SIMPLIFication of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence

Condition(s) studied

Investigational drug(s) / intervention(s)

RehaCom: 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 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

Primary outcome measure(s)

• Symptoms/Signs Onset — 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) — 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) — 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) — 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) — 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) — 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) — 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 — 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 — Intra-operative
  Evaluation of cranial nerve involvement during surgery. unit of Measure: Yes/No
• Vascular Manipulation — 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 — 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 — 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 — 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 — Post-operative
  Histological classification according to WHO 2021, integrated with molecular data
• Preoperative Neurological Examination (EON) — 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 — during surgery
  Side of the tumor (right; left; bilateral; median).
• Tumor Location — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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) — 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 — 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) — 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) — 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) — 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) — 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.

Trial sites (2)

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