EEG Screening for Clinical Trials
EEG has an important part to play in the screening of potential volunteers for phase 1 clinical trials where safety and tolerability are the primary study objectives.
Where pre-clinical studies of drug candidates have indicated that there is the potential for the drug to stimulate epileptiform discharges or seizures, Sponsors are increasingly required by regulators to include an EEG assessment at screening.
Screening EEG is a screen for the absence of abnormal brain activity or put another way, a screen for normalcy in healthy individuals.
A detailed neurological history of individuals provides a basic picture by asking questions regarding brain injury, history of seizures, stroke, familial history of seizures and so on, but it is unable to detect anything underlying – the clinically silent abnormalities.
Using a standard EEG assessment protocol it is possible to detect an individual with potentially increase relative risk and therefore exclude them from the study.
What We Offer
The Science Behind works directly with Sponsors and CROs to provide a flexible solution for the deployment of EEG during the screening and recruitment process.
State of the art clinical EEG systems
Tried and tested standard EEG screening protocol
Experienced and trained technicians
EEG data processing for seizure detection
EEG interpretation by medically trained neurophysiologists
The Science Behind can help Sponsors and CROs with some of these challenges in Phase 1 trials by providing the tools and specialist expertise to answer key questions in relation to safety and efficacy when bringing novel drug candidates to human clinical trials.