Data collection and analysis services for drug safety
and neurological or psychiatric disease applications
SEIZURE DERISKING IN DRUG DEVELOPMENT
SEIZURES AND DRUG DEVELOPMENT
Seizures are defined by abnormal synchronous electrical activity of populations of neurons. Although behavioral and clinical features of seizure vary, their underlying trigger is always an escalating synchronization of neuronal activity that can begin prior to convulsive events. Depending on its epicenter and nature, the manifestation of a seizure can range from subtle signs to severe convulsions. EEG remains the gold standard for preclinical and clinical assessment of seizures. EEG studies can identify a liability early in development, allowing for fast decisions and cost savings.
Our analyses of preclinical acute EEG or telemetry/video-EEG follow established tenets for the assessment of neuropharmacologic effects and is aligned with the neurology clinical practice and ILAE (The International League Against Epilepsy) classifications for seizures, status epilepticus, and interictal discharges indicative of increased risk of seizure (spikes, sharp waves, abnormal slowing, etc.). Our clinical EEG analyses involve direct and automated searches and expert neurologist data reads.
PRECLINICAL EEG BIOMARKERS
EEG Biomarkers (qEEG)
EEG biomarkers provide early, translatable, and cost effective prediction of drug effects or disease model EEG 'fingerprinting'. In support of preclinical trials, we offer EEG data collection and analyses in multiple species, based on project requirements.
Our state of the art signal analysis includes spectral features, functional connectivity, and brain mapping, including EEG biomarker applications in primates based on 19-channel EEG.
CLINICAL EEG BIOMARKERS
qEEG Biomarkers in Clinical Trials
Selection of robust clinical endpoints
Protocol and site setup support
Fast EEG data analyses and reports
Surface and deep structure functional connectivity
LORETA (Low-Resolution Brain Electromagnetic Tomography) EEG source correlation
Symptom-based hypothesis testing
Normative database comparison
Statistical topographical maps
Cognitive testing / neurophysiological correlates
I am very impressed with both the quality of processing and the interpretation of preclinical EEG findings. I have great respect for the work that Dr. Metea has done – she is one of the most highly knowledgeable scientists in this field.
Joseph Arezzo, Ph.D.
Professor of Neuroscience and Neurology
Albert Einstein College of Medicine
The quality of EEG analyses and overall study coordination was outstanding. We were able to make fast decisions and advance our program for a CNS-active small molecule.
Project Lead, Pharma, MA
Fast, complete, qEEG reports with added competent recommendations for brain training in addition to thorough analyses. I appreciated the availability of several experts when I had questions. Thanks!
Licensed Clinical Psychologist, TX
In vitro CRO
Monica's expertise helped us validate a novel in vitro electrophysiological system with complex neurobiology. We were unable to interpret some of our results, and she helped us add more robust analysis packages. Now we have further engaged her to design technology upgrades to automate our processes.
Lowry Curley, CEO, Axosim