Alzheimer Disease, Circadian Rhythm Disorders, Dementia, Epilepsy, Healthy, Sleep Disorder
Conditions
Keywords
artificial intelligence, expert systems, deep-phenotyping
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.
Interventions
DIAGNOSTIC_TESTEEG,PSG
concurrent overnight sleep study with full electroencephalography (in-lab or at home)
DIAGNOSTIC_TESTbiosample collection (blood and CSF)
blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information
DIAGNOSTIC_TESTneuropsychological testing
paper and pencil, as well as tablet based cognitive testing
DIAGNOSTIC_TESTactigraphy
week long actigraphy assessment with concurrent sleep diary acquisition
DIAGNOSTIC_TESTclinician assessment
standard clinical assessment by an expert clinician in the respective field of brain disorders
Sponsors
Neurological Institute of Athens
Rabin Medical Center
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
King's College London
Uppsala University
Holistic IKE
National Technical University of Athens
Evolution Projects
Engineering Ingegneria Informatica S.p.A.
SOFTWARE IMAGINATION & VISION SRL
Vrije Universiteit Brussel
STICHTING LIBER
University of Edinburgh
CyberEthics Lab. srls
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expert System Accuracy for the Assessment of Complex Brain Disorders | 3 years | 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. |
| Expert System Accuracy for the Management of Complex Brain Disorders | 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Examine safety of approved therapies for Complex Brain Disorders | 3 years | 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. |
| Prevalence co-occurrence of Complex Brain Disorders (Neurocognitive, Sleep, and Epilepsy disorders) | 3 years | Within each of the three types of CoBraD, examine the frequency of comorbidity of the other two following comprehensive diagnostic protocols |
| Examine efficacy of approved therapies for Complex Brain Disorders | 3 years | 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). |
Countries
Greece, Israel, Spain, United Kingdom
Contacts
STUDY_DIRECTORElissaios Karageorgiou
Neurological Institute of Athens
STUDY_DIRECTORIoannis Stavropoulos
King's College London
STUDY_DIRECTOROphir Keret
Rabin Medical Center
STUDY_DIRECTORJuan Fortea
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Outcome results
None listed