About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
RehaCom
DeviceParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Symptoms/Signs Onset
Monitoring of headache, seizures, and neurological deficits pre- and post-operatively. Unit of Measure: Number of patients with specific symptoms.
Karnofsky Performance Status (KPS)
Karnofsky Performance Status (KPS) score - Assessment of functional capacity on a scale from 0 to 100, where 100 indicates no symptoms and full activity, and 0 indicates death.
Neurology Assessment in Neuro-Oncology (NANO)
NANO scale score - Evaluation of neurological function using the Neurological Assessment in Neuro-Oncology (NANO) scale, which assesses nine clinically relevant domains: gait, strength, ataxia, sensation, visual fields, facial strength, language, level of consciousness, and behavior. Each domain is scored from 0 to 4, with higher scores indicating greater impairment.
Modified Rankin Scale (mRS)
Disability score (0-6) - Measurement of disability or dependence in daily activities on a scale from 0 to 6, where 0 indicates no symptoms and 6 indicates death.
Sponsors and contacts
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead sponsor
ASL 1 Avezzano Sulmona L'Aquila
Collaborator