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

Inclusion Criteria5

  • 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 Criteria6

  • 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

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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