Improving care pathways for patients with rare brain tumors using AI
SIMPLIF-AI: SIMPLIFication and Standardization of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 2 sites (Milan, PA and 1 other locations) |
| Trial ID | NCT06878469 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with rare brain tumors who are native Italian speakers and candidates for craniotomy.
Not a fit: Patients undergoing stereotactic biopsies, those with psychiatric disorders, or significant cognitive decline may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, PA and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.