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NCT Number: NCT05171725

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

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.

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Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Chronobiology Disorders Circadian Rhythm Disorders Epilepsy Healthy Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders Tauopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Neurological Institute of Athens, Athens, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG,PSG

Diagnostic Test

concurrent overnight sleep study with full electroencephalography (in-lab or at home)

biosample collection (blood and CSF)

Diagnostic Test

blood or CSF collection for analyses of neurodegenerative, inflammatory, and, per condition, genetic information

Neuropsychological testing

Diagnostic Test

paper and pencil, as well as tablet based cognitive testing

Actigraphy

Diagnostic Test

week long actigraphy assessment with concurrent sleep diary acquisition

clinician assessment

Diagnostic Test

standard clinical assessment by an expert clinician in the respective field of brain disorders

Primary outcomes

  1. Expert System Accuracy for the Assessment of Complex Brain Disorders

    Time frame: 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.

  2. Expert System Accuracy for the Management of Complex Brain Disorders

    Time frame: 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 outcomes

  1. Examine safety of approved therapies for Complex Brain Disorders

    Time frame: 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.

  2. Prevalence co-occurrence of Complex Brain Disorders (Neurocognitive, Sleep, and Epilepsy disorders)

    Time frame: 3 years

    Within each of the three types of CoBraD, examine the frequency of comorbidity of the other two following comprehensive diagnostic protocols

  3. Examine efficacy of approved therapies for Complex Brain Disorders

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Neurological Institute of Athens

Other

Collaborators

  • 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

Registry information

Acronym: MES-CoBraD

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2021
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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