice a week for 8 weeks. The rehabilitation will be aimed at enhancing and/or recovering cognitive functions that may have been compromised by the neurosurgical intervention.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Milano, PA, Italy

Status

Recruiting

Address

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milano, PA, 20133

Site Contact

GIORGIA CAMARDA

[email protected]

02 2394 #2949

ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila, L'Aquila, Italy

Status

Not yet recruiting

Address

ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila

L'Aquila, , 67100

Site Contact

Alessandro Ricci, MD

[email protected]

+ 02 2394 #2949

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