- Data published in Scientific Reports confirms a low-burden visual evoked potential (VEP) assessment can beemployedacross multiple clinical trial sitesas an objective measure ofneuroplastic modulationinreal-worldclinical trials ofCNS therapies
/PRNewswire/ –Cumulus Neuroscience, a leading innovator in brain health technology for clinical trials, today announced the publication of its latest peer-reviewed paper in Scientific Reports: “A brief visual evoked potential (VEP) modulation assessment of experience-dependent plasticity recorded via wireless dry-EEG headset in Phase-1 clinical units.”
Neuroplasticity is the brain’s ability to reorganize its structure, functions, and connections in response to experience, injury, or disease.It allows the brain to change and adapt, for example, by creating new neural pathways to compensate for damage, learning new skills, or recovering from events like a stroke.
Modulation of the visual evoked potential (VEP) measured by electroencephalography (EEG) can be used as a non-invasive human correlate of neuroplasticity measures in pre-clinical animal models which use invasive intracranial EEG. Asdeficits in neuroplasticity are a corecharacteristic and a keytarget for novel therapy development in a range of psychiatric and neurodegenerative diseases,VEPmodulationis asafeand objective measure oftreatment mechanism and efficacy. However, conventional EEG is high-burden and time-consuming, which has limited adoption in clinical trials. Further, reliability of participant-level VEP modulation measures, even in highly controlled conditions, has historically been disappointing.
To address these challenges, Cumulus Neuroscience developed a VEP modulation assessment using the NeuLogiq®Platform, which includes a quick set-up dry EEG headset, and applied multiscale frequency-domain analyses to extract more precise measures of neuroplasticity. This novel low-burden assessment was validated in a laboratory research setting and deployed to two US-based clinical trials, including a total of 50 healthy participants.
Key findings from the trial include robust group-level effects: post-modulation P1 amplitude increased in both groups (Cohen’s d = 0.77, 0.78) and N1b amplitude decreased in the clinical study group (Cohen’s d = -0.52). Test/retest reliability of the recorded VEP waveforms approached thatreportedin the literature forfull-length assessment paradigms with lab-quality wet-EEG hardware. While timeseries-based test-retest reliability of the VEP modulation effect was low, it was substantially improved to moderate levels (someICCs ≥0.5) with a wavelet-based analysis.
“This study demonstrates that it is possible to measure neuroplasticity reliably in real-world clinical environments using a non-invasive, low-burden, scalable approach,”said Brian Murphy, Co-Founder and Chief Scientific Officer at Cumulus Neuroscience. “Our findings open the door to incorporating objective plasticity measures into early-phase CNS drug development, which could accelerate progress in treating neuropsychiatric and neurodegenerative disorders. By combining a brief VEP modulation paradigm with advanced frequency-domain analyses, we achieved meaningful improvements in reliability without increasing participant and clinical site burden. This is a critical step toward making neuroplasticity assessments practical for multi-site trials.”
The NeuLogiq VEP assessment achieves group-level assessment of neural plasticity withsignificantly reduced burden and costrelativeto standard measuresand could be readilyadoptedforsupporting stratification of patient cohorts, detecting ‘signs of life’ for CNS-targeted compounds in early clinical-stage neuropsychiatric drug development, and scaling to larger cohort studies.
“The ability to capture valid VEPs in clinical studies with easy-to-deploy technology and short sessions has the potential to transform how we assess the efficacy of new therapies in this space,” said Dr. David Walling, Chief Clinical Officer for CenExel -CNS and Principal Investigator for the study. “Historically, we have not had a way to directly measure neuroplasticity outside of animal models which require invasive techniques. We can now integrate non-invasive VEP measures into clinical study workflows, providing sponsors with objective biomarkers of target engagement and treatment effects early in development.”
About Cumulus Neuroscience
Cumulus Neuroscience is a global leader in brain health technology, providing the most advanced platform for multi-dimensional data collection in clinical trials. Our mission is to accelerate the development of treatments for neuropsychiatric and neurodegenerative disorders by delivering scalable, reliable, and regulatory-compliant solutions for measuring brain function in real-world settings.
For more information, visit www.cumulusneuro.com
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SOURCE Cumulus Neuroscience