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

NCT05171725 | Completed DMC

• 1 other identifier: EU-Horizon-2020-965422
• Study Type: observational
• Target: 635
• Locations: 4 countries
• Sites: 4

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.

Conditions

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

Keywords

artificial intelligence; expert systems; deep-phenotyping

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Examine safety of approved therapies for Complex Brain Disorders

  3 years

• Prevalence co-occurrence of Complex Brain Disorders (Neurocognitive, Sleep, and Epilepsy disorders)

  3 years

• Examine efficacy of approved therapies for Complex Brain Disorders

  3 years

Study Arms (4)

Sleep and Circadian Disorders

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

Neurocognitive Disorders

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

Epilepsy disorders

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

Healthy controls

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

Interventions

EEG,PSG DIAGNOSTIC_TEST

concurrent overnight sleep study with full electroencephalography (in-lab or at home)

Epilepsy disorders; Healthy controls; Neurocognitive Disorders; Sleep and Circadian Disorders

biosample collection (blood and CSF) DIAGNOSTIC_TEST

blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information

Epilepsy disorders; Healthy controls; Neurocognitive Disorders; Sleep and Circadian Disorders

neuropsychological testing DIAGNOSTIC_TEST

paper and pencil, as well as tablet based cognitive testing

Epilepsy disorders; Healthy controls; Neurocognitive Disorders; Sleep and Circadian Disorders

actigraphy DIAGNOSTIC_TEST

week long actigraphy assessment with concurrent sleep diary acquisition

Epilepsy disorders; Healthy controls; Neurocognitive Disorders; Sleep and Circadian Disorders

clinician assessment DIAGNOSTIC_TEST

standard clinical assessment by an expert clinician in the respective field of brain disorders

Epilepsy disorders; Healthy controls; Neurocognitive Disorders; Sleep and Circadian Disorders

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study aims to develop an Expert System for the assessment and management of complex brain disorders in real-world practice and participants who present in all of the above clinics are eligible, in order to obtain data as close to real-world practice as possible.

You may qualify if:

• All participants willing to undergo comprehensive assessment who visit one of three clinics (Epilepsy, Neurocognitive disorders, and Sleep Disorders), and healthy volunteers

You may not qualify if:

• participant disinterest

Sponsors & Collaborators

• Neurological Institute of Athens: lead
• Rabin Medical Center: collaborator
• King's College London: collaborator
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Uppsala University: collaborator
• Holistic IKE: collaborator
• National Technical University of Athens: collaborator
• Evolution Projects: collaborator
• Engineering Ingegneria Informatica S.p.A.: collaborator
• SOFTWARE IMAGINATION & VISION SRL: collaborator
• Vrije Universiteit Brussel: collaborator
• STICHTING LIBER: collaborator
• University of Edinburgh: collaborator
• CyberEthics Lab. srls: collaborator

Study Sites (4)

Neurological Institute of Athens

Athens, Greece

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Sant Pau Memory Clinic

Barcelona, Spain

Location

King's College London

London, United Kingdom

Location

Related Links

• Study site

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma and serum) and CSF biosamples collected and retained in deep freeze.

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Epilepsy; Sleep Wake Disorders; Chronobiology Disorders

Interventions

Blood Specimen Collection; Actigraphy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Monitoring, Physiologic; Accelerometry

Study Officials

• Elissaios Karageorgiou

  Neurological Institute of Athens

  STUDY DIRECTOR

• Ioannis Stavropoulos

  King's College London

  STUDY DIRECTOR

• Ophir Keret

  Rabin Medical Center

  STUDY DIRECTOR

• Juan Fortea

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: December 29, 2021
• Study Start: April 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: an estimated 6 months after study completion
• Access Criteria: These will be developed upon completion of the Platform. The platform will contain both opensource and pre-existing proprietary code, and some of the code will not be made available to researchers, but will be functional on the Platform.

Locations

ES (1); IL (1); GR (1); GB (1)