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

NCT ID: NCT05171725

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-09-30

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.

Detailed Description

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Conditions

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Dementia Alzheimer Disease Epilepsy Sleep Disorder Circadian Rhythm Disorders Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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

EEG,PSG

Intervention Type DIAGNOSTIC_TEST

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

biosample collection (blood and CSF)

Intervention Type DIAGNOSTIC_TEST

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

neuropsychological testing

Intervention Type DIAGNOSTIC_TEST

paper and pencil, as well as tablet based cognitive testing

actigraphy

Intervention Type DIAGNOSTIC_TEST

week long actigraphy assessment with concurrent sleep diary acquisition

clinician assessment

Intervention Type DIAGNOSTIC_TEST

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

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

EEG,PSG

Intervention Type DIAGNOSTIC_TEST

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

biosample collection (blood and CSF)

Intervention Type DIAGNOSTIC_TEST

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

neuropsychological testing

Intervention Type DIAGNOSTIC_TEST

paper and pencil, as well as tablet based cognitive testing

actigraphy

Intervention Type DIAGNOSTIC_TEST

week long actigraphy assessment with concurrent sleep diary acquisition

clinician assessment

Intervention Type DIAGNOSTIC_TEST

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

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

EEG,PSG

Intervention Type DIAGNOSTIC_TEST

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

biosample collection (blood and CSF)

Intervention Type DIAGNOSTIC_TEST

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

neuropsychological testing

Intervention Type DIAGNOSTIC_TEST

paper and pencil, as well as tablet based cognitive testing

actigraphy

Intervention Type DIAGNOSTIC_TEST

week long actigraphy assessment with concurrent sleep diary acquisition

clinician assessment

Intervention Type DIAGNOSTIC_TEST

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

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

EEG,PSG

Intervention Type DIAGNOSTIC_TEST

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

biosample collection (blood and CSF)

Intervention Type DIAGNOSTIC_TEST

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

neuropsychological testing

Intervention Type DIAGNOSTIC_TEST

paper and pencil, as well as tablet based cognitive testing

actigraphy

Intervention Type DIAGNOSTIC_TEST

week long actigraphy assessment with concurrent sleep diary acquisition

clinician assessment

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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EEG,PSG

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

Intervention Type DIAGNOSTIC_TEST

biosample collection (blood and CSF)

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

Intervention Type DIAGNOSTIC_TEST

neuropsychological testing

paper and pencil, as well as tablet based cognitive testing

Intervention Type DIAGNOSTIC_TEST

actigraphy

week long actigraphy assessment with concurrent sleep diary acquisition

Intervention Type DIAGNOSTIC_TEST

clinician assessment

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

Intervention Type DIAGNOSTIC_TEST

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role collaborator

Holistic IKE

UNKNOWN

Sponsor Role collaborator

National Technical University of Athens

OTHER

Sponsor Role collaborator

Evolution Projects

UNKNOWN

Sponsor Role collaborator

Engineering Ingegneria Informatica S.p.A.

UNKNOWN

Sponsor Role collaborator

SOFTWARE IMAGINATION & VISION SRL

UNKNOWN

Sponsor Role collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role collaborator

STICHTING LIBER

UNKNOWN

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role collaborator

CyberEthics Lab. srls

UNKNOWN

Sponsor Role collaborator

Neurological Institute of Athens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elissaios Karageorgiou

Role: STUDY_DIRECTOR

Neurological Institute of Athens

Ioannis Stavropoulos

Role: STUDY_DIRECTOR

King's College London

Ophir Keret

Role: STUDY_DIRECTOR

Rabin Medical Center

Juan Fortea

Role: STUDY_DIRECTOR

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

Locations

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Neurological Institute of Athens

Athens, , Greece

Site Status RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Sant Pau Memory Clinic

Barcelona, , Spain

Site Status RECRUITING

King's College London

London, , United Kingdom

Site Status RECRUITING

Countries

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Greece Israel Spain United Kingdom

Central Contacts

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Athena Tsakopoulou

Role: CONTACT

+302107217457

Elissaios Karageorgiou

Role: CONTACT

+302107217457

Facility Contacts

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Athena Tsakopoulou

Role: primary

Ophir Keret

Role: primary

Javi Arranz

Role: primary

Ioannis Stavropoulos

Role: primary

Related Links

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Other Identifiers

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EU-Horizon-2020-965422

Identifier Type: -

Identifier Source: org_study_id

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