A clinical trial will investigate the integration of neurodiagnostic company Beacon Biosignals’ at-home electroencephalogram (EEG) into digital biomarkers company Koneksa’s Neuroscience Solution Toolkit to discover biomarkers and determine the usability and validity of measures of sleep and neurologic disorders collected using at-home EEG, wearables, and smartphones.

The Koneksa-sponsored clinical validation study, “A basket observational study to determine usability, analytical validity, clinical validity, and biomarker discovery for at-home EEG, wearable, and mobile device collected objective measurement of disturbed sleep and neurologic disorders (LEARNS),” will investigate the Koneksa neuroscience solution, as well as the Beacon Biosignals platform, applied to at-home EEG, compared with in-clinic polysomnography, in sleep and neurological disorders. 

The Beacon platform unlocks longitudinal, at-home EEG technology, applies machine-learning algorithms to maximize insights into brain activity, and empowers sponsors with comprehensive data analysis and data visualization capabilities, according to a release from Koneksa.

“The utilization of evidence-based digital biomarkers is the key to transforming healthcare,” says Chris Benko, CEO of Koneksa, in a release. “We’re on a mission to revolutionize drug development in clinical trials by harnessing the power of our digital solutions with real-time, data-driven insights. Our collaboration with Beacon Biosignals will enable sponsors to integrate our digital solutions into clinical trials to identify treatment signals earlier and faster than with traditional measures.”

Current cohorts in the LEARNS study include Parkinson’s disease, narcolepsy, obstructive sleep apnea, Alzheimer’s disease, Huntington’s disease, and mild cognitive impairment.

“The LEARNS study seeks to generate evidence to extend the Koneksa solution to new digital modalities and diseases,” said John Wagner, MD, PhD, Chief Medical Officer, Koneksa. “Beacon’s mobile EEG will join more than a dozen digital health technologies that are already integrated into the Koneksa solution. Our goal is to provide the widest possible range of validated, scalable digital measures to sponsors in one platform.”

The LEARNS study will measure the validity of smartphone-based motor, speech, and cognitive assessments versus gold-standard tools. The study will also evaluate whether assessment combinations can identify diagnostic features at the cohort diagnostic boundary. 

“We are excited to partner with Koneksa on the LEARNS trial. 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,” says Christine Vietz, PhD, Beacon’s chief research and development officer, in a release.

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