Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders

Study Overview
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Brief Summary
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The Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders (MES-CoBraD) is an interdisciplinary project combining Real-World Data (RWD) from multiple clinical and consumer sources through comprehensive, cost-efficient, and fast protocols towards improving diagnostic accuracy and therapeutic outcomes in people with Complex Brain Disorders (CoBraD), as reflected in Neurocognitive (Dementia), Sleep, and Seizure (Epilepsy) disorders and their interdependence. It brings together internationally recognized experts in medicine, engineering, computer science, social health science, law, and marketing and communication from across Europe, and combines clinical information and scientific research in CoBraD with technical innovation in secure data-sharing platforms, artificial intelligence algorithms, and expert systems of precision and personalized care, with a primary focus on improving the quality of life of patients, their caregivers, and the society at large. It leverages RWD from diverse CoBraD populations across cultural, socioeconomic, educational, and health system backgrounds, with special attention on including vulnerable populations and minorities in an equitable manner and engaging key stakeholders to maximize project impact.

Official Title
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Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders

Conditions
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Dementia, Alzheimer Disease, Epilepsy, Sleep Disorder, Circadian Rhythm Disorders, Healthy

Intervention / Treatment
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* Diagnostic Test: EEG,PSG
* Diagnostic Test: biosample collection (blood and CSF)
* Diagnostic Test: neuropsychological testing
* Diagnostic Test: actigraphy
* Diagnostic Test: clinician assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants willing to undergo comprehensive assessment who visit one of three clinics (Epilepsy, Neurocognitive disorders, and Sleep Disorders), and healthy volunteers Exclusion Criteria: participant disinterest
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sleep and Circadian Disorders<br>Observational deep phenotyping of people presenting with Sleep and Circadian disorders. Participants will undergo a comprehensive multidisciplinary protocol of clinical assessment by an expert clinician, neuropsychological testing by a neuropsychologist through paper-and-pencil and tablet tests, actigraphy, polysomnography with concurrent electroencephalography, pre- and post- sleep cognitive testing and biosample acquisition, and where available provide access to wearable data, therapeutic device data (e.g., PAP/NIV), and brain imaging | Diagnostic Test: EEG,PSG<br>* concurrent overnight sleep study with full electroencephalography (in-lab or at home)<br>Diagnostic Test: biosample collection (blood and CSF)<br>* blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information<br>Diagnostic Test: neuropsychological testing<br>* paper and pencil, as well as tablet based cognitive testing<br>Diagnostic Test: actigraphy<br>* week long actigraphy assessment with concurrent sleep diary acquisition<br>Diagnostic Test: clinician assessment<br>* standard clinical assessment by an expert clinician in the respective field of brain disorders<br>|
| Neurocognitive Disorders<br>Observational deep phenotyping of people presenting with Dementia (including Alzheimer's disease, vascular disease, frontotemporal dementia). Participants will undergo a comprehensive multidisciplinary protocol of clinical assessment by an expert clinician, neuropsychological testing by a neuropsychologist through paper-and-pencil and tablet tests, actigraphy, polysomnography with concurrent electroencephalography, pre- and post- sleep cognitive testing and biosample acquisition, and where available provide access to wearable data, therapeutic device data (e.g., PAP/NIV), and brain imaging | Diagnostic Test: EEG,PSG<br>* concurrent overnight sleep study with full electroencephalography (in-lab or at home)<br>Diagnostic Test: biosample collection (blood and CSF)<br>* blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information<br>Diagnostic Test: neuropsychological testing<br>* paper and pencil, as well as tablet based cognitive testing<br>Diagnostic Test: actigraphy<br>* week long actigraphy assessment with concurrent sleep diary acquisition<br>Diagnostic Test: clinician assessment<br>* standard clinical assessment by an expert clinician in the respective field of brain disorders<br>|
| Epilepsy disorders<br>Observational deep phenotyping of people presenting with seizures and Epilepsy disorder. Participants will undergo a comprehensive multidisciplinary protocol of clinical assessment by an expert clinician, neuropsychological testing by a neuropsychologist through paper-and-pencil and tablet tests, actigraphy, polysomnography with concurrent electroencephalography, pre- and post- sleep cognitive testing and biosample acquisition, and where available provide access to wearable data, therapeutic device data (e.g., PAP/NIV), and brain imaging | Diagnostic Test: EEG,PSG<br>* concurrent overnight sleep study with full electroencephalography (in-lab or at home)<br>Diagnostic Test: biosample collection (blood and CSF)<br>* blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information<br>Diagnostic Test: neuropsychological testing<br>* paper and pencil, as well as tablet based cognitive testing<br>Diagnostic Test: actigraphy<br>* week long actigraphy assessment with concurrent sleep diary acquisition<br>Diagnostic Test: clinician assessment<br>* standard clinical assessment by an expert clinician in the respective field of brain disorders<br>|
| Healthy controls<br>Participants will undergo a comprehensive multidisciplinary protocol of clinical assessment by an expert clinician, neuropsychological testing by a neuropsychologist through paper-and-pencil and tablet tests, actigraphy, polysomnography with concurrent electroencephalography, pre- and post- sleep cognitive testing and biosample acquisition, and where available provide access to wearable data, therapeutic device data (e.g., PAP/NIV), and brain imaging | Diagnostic Test: EEG,PSG<br>* concurrent overnight sleep study with full electroencephalography (in-lab or at home)<br>Diagnostic Test: biosample collection (blood and CSF)<br>* blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information<br>Diagnostic Test: neuropsychological testing<br>* paper and pencil, as well as tablet based cognitive testing<br>Diagnostic Test: actigraphy<br>* week long actigraphy assessment with concurrent sleep diary acquisition<br>Diagnostic Test: clinician assessment<br>* standard clinical assessment by an expert clinician in the respective field of brain disorders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expert System Accuracy for the Assessment of Complex Brain Disorders | Pursuing external cross-validation using training and test sample data acquired during MES-CoBraD, examine the sensitivity, specificity, accuracy, and likelihood ratios in making an accurate diagnosis of Complex Brain Disorders (neurocognitive, epilepsy, sleep disorders), compared to gold standard diagnostic criteria. | 3 years | 
| Expert System Accuracy for the Management of Complex Brain Disorders | Pursuing external cross-validation using training and test sample data acquired during MES-CoBraD, examine the sensitivity, specificity, accuracy, and likelihood ratios in recommending standard of care treatment decisions in Complex Brain Disorders (neurocognitive, epilepsy, sleep disorders), compared to gold standard professional society recommendations. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine safety of approved therapies for Complex Brain Disorders | Test for statistically significant Side-Effect differences within 6 months of initiating approved treatments for Complex Brain Disorders between participants receiving and not receiving disease-specific therapies. Side effect reporting will be combined from patient, caregiver, and clinician input. Side effects are defined by a combination of predefined common and significant side-effect options and free text. | 3 years | 
| Prevalence co-occurrence of Complex Brain Disorders (Neurocognitive, Sleep, and Epilepsy disorders) | Within each of the three types of CoBraD, examine the frequency of comorbidity of the other two following comprehensive diagnostic protocols | 3 years | 
| Examine efficacy of approved therapies for Complex Brain Disorders | Test for statistically significant efficacy differences of using approved treatments for Complex Brain Disorders over the 3 year period of the study, between participants receiving and not receiving disease-specific therapies post sample stratification. Efficacy data will be combined from patient, caregiver, and clinician input according to the respective CoBraD efficacy outcome measures (e.g., MoCA for neurocognitive, seizure frequency and severity for epilepsy, PSQI for sleep disorders). | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial intelligence, expert systems, deep-phenotyping