UK-based digital health company Cumulus Neuroscience has developed a novel, user-friendly, dry-sensor electroencephalogram (EEG) synced device for self-directed use at home by patients or in a healthcare facility.
The dry-sensor EEG headset can be used by adult and adolescent patients for the remote acquisition, display and storage of EEG data, which is a recording of brain activity. It provides critical data and insights for clinical trials that will help deliver new therapies to patients quicker.
The neurophysiology platform can help clinical researchers expedite the advancement of treatments for neuropsychiatric and neurodegenerative disorders by offering dependable information spanning various aspects of brain operation, ranging from distinct disease indications to operational neurophysiology.
Cumulus Neuroscience received 510(K) clearance from the US Food and Drug Administration (FDA) for the EEG system in May this year. The approval marks the second medical device clearance for the headset following the UK Conformity Assessed marking secured in the country.
The existing version of the dry-sensor EEG headset was designed by PA Consulting to obtain clinical-grade data remotely to monitor and evaluate neurological activity.
Designed to improve the study and development of precision central nervous system medicines, the Cumulus EEG headset has received accolades from the iF Design Award and International Red Dot Competitions.
Cumulus dry-sensor headset design and details
The first-in-class Cumulus headset is available in four sizes and can be self-applied by users in just five minutes using the Cumulus mobile app, eliminating the need for support from an EEG technician or healthcare professional.
The EEG headset collects a large amount of real-world data and clinical data several times by synchronising with a tablet-based neuro-assessment platform.
The headset offers a way to initiate clinical trials remotely with data being sent to the Cumulus Medical Device Hub for healthcare professionals to instantly assess EEG recordings in real time.
The device allows secure cloud-based and machine learning architecture to analyse behavioural, physiological, and functional data in a secured environment.
Cumulus neurophysiology platform features
Cumulus’ functional neurophysiology platform contains a Cumulus headset that obtains data by placing electrodes on the heads of adults and adolescents.
The Cumulus software application runs on a mobile device running Android software. With the graphical interface, the software guides the user in appropriately placing the headset. The EEG data is transmitted from the headset via Bluetooth. The obtained data is synchronised and timestamped between the headset and the app.
The Cumulus Medical Device Hub provides the user interface for the healthcare team to view, download, and review data from the recordings.
The EEG sampling rate of dry electrodes is 250Hz and 500Hz, with 24 bits of resolution, a bandpass of 0.5Hz-50Hz, 1.6 µVp-p of noise, and an input voltage range of +/- 200mV.
The integrated platform of Cumulus is built on state-of-the-art technology that uses complex datasets to create new insights in five major measurement areas to show the effects of age, disease, and therapy. The platform is unified with medical-grade, at-home data, effective machine-learning analytics, and a real-time database of annotated, longitudinal, and matched data. Through its regular use, the device obtains longitudinal data through a wide range of domains, including neurophysiological monitoring.
The platform helps provide new cognitive dimensions in clinical trials, bringing patients novel, quick, and cost-effective therapies.
With the help of tablet-based, real-world translations of laboratory-based tasks, the patient’s cognitive abilities are evaluated from their home setting. The tasks are designed for frequent longitudinal assessment of working memory, episodic memory, executive function, decision-making, and other cognitive functions.
Additional features of the Cumulus platform
The Cumulus platform integrates P1vital Products’ Facial Expression Recognition Task (FERT) to assess emotional behaviour. P1vital offers computerised behavioural testing in clinical trials to examine mood and other psychiatric domains.
P1 FERT helps validate emotional information processing and indicates the patient’s current mood. FERT is useful for early detection of treatment response in both clinical trials and healthcare settings.
The Cumulus platform utilises Winterlight Labs’ state-of-the-art algorithms and database to assess word choice, grammar, and the acoustic properties of speech. Winterlight has developed a language-based diagnostic system that analyses natural speech to detect and monitor dementias, including Alzheimer’s, aphasia, and other cognitive conditions.
Integrated with sleep assessment tools, the platform enables remote measurement of sleep quality metrics and sleep staging.
AI-powered analytics enables the evaluation of multidimensional real-world data, providing meaningful insights automatically, and allowing for the detection of small and critical changes in a patient’s cognitive health.