Neuro Biomarkers, Home EEG Assessed in Upcoming Trial

(Media News, Flickr)

13 June 2023. A digital biomarkers company and developer of neuroscience analytics are collaborating on a study of EEG measurements and algorithms with a wearable device at home. The partnership and new clinical trial bring together Koneksa Health in New York and Beacon Biosignals Inc. in Boston, but intellectual property and financial terms of their agreement are not disclosed.

Koneksa discovers and produces digital biomarkers in research and clinical trials, particularly for remote data collection. The eight year-old company develops digital measurements and algorithms for biological indicators or biomarkers integrated into a data collection system that connects study participants directly to researchers. In January 2023, Science & Enterprise reported on Koneksa’s collaboration with biologics maker Regeneron on a clinical trial that compares lung function measures in people with asthma using portable ultrasound and mobile app at home to conventional tests in a clinic.

Most of Koneksa’s digital biomarkers are in neuroscience. The company’s neurological biomarkers measuring walking gait, tremor, and vocal abilities are in clinical trials with drug makers and research charities, with other measures of sleep, tremors, and electroencephalogram or EEG measures of brain activity in preclinical stages. An EEG test tracks changes in brain activity, for diagnosing neurological conditions such as epilepsy, stroke, head trauma, and sleep disorders. EEGs are usually taken in a clinic with electrodes placed on the skull that read electrical signals from the brain.

Digital biomarkers for sleep and other disorders

Beacon Biosignals is a four year-old enterprise developing artificial intelligence algorithms for analyzing EEG data. The company says its deep learning algorithms are trained with large-scale and diverse databases from neurology, psychiatry, and sleep medicine. Those data sets, says the company, store data from some 30,000 patients, both with and without neurological diseases, plus 3.8 million expert annotations. In addition, says Beacon Bio, its algorithms are designed to process digital signals and predict an expert consensus, for more accurate and reliable recommendations than relying on a single assessment. The company’s technology is based on research by its founders at Harvard Medical School and MIT.

Koneksa and Beacon Bio are collaborating on a clinical trial to evaluate an EEG device used at home. The trial, not yet listed on the U.S. government’s clinical trial registry ClinicalTrials.gov, is an observational study to discover digital biomarkers for measuring sleep and other neurological disorders, and determine the usability and validity of those indicators with a home EEG device, other wearables, and smartphones. Koneksa says the trial with the acronym LEARNS — for a convoluted 30-word title — is recruiting patients with narcolepsy, obstructive sleep apnea, Alzheimer’s disease, Parkinson’s disease, and other neurological disorders.

Koneksa and Beacon Bio plan to syndicate participation in the trial to other companies. “The LEARNS study seeks to generate evidence to extend the Koneksa solution to new digital modalities and diseases,” says Koneksa’s chief medical officer John Wagner in a company statement released through BusinessWire, adding “Our goal is to provide the widest possible range of validated, scalable digital measures to sponsors in one platform.”

Christine Vietz, chief R&D officer at Beacon Bio notes, “This opportunity will expand the reach of Beacon’s EEG-based precision neurodiagnostics to more sponsors, and will provide critical validation of methodology that we believe could be transformational to patients.”

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