Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders (MES-CoBraD)
March 28, 2026 updated by: Neurological Institute of Athens
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
635
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Athens, Greece
- Neurological Institute of Athens
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Petah Tikva, Israel
- Rabin Medical Center
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Barcelona, Spain
- Sant Pau Memory Clinic
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London, United Kingdom
- King's College London
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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concurrent overnight sleep study with full electroencephalography (in-lab or at home)
blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information
paper and pencil, as well as tablet based cognitive testing
week long actigraphy assessment with concurrent sleep diary acquisition
standard clinical assessment by an expert clinician in the respective field of brain disorders
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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
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concurrent overnight sleep study with full electroencephalography (in-lab or at home)
blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information
paper and pencil, as well as tablet based cognitive testing
week long actigraphy assessment with concurrent sleep diary acquisition
standard clinical assessment by an expert clinician in the respective field of brain disorders
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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
|
concurrent overnight sleep study with full electroencephalography (in-lab or at home)
blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information
paper and pencil, as well as tablet based cognitive testing
week long actigraphy assessment with concurrent sleep diary acquisition
standard clinical assessment by an expert clinician in the respective field of brain disorders
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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
|
concurrent overnight sleep study with full electroencephalography (in-lab or at home)
blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information
paper and pencil, as well as tablet based cognitive testing
week long actigraphy assessment with concurrent sleep diary acquisition
standard clinical assessment by an expert clinician in the respective field of brain disorders
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Expert System Accuracy for the Assessment of Complex Brain Disorders
Time Frame: 3 years
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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.
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3 years
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Expert System Accuracy for the Management of Complex Brain Disorders
Time Frame: 3 years
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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.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Examine safety of approved therapies for Complex Brain Disorders
Time Frame: 3 years
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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.
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3 years
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Prevalence co-occurrence of Complex Brain Disorders (Neurocognitive, Sleep, and Epilepsy disorders)
Time Frame: 3 years
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Within each of the three types of CoBraD, examine the frequency of comorbidity of the other two following comprehensive diagnostic protocols
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3 years
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Examine efficacy of approved therapies for Complex Brain Disorders
Time Frame: 3 years
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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).
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Actual)
September 30, 2024
Study Completion (Actual)
September 30, 2024
Study Registration Dates
First Submitted
September 30, 2021
First Submitted That Met QC Criteria
December 18, 2021
First Posted (Actual)
December 29, 2021
Study Record Updates
Last Update Posted (Actual)
April 2, 2026
Last Update Submitted That Met QC Criteria
March 28, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurocognitive Disorders
- Tauopathies
- Neurodegenerative Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Alzheimer Disease
- Dementia
- Epilepsy
- Sleep Wake Disorders
- Chronobiology Disorders
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Monitoring, Physiologic
- Accelerometry
- Blood Specimen Collection
- Actigraphy
Other Study ID Numbers
- EU-Horizon-2020-965422
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be anonymized and depersonalized on a local site repository, and then uploaded in the secure MES-CoBraD Platform.
An estimated six months after study completion, data will be made available to other researchers through the MES-CoBraD Platform.
IPD Sharing Time Frame
an estimated 6 months after study completion
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.