Brain TumorsSIMPLIF-AINCT06878469
SIMPLIFication of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence
A study testing RehaCom in people with Brain Tumors, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumors
- What is being tested?
- RehaCom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 27 Jan 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Not yet recruiting
ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila
L’Aquila, 67100
Alessandro Ricci, MD, + 02 2394 ext. 2949, protocollogenerale@pec.asl1abruzzo.it
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, PA, 20133
GIORGIA CAMARDA, 02 2394 ext. 2949, giorgia.camarda@istituto-besta.it
About this study
Official title: SIMPLIF-AI: SIMPLIFication and Standardization of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence
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.
Read the detailed description
Participants will be adults with rare brain tumors and will be enrolled at two neurosurgery centers in Italy. The study aims to create a network of professionals specialized in predicting surgical outcomes, thereby improving the overall quality of care and the quality of life for patients.
This study aims to improve the care and outcomes for patients with rare brain tumors (rBT) by standardizing clinical pathways and utilizing advanced technologies such as Artificial Intelligence (AI) and Machine Learning (ML). Rare brain tumors, including astrocytomas, oligodendrogliomas, neuronal tumors, malignant meningiomas, and embryonal tumors, are defined as rare due to their low incidence (<6 cases per 100,000 people/year).
The study will be conducted in two phases: a retrospective phase and a prospective phase. The retrospective phase will involve the use of existing neurosurgical databases to implement ML algorithms. The prospective phase will include the collection of clinical, cognitive, and psychological data at multiple time points (pre-surgery, discharge, 3 months post-surgery, and 12 months post-surgery).
Patients will participate in an early neuro-cognitive rehabilitation program using the RehaCom software, designed to enhance cognitive functions potentially affected by surgery. The rehabilitation will be conducted at the patient's home.
The primary objective is to develop a common evaluation protocol that includes clinical, cognitive, psychological, and sociodemographic measures. Secondary objectives include identifying predictors of surgical outcomes through retrospective and prospective studies and developing predictive models for rare brain tumors.
The study will enroll approximately 200 adult patients from two neurosurgery centers in Italy. Inclusion criteria include adults (≥18 years) undergoing craniotomy for rare brain tumors, while exclusion criteria include patients undergoing stereotactic biopsy, those with psychiatric disorders, or those lacking the necessary technology for home-based rehabilitation.
The ultimate goal is to create a multidisciplinary network of professionals specialized in predicting surgical outcomes, thereby improving the overall quality of care and the quality of life for patients with rare brain tumors.
- Conditions
- Brain Tumors
- Being tested
- RehaCom
- Keywords
- Rare brain tumors, neurosurgery, outcomes predictions, Machine Learning, Artificial Intelligence, neurocognitive rehabilitation, innovative models, health care pathways, Astrocytic tumors of CNS, Oligodendroglial tumors of CNS, Ependymal tumors of CNS, Neuronal and mixed neuronal-glial tumors, Choroid plexus carcinoma of CNS, Malignant meningiomas, Embryonal tumors of CNS
- Medical subject headings
- Brain Neoplasms, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehaComDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | This group includes all adult participants with rare brain tumors who will receive early neuro-cognitive rehabilitation using the RehaCom software. Receives: Device: RehaCom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms/Signs Onset
Monitoring of headache, seizures, and neurological deficits pre- and post-operatively.
Unit of Measure: Number of patients with specific symptoms.
Measured: Pre-operative
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.
Measured: 12 months.
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.
Measured: From hospital admission until discharge
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.
Measured: 12 months
American Society of Anesthesiologists (ASA)
Assessment of the patient's physical status before surgery using the ASA classification system. This system categorizes patients based on their overall health and the presence of systemic diseases. ASA classification score from I to VI, with higher scores indicating greater severity of systemic disease and higher perioperative risk.
