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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila
NOT_YET_RECRUITING
L’aquila
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
Contact Information
Primary
GIORGIA CAMARDA, Master's degree
giorgia.camarda@istituto-besta.it
+23 02 2394
Time Frame
Start Date: 2025-01-27
Estimated Completion Date: 2026-07
Participants
Target number of participants: 200
Treatments
Experimental: Single Group
This group includes all adult participants with rare brain tumors who will receive early neuro-cognitive rehabilitation using the RehaCom software.
Related Therapeutic Areas
Sponsors
Collaborators: ASL 1 Avezzano Sulmona L'Aquila
Leads: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

This content was sourced from clinicaltrials.gov