F.A.Q
Frequently Asked Questions
General Overview of Theia
Theia is an AI-powered tool that helps healthcare professionals assess the risk of Mild Cognitive Impairment (MCI) in patients. It uses functional Near-Infrared Spectroscopy (fNIRS) to measure real-time changes in brain blood flow, and applies machine learning algorithms to generate a score indicating the likelihood of MCI.
Clinical trial. 2024 Data on file, Newmanbrain.
Theia is intended to provide clinicians with an adjunctive tool for the pre-screening of Mild Cognitive Impairment (MCI). It is designed to assess the likelihood of MCI in adults aged 60 to 85 years, but should not be used as a stand-alone diagnostic tool.
Newmanbrain technology can benefit:
Patients who wish to understand their cognitive health.
A wide array of healthcare providers (neurologists, psychiatrists, psychologists, gerontologists, nurses…).
Researchers and pharma, aiming to understand cognitive health, are providing data that may be used in research on brain-drug interactions.
Companies building AI-powered health solutions that may be interested in assessing or understanding cognitive health.
Yes, Theia is an award-winning medical device with global recognition for its innovation and design, including a Silver Award at the NY Product Design Awards 2024. It’s engineered for clinicians, researchers, and other healthcare professionals to assess cognitive health using functional near-infrared light. We aim to get CE marking in 2025.
Technology and AI-Powered Features
Theia® uses functional Near-Infrared Spectroscopy (FNIRS) to detect changes in oxy-hemoglobin (HbO) and deoxy-hemoglobin (HbR) levels in the prefrontal cortex during simple cognitive tasks. These measurements are analyzed through AI algorithms to generate a score that reflects the likelihood of MCI. Check out our “Science” page to learn more.
Theia leverages machine learning algorithms to analyze functional Near-Infrared Spectroscopy (fNIRS) data, comparing it against a database of patterns associated with Mild Cognitive Impairment (MCI) and healthy cognitive states. This AI-driven approach provides an objective and accurate assessment of cerebral hemodynamics.
Clinical trial. 2024 Data on file, Newmanbrain.
Clinical Pathway and Integration
Montreal Cognitive Assessment (MoCA) or Mini-Mental State Examination (MIS), are subjective and time-consuming. Theia provides an objective and fast assessment (under 20 minutes).
Data on file, Newmanbrain.
Theia is an accurate pre-assessment tool for Mild Cognitive Impairment (MCI) that helps clinicians determine the next steps in the diagnostic process.
Clinical trial. 2024 Data on file, Newmanbrain.
By offering a fast, accurate, and objective MCI assessment, Theia streamlines the diagnostic process, helping to identify individuals at risk for MCI.
Clinical trial. 2024 Data on file, Newmanbrain.
Theia supports early detection of Mild Cognitive Impairment (MCI), which is crucial for preventing or slowing the progression to dementia.
Theia is portable and can be used in various settings, including hospitals, outpatient clinics, and physicians’ offices.
Clinical Validation and Performance
Yes, Theia has undergone clinical validation through a study conducted in 2024, which demonstrated high sensitivity, specificity, and predictive value. The device successfully differentiated between MCI patients and healthy individuals with high accuracy. The device is intended to provide adjunct information to established cognitive assessments and is not intended to provide a stand-alone diagnosis for MCI.
Clinical trial. 2024 Data on file, Newmanbrain.
Theia showed:
- Sensitivity: 75%
- Specificity: 94%
- Positive Predictive Value (PPV): 92% (with 50% MCI prevalence)
- Negative Predictive Value (NPV): 94% (with 18% MCI prevalence)
- Area Under the Curve (AUC): 92.6%
These results indicate excellent performance in distinguishing MCI from healthy individuals. Nevertheless, Theia is not intended to provide stand-alone diagnosis for MCI. Currently, no diagnostic test or technique on the market can be used alone to diagnose MCI or dementia.
Clinical trial. 2024 Data on file, Newmanbrain.
Botello-Marabotto M, Martínez-Bisbal MC, Calero M, et al. Non-invasive biomarkers for mild cognitive impairment and Alzheimer’s disease. Neurobiology of Disease. 2023;187(106312). doi: https://doi.org/10.1016/j.nbd.2023.106312
Theia demonstrated a high accuracy in detecting Mild Cognitive Impairment (MCI), with a sensitivity of 75% and specificity of 94%. Literature suggests Theia may offer improved sensitivity/specificity compared to current neuropsychological tests in identifying MCI.
Clinical trial. 2024 Data on file, Newmanbrain.
Device Specifications and Usage
Theia is intended for use in adults aged 60 to 85 years, the age group with the highest prevalence of Mild Cognitive Impairment (MCI).
The test typically takes under 20 minutes, making it a quick and efficient tool for healthcare providers.
Data on file, Newmanbrain.
Theia is designed to facilitate broad patient participation in clinical trials by using simple arithmetic tasks that require only basic reading skills, making it accessible to individuals with diverse educational backgrounds.
The patient wears a lightweight, non-invasive headset and completes a series of simple tasks while sitting on a chair. It is non-invasive, fast, and hustle-free as the patient does not need to wear gels on the scalp or be in claustrophobic environments.
Regulatory and Compliance Considerations
Currently, Theia is for research purposes only. Newmanbrain aims to get CE-marking, ensuring it meets the European Union’s health, safety, and environmental protection standards for medical devices in 2025.
Theia complies with GDPR regulations, ensuring that all patient data is securely stored, anonymized, and processed to maintain patient confidentiality and privacy.
Theia is intended only for research purposes until further regulatory approvals are obtained.
Usage and requirements
Theia requires the installation of its application on a computer that meets the minimum system requirements. You can use an existing PC, as long as it is compatible. If your current setup doesn’t meet the requirements, a new computer will be needed to ensure optimal performance. If you need more information about system requirements, please contact us.
Although Theia is an easy-to-use platform, a little extra hand on how to get started is always welcome. We offer clear instructions during the patient’s evaluation and a detailed user manual in case you want to check the full documentation for more details.
Purchases, subscriptions and Payment options
Theia is available for research purpose only. Get in touch with us to get more information.
The device is expected to receive CE-marking in the upcoming months, ensuring its compliance with European Union standards and making it available for purchase in Europe. You can sign-up for pre-orders and we will let you know as soon as the device is available in your region.