Measured: Pre-operative
Charlson Comorbidity Index (CCI)
The CCI evaluates comorbid conditions to predict ten-year mortality. It includes 17 categories of comorbidities, such as myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, connective tissue disease, peptic ulcer disease, liver disease, diabetes mellitus, hemiplegia, chronic kidney disease, solid tumor, leukemia, lymphoma, and AIDS. Each condition is assigned a score based on its associated risk of mortality. The total score is the sum of the individual scores for each condition, with higher scores indicating a greater number of comorbid conditions and higher predicted mortality.
Measured: Pre-operative
Magnetic Resonance Imaging (MRI)
Measurement of tumor size (in cm or mm), location (e.g., frontal lobe, temporal lobe), and side (right, left, bilateral).
Measured: 12 months.
Eloquent Area Involvement
Assessment of whether the tumor involves eloquent brain areas (motor, sensory, language, visual; dominant hemisphere). Unit of Measure: Yes/No.
Measured: Intra-operative
Cranial Nerve Manipulation
Evaluation of cranial nerve involvement during surgery. unit of Measure: Yes/No
Measured: Intra-operative
Vascular Manipulation
Assessment of vascular involvement during surgery (specify vessels: ICA, ACA, MCA, Acom, PcomA, anterior choroidal, ophthalmic, vertebral, basilar, PICA, AICA, SCA, posterior cerebral; superior sagittal sinus, transverse, sigmoid, straight, internal cerebral veins, vein of Galen, Labbe, Trolard. unit of Measure: Yes/No
Measured: Intra-operative
Extent of Resection
Measurement of the extent of tumor resection (total 100% (GTR), subtotal 90-100% (STR), partial <90% (PR), open biopsy, needle biopsy
Measured: Post-operative immediate
Edema
Evaluation of the presence and extent of edema (no, perilesional, diffuse), Unit of Measure: Yes/No, extent in cm or mm
Measured: Pre-operative
Deep Location
Assessment of whether the tumor is located in deep brain structures (basal ganglia, brainstem, pineal, thalamus, hypothalamus, unit of Measure: Yes/No
Measured: Pre-operative
Histology and Molecular Data
Histological classification according to WHO 2021, integrated with molecular data
Measured: Post-operative
Preoperative Neurological Examination (EON)
Description of deficits (none; motor; sensory; cognitive; language; cranial nerves; intracranial hypertension; epilepsy; hormonal/hypothalamic disturbances; optic pathways; cerebellar, unit of Measure: Type of deficit
Measured: Pre-operative
Tumor Side
Side of the tumor (right; left; bilateral; median).
Measured: during surgery
Tumor Location
Location of the tumor (frontal, Rolandic, Broca, insular, temporal, parietal, occipital, intraventricular (lateral only), third ventricle, sella, sella+suprasellar/parasellar, clivus, optic+optic pathways, orbit, petroclival, cavernous sinus, planum/olfactory grooves, clinoid, falx, cerebellar, cerebellopontine angle, medulla, pons, midbrain, fourth ventricle, foramen magnum, pineal).
Measured: pre-procedure
Cranial Nerve Status
Status of cranial nerves I-XII (normal; deficit), House-Brackmann scale for cranial nerve VII (1-5), hearing status for cranial nerve VIII (useful hearing; non-useful hearing), status of cranial nerves IX-X (normal; deficit; tracheostomy; PEG).
Measured: pre-procedure
Cognitive Data Collection: Phonemic Verbal Fluency
Assessment of verbal fluency by asking patients to generate as many words as possible beginning with a specific letter within a set time limit.
Unit of Measure: Number of words generated. Higher scores indicate better verbal fluency.
Measured: 12 months.
Cognitive Data Collection: Semantic Verbal Fluency
Assessment of verbal fluency by asking patients to generate as many words as possible within a specific category (e.g., animals) within a set time limit.
Unit of Measure: Number of words generated. Higher scores indicate better verbal fluency.
Measured: 12 months.
Cognitive Data Collection:Token Test
Assessment of language comprehension by asking patients to follow verbal instructions involving tokens of different shapes, sizes, and colors.
