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

Healthy Clinical Trial

— MES-CoBraD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05171725
• Other study ID #: EU-Horizon-2020-965422
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Neurological Institute of Athens
• Contact: Athena Tsakopoulou
• Phone: +302107217457
• Email: a.tsakopoulou[@]nioa.gr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Brain Diseases
• Chronobiology Disorders
• Circadian Rhythm Disorders
• Dementia
• Epilepsy
• Healthy
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Greece	Neurological Institute of Athens	Athens
Israel	Rabin Medical Center	Petah Tikva
Spain	Sant Pau Memory Clinic	Barcelona
United Kingdom	King's College London	London

Sponsors (14)

Lead Sponsor	Collaborator
Neurological Institute of Athens	CyberEthics Lab. srls, Engineering Ingegneria Informatica S.p.A., Evolution Projects, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Holistic IKE, King's College London, National Technical University of Athens, Rabin Medical Center, SOFTWARE IMAGINATION & VISION SRL, STICHTING LIBER, University of Edinburgh, Uppsala University, Vrije Universiteit Brussel

Countries where clinical trial is conducted

Greece,  Israel,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expert System Accuracy for the Assessment of Complex Brain Disorders	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.	3 years
Primary	Expert System Accuracy for the Management of Complex Brain Disorders	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.	3 years
Secondary	Examine safety of approved therapies for Complex Brain Disorders	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.	3 years
Secondary	Prevalence co-occurrence of Complex Brain Disorders (Neurocognitive, Sleep, and Epilepsy disorders)	Within each of the three types of CoBraD, examine the frequency of comorbidity of the other two following comprehensive diagnostic protocols	3 years
Secondary	Examine efficacy of approved therapies for Complex Brain Disorders	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).	3 years

External Links

•   Study site