Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders (MES-CoBraD)

Neurological Institute of Athens

Status: Enrolling

Conditions: Healthy; Alzheimer Disease; Epilepsy; Sleep Disorder; Circadian Rhythm Disorders; Dementia

Treatments: Diagnostic Test: actigraphy; Diagnostic Test: neuropsychological testing; Diagnostic Test: clinician assessment; Diagnostic Test: biosample collection (blood and CSF); Diagnostic Test: EEG,PSG

Study type: Observational

Funder types: Other

Identifiers

NCT05171725

EU-Horizon-2020-965422

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

350 participants in 4 patient groups

Sleep and Circadian Disorders

Description:

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

Treatment:

Diagnostic Test: actigraphy

Diagnostic Test: neuropsychological testing

Diagnostic Test: EEG,PSG

Diagnostic Test: clinician assessment

Diagnostic Test: biosample collection (blood and CSF)

Neurocognitive Disorders

Description:

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

Treatment:

Diagnostic Test: actigraphy

Diagnostic Test: neuropsychological testing

Diagnostic Test: EEG,PSG

Diagnostic Test: clinician assessment

Diagnostic Test: biosample collection (blood and CSF)

Epilepsy disorders

Description:

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

Treatment:

Diagnostic Test: actigraphy

Diagnostic Test: neuropsychological testing

Diagnostic Test: EEG,PSG

Diagnostic Test: clinician assessment

Diagnostic Test: biosample collection (blood and CSF)

Healthy controls

Description:

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

Treatment:

Diagnostic Test: actigraphy

Diagnostic Test: neuropsychological testing

Diagnostic Test: EEG,PSG

Diagnostic Test: clinician assessment

Diagnostic Test: biosample collection (blood and CSF)