Unit of Measure: Higher scores indicate better language comprehension.
Measured: 12 months.
Cognitive Data Collection: Digit Span Forward and Backward
Assessment of working memory by asking patients to repeat a sequence of numbers in the same order (forward) and in reverse order (backward).
Unit of Measure: Number of digits correctly recalled. Higher scores indicate better working memory.
Measured: 12 months.
Cognitive Data Collection: Rey 15-Word List
Assessment of verbal memory by asking patients to recall a list of 15 words immediately after presentation and after a delay.
Unit of Measure: Number of words correctly recalled. Higher scores indicate better verbal memory.
Measured: 12 months.
Cognitive Data Collection: Rey Figure Reproduction
Assessment of visuospatial memory by asking patients to reproduce a complex figure from memory.
Unit of Measure: Score on the Rey Figure Reproduction. Higher scores indicate better visuospatial memory.
Measured: 12 months.
Cognitive Data Collection: Modified Taylor Complex Figure
Assessment of visuospatial construction and memory by asking patients to copy and then reproduce a complex figure from memory.
Unit of Measure: Score on the Modified Taylor Complex Figure. Higher scores indicate better visuospatial construction and memory.
Measured: Pre-operative, follow-up at 3 and 12 months.
Cognitive Data Collection:Trail Making Test
Assessment of attention and task-switching by asking patients to connect a sequence of numbered and lettered circles as quickly as possible.
Unit of Measure: Time taken to complete the task. Lower times indicate better performance.
Measured: Pre-operative, follow-up at 3 and 12 months.
Cognitive Data Collection: Stroop Test
Assessment of cognitive flexibility and processing speed by asking patients to name the color of the ink in which a word is printed, which may differ from the word itself (e.g., the word "red" printed in blue ink).
Unit of Measure: Time taken to complete the task. Lower times indicate better performance.
Measured: 12 months.
Cognitive Data Collection: Mini-Mental State Examination (MMSE)
Assessment of general cognitive function, including orientation, registration, attention and calculation, recall, and language.
Unit of Measure: Score on the MMSE (0-30). Higher scores indicate better cognitive function.
Measured: 12 months.
Cognitive Data Collection: Frontal Assessment Battery
Assessment of executive functions, including conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy.
Unit of Measure: Score on the FAB (0-18). Higher scores indicate better executive function.
Measured: 12 months.
Psychological and Quality of Life Data Collection: WHO Disability Assessment Schedule (WHODAS 2.0)
Assessment of disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). This tool evaluates six domains of functioning: cognition, mobility, self-care, getting along, life activities, and participation. Scores range from 0 to 100, with higher scores indicating greater disability.
Measured: 12 months.
Psychological and Quality of Life Data Collection: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Assessment of quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This 30-item questionnaire measures various aspects of quality of life in cancer patients, including physical, role, cognitive, emotional, and social functioning, as well as symptoms and global health status. Higher scores on functional scales indicate better functioning, while higher scores on symptom scales indicate worse symptoms
Measured: 12 months.
Psychological and Quality of Life Data Collection: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Brain Neoplasms 20 (EORTC QLQ-BN20)
Assessment of quality of life specific to brain tumor patients using the EORTC QLQ-BN20. This module evaluates symptoms and issues relevant to brain tumor patients, such as future uncertainty, visual disorders, motor dysfunction, and communication deficits. Higher scores indicate worse symptoms or issues.
Measured: 12 months.
