RecruitingNot ApplicableNCT06878469

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

SIMPLIF-AI: SIMPLIFication and Standardization of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence


Sponsor

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

Enrollment

200 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses artificial intelligence to help simplify the care journey for patients with rare brain tumors in Italy. AI tools will assist with planning surgery, tracking recovery, and monitoring cognitive and psychological wellbeing, with the goal of improving outcomes and reducing unnecessary steps in care. **You may be eligible if:** - You are 18 or older - You have a rare brain tumor (affecting fewer than 6 in 100,000 people per year) - You are scheduled to have brain surgery (craniotomy) for the tumor - You are a native Italian speaker **You may NOT be eligible if:** - You do not have a rare brain tumor as defined by the study - You are not a candidate for surgery - You are not a native Italian speaker (required for the cognitive and psychological assessments) - You are under 18 years of age Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERehaCom

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.


Locations(2)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, PA, Italy

ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila

L’Aquila, Italy

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NCT06878469


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