Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders
NCT ID: NCT05171725
Last Updated: 2024-05-21
Study Results
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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RECRUITING
350 participants
OBSERVATIONAL
2021-04-01
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
concurrent overnight sleep study with full electroencephalography (in-lab or at home)
biosample collection (blood and CSF)
blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information
neuropsychological testing
paper and pencil, as well as tablet based cognitive testing
actigraphy
week long actigraphy assessment with concurrent sleep diary acquisition
clinician assessment
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
concurrent overnight sleep study with full electroencephalography (in-lab or at home)
biosample collection (blood and CSF)
blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information
neuropsychological testing
paper and pencil, as well as tablet based cognitive testing
actigraphy
week long actigraphy assessment with concurrent sleep diary acquisition
clinician assessment
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
concurrent overnight sleep study with full electroencephalography (in-lab or at home)
biosample collection (blood and CSF)
blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information
neuropsychological testing
paper and pencil, as well as tablet based cognitive testing
actigraphy
week long actigraphy assessment with concurrent sleep diary acquisition
clinician assessment
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
concurrent overnight sleep study with full electroencephalography (in-lab or at home)
biosample collection (blood and CSF)
blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information
neuropsychological testing
paper and pencil, as well as tablet based cognitive testing
actigraphy
week long actigraphy assessment with concurrent sleep diary acquisition
clinician assessment
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)
biosample collection (blood and CSF)
blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information
neuropsychological testing
paper and pencil, as well as tablet based cognitive testing
actigraphy
week long actigraphy assessment with concurrent sleep diary acquisition
clinician assessment
standard clinical assessment by an expert clinician in the respective field of brain disorders
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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Rabin Medical Center
OTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
King's College London
OTHER
Uppsala University
OTHER
Holistic IKE
UNKNOWN
National Technical University of Athens
OTHER
Evolution Projects
UNKNOWN
Engineering Ingegneria Informatica S.p.A.
UNKNOWN
SOFTWARE IMAGINATION & VISION SRL
UNKNOWN
Vrije Universiteit Brussel
OTHER
STICHTING LIBER
UNKNOWN
University of Edinburgh
OTHER
CyberEthics Lab. srls
UNKNOWN
Neurological Institute of Athens
OTHER
Responsible Party
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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
Rabin Medical Center
Petah Tikva, , Israel
Sant Pau Memory Clinic
Barcelona, , Spain
King's College London
London, , United Kingdom
Countries
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Central Contacts
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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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Study site
Other Identifiers
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EU-Horizon-2020-965422
Identifier Type: -
Identifier Source: org_study_id
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