Psychological and Quality of Life Data Collection: Hospital Anxiety and Depression Scale (HADS)
Assessment of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). This 14-item tool produces two subscales: HADS-A (anxiety) and HADS-D (depression). Scores range from 0 to 21 for each subscale, with higher scores indicating greater levels of anxiety or depression.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start27 Jan 2025
- Primary completion1 Jul 2025
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This group includes all adult participants with rare brain tumors who will receive early neuro-cognitive rehabilitation using the RehaCom software.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ASL 1 Avezzano Sulmona L'Aquila
- Responsible party
- Sponsor
- Investigators
- Paolo Ferroli, MD, Principal investigator, Fondazione IRCCS Istituto Neurologico Carlo BestaAlessandro Ricci, MD, Principal investigator, ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878469
- Sponsor's protocol ID
- SIMPLIF-AI
- Other IDs
- PNRR-TR1-2023-12378146
- Acronym
- SIMPLIF-AI
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fan FL, Xiong J, Li M, Wang G. On Interpretability of Artificial Neural Networks: A Survey. IEEE Trans Radiat Plasma Med Sci. 2021 Nov;5(6):741-760. doi: 10.1109/trpms.2021.3066428. Epub 2021 Mar 17.
PubMed 35573928Sagberg LM, Drewes C, Jakola AS, Solheim O. Accuracy of operating neurosurgeons' prediction of functional levels after intracranial tumor surgery. J Neurosurg. 2017 Apr;126(4):1173-1180. doi: 10.3171/2016.3.JNS152927. Epub 2016 Jun 17.
PubMed 27315026Lopez-Nunez O, Alaggio R, John I, Ciolfi A, Pedace L, Mastronuzzi A, Gianno F, Giangaspero F, Rossi S, Donofrio V, Cinalli G, Surrey LF, Tartaglia M, Locatelli F, Miele E. Melanotic Neuroectodermal Tumor of Infancy (MNTI) and Pineal Anlage Tumor (PAT) Harbor A Medulloblastoma Signature by DNA Methylation Profiling. Cancers (Basel). 2021 Feb 9;13(4):706. doi: 10.3390/cancers13040706.
PubMed 33572349Bunevicius A, Tamasauskas S, Deltuva V, Tamasauskas A, Radziunas A, Bunevicius R. Predictors of health-related quality of life in neurosurgical brain tumor patients: focus on patient-centered perspective. Acta Neurochir (Wien). 2014 Feb;156(2):367-74. doi: 10.1007/s00701-013-1930-7. Epub 2013 Nov 20.
PubMed 24254135Rolston JD, Han SJ, Lau CY, Berger MS, Parsa AT. Frequency and predictors of complications in neurological surgery: national trends from 2006 to 2011. J Neurosurg. 2014 Mar;120(3):736-45. doi: 10.3171/2013.10.JNS122419. Epub 2013 Nov 22.
PubMed 24266542Broggi M, Zattra C, Ferroli P. How to compare outcomes and complications in neurosurgery: We must make the mission possible! Surg Neurol Int. 2018 Mar 19;9:65. doi: 10.4103/sni.sni_424_17. eCollection 2018. No abstract available.
PubMed 29629232Ferroli P, Broggi M, Schiavolin S, Acerbi F, Bettamio V, Caldiroli D, Cusin A, La Corte E, Leonardi M, Raggi A, Schiariti M, Visintini S, Franzini A, Broggi G. Predicting functional impairment in brain tumor surgery: the Big Five and the Milan Complexity Scale. Neurosurg Focus. 2015 Dec;39(6):E14. doi: 10.3171/2015.9.FOCUS15339.
PubMed 26621412Senders JT, Staples PC, Karhade AV, Zaki MM, Gormley WB, Broekman MLD, Smith TR, Arnaout O. Machine Learning and Neurosurgical Outcome Prediction: A Systematic Review. World Neurosurg. 2018 Jan;109:476-486.e1. doi: 10.1016/j.wneu.2017.09.149. Epub 2017 Oct 3.
PubMed 28986230Schiavolin S, Raggi A, Scaratti C, Leonardi M, Cusin A, Visintini S, Acerbi F, Schiariti M, Zattra C, Broggi M, Ferroli P. Patients' reported outcome measures and clinical scales in brain tumor surgery: results from a prospective cohort study. Acta Neurochir (Wien). 2018 May;160(5):1053-1061. doi: 10.1007/s00701-018-3505-0. Epub 2018 Mar 3.
