Clinical trial NCT05171725: Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders
Official title: Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia
Alzheimer Disease
Epilepsy
Sleep Disorder
Circadian Rhythm Disorders
Healthy
Keywords: artificial intelligence
expert systems
deep-phenotyping
Lead sponsor: Neurological Institute of Athens
Sponsor class: OTHER
Collaborators: name: Rabin Medical Center
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: King's College London
name: Uppsala University
name: Holistic IKE
name: National Technical University of Athens
name: Evolution Projects
name: Engineering Ingegneria Informatica S.p.A.
name: SOFTWARE IMAGINATION & VISION SRL
name: Vrije Universiteit Brussel
name: STICHTING LIBER
name: University of Edinburgh
name: CyberEthics Lab. srls
First posted: 2021-12-29
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Expert System Accuracy for the Assessment of Complex Brain Disorders
timeFrame: 3 years
measure: Expert System Accuracy for the Management of Complex Brain Disorders
timeFrame: 3 years
Secondary outcomes:
measure: Examine safety of approved therapies for Complex Brain Disorders
timeFrame: 3 years
measure: Prevalence co-occurrence of Complex Brain Disorders (Neurocognitive, Sleep, and Epilepsy disorders)
timeFrame: 3 years
measure: Examine efficacy of approved therapies for Complex Brain Disorders
timeFrame: 3 years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Neurological Institute of Athens
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Barcelona
country: Spain
facility: Sant Pau Memory Clinic
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: Neurological Institute of Athens
name: Elissaios Karageorgiou
role: STUDY_DIRECTOR
affiliation: King's College London
name: Ioannis Stavropoulos
role: STUDY_DIRECTOR
affiliation: Rabin Medical Center
name: Ophir Keret
role: STUDY_DIRECTOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Juan Fortea
role: STUDY_DIRECTOR
References: