Improving care pathways for patients with rare brain tumors using AI
Official title: SIMPLIF-AI: SIMPLIFication and Standardization of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence
Run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · NCT06878469 · Data updated 2026-11-12
This study is testing whether using AI to improve treatment plans can help people with rare brain tumors have better care and quality of life through a home rehabilitation program.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 2 sites (Milan, PA and 1 other locations) |
| Status | Recruiting |
| Started | January 27, 2025 |
| Main results expected | July 1, 2025 |
| Study ends | February 2027 |
| Registry record updated | February 19, 2026 |
| Trial ID | NCT06878469 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with rare brain tumors who are native Italian speakers and candidates for craniotomy.
✕Probably not a fit
Patients undergoing stereotactic biopsies, those with psychiatric disorders, or significant cognitive decline may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on enhancing the care and outcomes for patients with rare brain tumors by standardizing clinical pathways through the use of Artificial Intelligence (AI) and Machine Learning (ML). It involves both retrospective and prospective phases, where clinical, cognitive, and psychological data will be collected at various time points. Participants will undergo an early neuro-cognitive rehabilitation program using RehaCom software at home, aiming to improve their quality of life. The study will be conducted at two neurosurgery centers in Italy, creating a network of professionals to predict surgical outcomes.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of care and postoperative outcomes for patients with rare brain tumors.
How similar studies have gone: While the use of AI in healthcare is gaining traction, this specific approach to standardizing care for rare brain tumors is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full 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
Where it's running
-
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, PA, Italy Recruiting -
ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila
L’Aquila, Italy Not yet recruiting
Study contacts
- Principal investigator: Paolo Ferroli, MD — Fondazione IRCCS Istituto Neurologico Carlo Besta
- Study coordinator: GIORGIA CAMARDA, Master's degree
- Email: giorgia.camarda@istituto-besta.it
- Phone: +23 02 2394
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.