PubMed 29502163Reponen E, Tuominen H, Korja M. Evidence for the use of preoperative risk assessment scores in elective cranial neurosurgery: a systematic review of the literature. Anesth Analg. 2014 Aug;119(2):420-432. doi: 10.1213/ANE.0000000000000234.
PubMed 25046789
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIMPLIF-AI: SIMPLIFication and Standardization of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence
- ClinicalTrials.gov ID
- NCT06878469
- Acronym / sponsor ID
- SIMPLIF-AI / SIMPLIF-AI
- Conditions
- Brain Tumors
- Keywords
- Rare brain tumors, neurosurgery, outcomes predictions, Machine Learning, Artificial Intelligence, neurocognitive rehabilitation, innovative models, health care pathways
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Collaborators
- ASL 1 Avezzano Sulmona L'Aquila
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be adults with rare brain tumors and will be enrolled at two neurosurgery centers in Italy. The study aims to create a network of professionals specialized in predicting surgical outcomes, thereby improving the overall quality of care and the quality of life for patients.
This study aims to improve the care and outcomes for patients with rare brain tumors (rBT) by standardizing clinical pathways and utilizing advanced technologies such as Artificial Intelligence (AI) and Machine Learning (ML). Rare brain tumors, including astrocytomas, oligodendrogliomas, neuronal tumors, malignant meningiomas, and embryonal tumors, are defined as rare due to their low incidence (<6 cases per 100,000 people/year).
The study will be conducted in two phases: a retrospective phase and a prospective phase. The retrospective phase will involve the use of existing neurosurgical databases to implement ML algorithms. The prospective phase will include the collection of clinical, cognitive, and psychological data at multiple time points (pre-surgery, discharge, 3 months post-surgery, and 12 months post-surgery).
Patients will participate in an early neuro-cognitive rehabilitation program using the RehaCom software, designed to enhance cognitive functions potentially affected by surgery. The rehabilitation will be conducted at the patient's home.
The primary objective is to develop a common evaluation protocol that includes clinical, cognitive, psychological, and sociodemographic measures. Secondary objectives include identifying predictors of surgical outcomes through retrospective and prospective studies and developing predictive models for rare brain tumors.
The study will enroll approximately 200 adult patients from two neurosurgery centers in Italy. Inclusion criteria include adults (≥18 years) undergoing craniotomy for rare brain tumors, while exclusion criteria include patients undergoing stereotactic biopsy, those with psychiatric disorders, or those lacking the necessary technology for home-based rehabilitation.
The ultimate goal is to create a multidisciplinary network of professionals specialized in predicting surgical outcomes, thereby improving the overall quality of care and the quality of life for patients with rare brain tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This group includes all adult participants with rare brain tumors who will receive early neuro-cognitive rehabilitation using the RehaCom software.
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Device: RehaComThis group includes all adult participants with rare brain tumors who will receive early neuro-cognitive rehabilitation using the RehaCom software. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehaComParticipants 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. | Device | Single Group |
Primary outcome
Symptoms/Signs Onset
Time frame: Pre-operative
Monitoring of headache, seizures, and neurological deficits pre- and post-operatively. Unit of Measure: Number of patients with specific symptoms.
Karnofsky Performance Status (KPS)
Time frame: 12 months.
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)
Time frame: From hospital admission until discharge
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)
Time frame: 12 months
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.
American Society of Anesthesiologists (ASA)
Time frame: Pre-operative
Assessment of the patient's physical status before surgery using the ASA classification system. This system categorizes patients based on their overall health and the presence of systemic diseases. ASA classification score from I to VI, with higher scores indicating greater severity of systemic disease and higher perioperative risk.
