Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders
Recruiting
- Conditions
- EpilepsyHealthyDementiaCircadian Rhythm DisordersAlzheimer DiseaseSleep Disorder
- Interventions
- Diagnostic Test: EEG,PSGDiagnostic Test: biosample collection (blood and CSF)Diagnostic Test: neuropsychological testingDiagnostic Test: actigraphyDiagnostic Test: clinician assessment
- Registration Number
- NCT05171725
- Lead Sponsor
- Neurological Institute of Athens
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sleep and Circadian Disorders EEG,PSG 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 Neurocognitive Disorders biosample collection (blood and CSF) 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 Sleep and Circadian Disorders clinician assessment 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 Neurocognitive Disorders EEG,PSG 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 Neurocognitive Disorders actigraphy 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 Healthy controls actigraphy 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 Sleep and Circadian Disorders biosample collection (blood and CSF) 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 Sleep and Circadian Disorders actigraphy 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 Sleep and Circadian Disorders neuropsychological testing 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 Epilepsy disorders EEG,PSG 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 Neurocognitive Disorders clinician assessment 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 Epilepsy disorders neuropsychological testing 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 Epilepsy disorders actigraphy 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 Neurocognitive Disorders neuropsychological testing 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 Epilepsy disorders clinician assessment 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 Healthy controls EEG,PSG 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 Healthy controls biosample collection (blood and CSF) 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 Epilepsy disorders biosample collection (blood and CSF) 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 Healthy controls clinician assessment 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 Healthy controls neuropsychological testing 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
- Primary Outcome Measures
Name Time Method Expert System Accuracy for the Assessment of Complex Brain Disorders 3 years 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.
Expert System Accuracy for the Management of Complex Brain Disorders 3 years 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.
- Secondary Outcome Measures
Name Time Method Examine safety of approved therapies for Complex Brain Disorders 3 years 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.
Prevalence co-occurrence of Complex Brain Disorders (Neurocognitive, Sleep, and Epilepsy disorders) 3 years Within each of the three types of CoBraD, examine the frequency of comorbidity of the other two following comprehensive diagnostic protocols
Examine efficacy of approved therapies for Complex Brain Disorders 3 years 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).
Trial Locations
- Locations (4)
Neurological Institute of Athens
🇬🇷Athens, Greece
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Sant Pau Memory Clinic
🇪🇸Barcelona, Spain
King's College London
🇬🇧London, United Kingdom