Charlson Comorbidity Index (CCI)
Time frame: Pre-operative
The CCI evaluates comorbid conditions to predict ten-year mortality. It includes 17 categories of comorbidities, such as myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, connective tissue disease, peptic ulcer disease, liver disease, diabetes mellitus, hemiplegia, chronic kidney disease, solid tumor, leukemia, lymphoma, and AIDS. Each condition is assigned a score based on its associated risk of mortality. The total score is the sum of the individual scores for each condition, with higher scores indicating a greater number of comorbid conditions and higher predicted mortality.
Magnetic Resonance Imaging (MRI)
Time frame: 12 months.
Measurement of tumor size (in cm or mm), location (e.g., frontal lobe, temporal lobe), and side (right, left, bilateral).
Eloquent Area Involvement
Time frame: Intra-operative
Assessment of whether the tumor involves eloquent brain areas (motor, sensory, language, visual; dominant hemisphere). Unit of Measure: Yes/No.
Cranial Nerve Manipulation
Time frame: Intra-operative
Evaluation of cranial nerve involvement during surgery. unit of Measure: Yes/No
Vascular Manipulation
Time frame: Intra-operative
Assessment of vascular involvement during surgery (specify vessels: ICA, ACA, MCA, Acom, PcomA, anterior choroidal, ophthalmic, vertebral, basilar, PICA, AICA, SCA, posterior cerebral; superior sagittal sinus, transverse, sigmoid, straight, internal cerebral veins, vein of Galen, Labbe, Trolard. unit of Measure: Yes/No
Extent of Resection
Time frame: Post-operative immediate
Measurement of the extent of tumor resection (total 100% (GTR), subtotal 90-100% (STR), partial <90% (PR), open biopsy, needle biopsy
Edema
Time frame: Pre-operative
Evaluation of the presence and extent of edema (no, perilesional, diffuse), Unit of Measure: Yes/No, extent in cm or mm
Deep Location
Time frame: Pre-operative
Assessment of whether the tumor is located in deep brain structures (basal ganglia, brainstem, pineal, thalamus, hypothalamus, unit of Measure: Yes/No
Histology and Molecular Data
Time frame: Post-operative
Histological classification according to WHO 2021, integrated with molecular data
Preoperative Neurological Examination (EON)
Time frame: Pre-operative
Description of deficits (none; motor; sensory; cognitive; language; cranial nerves; intracranial hypertension; epilepsy; hormonal/hypothalamic disturbances; optic pathways; cerebellar, unit of Measure: Type of deficit
Tumor Side
Time frame: during surgery
Side of the tumor (right; left; bilateral; median).
Tumor Location
Time frame: pre-procedure
Location of the tumor (frontal, Rolandic, Broca, insular, temporal, parietal, occipital, intraventricular (lateral only), third ventricle, sella, sella+suprasellar/parasellar, clivus, optic+optic pathways, orbit, petroclival, cavernous sinus, planum/olfactory grooves, clinoid, falx, cerebellar, cerebellopontine angle, medulla, pons, midbrain, fourth ventricle, foramen magnum, pineal).
Cranial Nerve Status
Time frame: pre-procedure
Status of cranial nerves I-XII (normal; deficit), House-Brackmann scale for cranial nerve VII (1-5), hearing status for cranial nerve VIII (useful hearing; non-useful hearing), status of cranial nerves IX-X (normal; deficit; tracheostomy; PEG).
Cognitive Data Collection: Phonemic Verbal Fluency
Time frame: 12 months.
Assessment of verbal fluency by asking patients to generate as many words as possible beginning with a specific letter within a set time limit. Unit of Measure: Number of words generated. Higher scores indicate better verbal fluency.
Cognitive Data Collection: Semantic Verbal Fluency
Time frame: 12 months.
Assessment of verbal fluency by asking patients to generate as many words as possible within a specific category (e.g., animals) within a set time limit. Unit of Measure: Number of words generated. Higher scores indicate better verbal fluency.
Cognitive Data Collection:Token Test
Time frame: 12 months.
Assessment of language comprehension by asking patients to follow verbal instructions involving tokens of different shapes, sizes, and colors. Unit of Measure: Higher scores indicate better language comprehension.
Cognitive Data Collection: Digit Span Forward and Backward
Time frame: 12 months.
Assessment of working memory by asking patients to repeat a sequence of numbers in the same order (forward) and in reverse order (backward). Unit of Measure: Number of digits correctly recalled. Higher scores indicate better working memory.
Cognitive Data Collection: Rey 15-Word List
Time frame: 12 months.
Assessment of verbal memory by asking patients to recall a list of 15 words immediately after presentation and after a delay. Unit of Measure: Number of words correctly recalled. Higher scores indicate better verbal memory.
Cognitive Data Collection: Rey Figure Reproduction
Time frame: 12 months.
Assessment of visuospatial memory by asking patients to reproduce a complex figure from memory. Unit of Measure: Score on the Rey Figure Reproduction. Higher scores indicate better visuospatial memory.
Cognitive Data Collection: Modified Taylor Complex Figure
Time frame: Pre-operative, follow-up at 3 and 12 months.
Assessment of visuospatial construction and memory by asking patients to copy and then reproduce a complex figure from memory. Unit of Measure: Score on the Modified Taylor Complex Figure. Higher scores indicate better visuospatial construction and memory.
Cognitive Data Collection:Trail Making Test
Time frame: Pre-operative, follow-up at 3 and 12 months.
Assessment of attention and task-switching by asking patients to connect a sequence of numbered and lettered circles as quickly as possible. Unit of Measure: Time taken to complete the task. Lower times indicate better performance.
Cognitive Data Collection: Stroop Test
Time frame: 12 months.
Assessment of cognitive flexibility and processing speed by asking patients to name the color of the ink in which a word is printed, which may differ from the word itself (e.g., the word "red" printed in blue ink). Unit of Measure: Time taken to complete the task. Lower times indicate better performance.
Cognitive Data Collection: Mini-Mental State Examination (MMSE)
Time frame: 12 months.
Assessment of general cognitive function, including orientation, registration, attention and calculation, recall, and language. Unit of Measure: Score on the MMSE (0-30). Higher scores indicate better cognitive function.
Cognitive Data Collection: Frontal Assessment Battery
Time frame: 12 months.
Assessment of executive functions, including conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Unit of Measure: Score on the FAB (0-18). Higher scores indicate better executive function.
Psychological and Quality of Life Data Collection: WHO Disability Assessment Schedule (WHODAS 2.0)
Time frame: 12 months.
Assessment of disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). This tool evaluates six domains of functioning: cognition, mobility, self-care, getting along, life activities, and participation. Scores range from 0 to 100, with higher scores indicating greater disability.
Psychological and Quality of Life Data Collection: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: 12 months.
Assessment of quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This 30-item questionnaire measures various aspects of quality of life in cancer patients, including physical, role, cognitive, emotional, and social functioning, as well as symptoms and global health status. Higher scores on functional scales indicate better functioning, while higher scores on symptom scales indicate worse symptoms
Psychological and Quality of Life Data Collection: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Brain Neoplasms 20 (EORTC QLQ-BN20)
Time frame: 12 months.
Assessment of quality of life specific to brain tumor patients using the EORTC QLQ-BN20. This module evaluates symptoms and issues relevant to brain tumor patients, such as future uncertainty, visual disorders, motor dysfunction, and communication deficits. Higher scores indicate worse symptoms or issues.
Psychological and Quality of Life Data Collection: Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 months.
Assessment of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). This 14-item tool produces two subscales: HADS-A (anxiety) and HADS-D (depression). Scores range from 0 to 21 for each subscale, with higher scores indicating greater levels of anxiety or depression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Background: PubMed 35573928Fan FL, Xiong J, Li M, Wang G. On Interpretability of Artificial Neural Networks: A Survey. IEEE Trans Radiat Plasma Med Sci. 2021 Nov;5(6):741-760. doi: 10.1109/trpms.2021.3066428. Epub 2021 Mar 17.
- Background: PubMed 27315026Sagberg LM, Drewes C, Jakola AS, Solheim O. Accuracy of operating neurosurgeons' prediction of functional levels after intracranial tumor surgery. J Neurosurg. 2017 Apr;126(4):1173-1180. doi: 10.3171/2016.3.JNS152927. Epub 2016 Jun 17.
- Background: PubMed 33572349Lopez-Nunez O, Alaggio R, John I, Ciolfi A, Pedace L, Mastronuzzi A, Gianno F, Giangaspero F, Rossi S, Donofrio V, Cinalli G, Surrey LF, Tartaglia M, Locatelli F, Miele E. Melanotic Neuroectodermal Tumor of Infancy (MNTI) and Pineal Anlage Tumor (PAT) Harbor A Medulloblastoma Signature by DNA Methylation Profiling. Cancers (Basel). 2021 Feb 9;13(4):706. doi: 10.3390/cancers13040706.
- Background: PubMed 24254135Bunevicius A, Tamasauskas S, Deltuva V, Tamasauskas A, Radziunas A, Bunevicius R. Predictors of health-related quality of life in neurosurgical brain tumor patients: focus on patient-centered perspective. Acta Neurochir (Wien). 2014 Feb;156(2):367-74. doi: 10.1007/s00701-013-1930-7. Epub 2013 Nov 20.
- Background: PubMed 24266542Rolston JD, Han SJ, Lau CY, Berger MS, Parsa AT. Frequency and predictors of complications in neurological surgery: national trends from 2006 to 2011. J Neurosurg. 2014 Mar;120(3):736-45. doi: 10.3171/2013.10.JNS122419. Epub 2013 Nov 22.
- Background: PubMed 29629232Broggi M, Zattra C, Ferroli P. How to compare outcomes and complications in neurosurgery: We must make the mission possible! Surg Neurol Int. 2018 Mar 19;9:65. doi: 10.4103/sni.sni_424_17. eCollection 2018. No abstract available.
- Background: PubMed 26621412Ferroli P, Broggi M, Schiavolin S, Acerbi F, Bettamio V, Caldiroli D, Cusin A, La Corte E, Leonardi M, Raggi A, Schiariti M, Visintini S, Franzini A, Broggi G. Predicting functional impairment in brain tumor surgery: the Big Five and the Milan Complexity Scale. Neurosurg Focus. 2015 Dec;39(6):E14. doi: 10.3171/2015.9.FOCUS15339.
- Background: PubMed 28986230Senders JT, Staples PC, Karhade AV, Zaki MM, Gormley WB, Broekman MLD, Smith TR, Arnaout O. Machine Learning and Neurosurgical Outcome Prediction: A Systematic Review. World Neurosurg. 2018 Jan;109:476-486.e1. doi: 10.1016/j.wneu.2017.09.149. Epub 2017 Oct 3.
- Background: PubMed 29502163Schiavolin S, Raggi A, Scaratti C, Leonardi M, Cusin A, Visintini S, Acerbi F, Schiariti M, Zattra C, Broggi M, Ferroli P. Patients' reported outcome measures and clinical scales in brain tumor surgery: results from a prospective cohort study. Acta Neurochir (Wien). 2018 May;160(5):1053-1061. doi: 10.1007/s00701-018-3505-0. Epub 2018 Mar 3.
- Background: PubMed 25046789Reponen E, Tuominen H, Korja M. Evidence for the use of preoperative risk assessment scores in elective cranial neurosurgery: a systematic review of the literature. Anesth Analg. 2014 Aug;119(2):420-432. doi: 10.1213/ANE.0000000000000234.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paolo Ferroli, MD principal investigator
Fondazione IRCCS Istituto Neurologico Carlo Besta
Alessandro Ricci, MD principal investigator
ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RehaCom in people with Brain Tumors, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GIORGIA CAMARDA, Master's degree (+23 02 2394 ext. 2949, giorgia.camarda@istituto-besta.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms/Signs Onset (time frame: Pre-operative). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06878469, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.