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Quantifying Drug Effects on Brain Activity


Quantitative electroencephalography (qEEG) is particularly well suited to Phase I clinical trials. It is a non-invasive and easy to deploy method of obtaining indications of blood brain barrier penetration and target engagement and is easily translatable from animal models. It can also be combined with other modalities to provide a more in-depth dose response and safety profile.

Safety Screening

Enhance volunteer selection by including an EEG safety screen as part of the trial screening and recruitment process. Where medical history of seizures and Epilepsy may not detect anything, this standardised diagnostic procedure is an easy to deploy and cost effective method of reducing variability of non-normal EEG results by excluding those where clinically silent abnormalities have been identified.

EEG has an important part to play in the screening of potential volunteers for Phase I clinical trials where safety and tolerability are the primary study objectives.

Where pre-clinical studies have indicated there is the potential for the drug to stimulate epileptiform  discharges or seizures, Sponsors are increasingly required by regulators to include EEG assessment at screening.

Screening EEG is a screen for the absence of abnormal brain activity or put another way 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 detent an individual with potentially increased relative risk and therefore exclude them from the study.

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.

Safety Monitoring

For new compounds where there is known preclinical risk to the brain, safety monitoring using EEG at baseline and during trial is an efficient way of evaluating that risk and therefore contributing to a more thorough understanding of the compound’s safety profile in humans.

EEG Event Related Potentials

Event Related Potentials (ERPs) are an EEG time locked measure of the brain’s activity in response to a specific stimulus whether cognitive, sensory or motor. ERPs are useful in tracking the effects of a compound on a range of CNS indications including Schizophrenia, Alzheimer’s Disease, Parkinson’s Disease and rare diseases such a Fragile X Syndrome and MEAK.

What We Offer

  • State of the art EEG systems
  • Tried and tested standard EEG protocols and procedures
  • Experiences and trained technicians
  • EEG data processing
  • EEG interpretation by medically trained neurophysiologists

Advantages of Pharmaco-EEG

  • Cost effective and easily to integrate into a Phase I clinical trial
  • Provides an objective measure to real time brain response
  • Can be easily combined with other modalities including cognitive tasks and assessments, TMS and motor tasks so is useful for providing markers of efficacy across a wide range of CNS indications
  • Can offer insights relating to off-target effects, potentially opening the door to other avenues of opportunity or curtailing unfruitful future investment
  • Is safe and non-invasive

Frequently Asked Questions

Why is EEG safety screening important in Phase I clinical trials?

EEG safety screening is crucial in Phase I clinical trials to ensure the safety and tolerability of new drug candidates. It helps detect individuals with abnormal brain activity, reducing the risk of adverse events. This screening is particularly important when pre-clinical studies indicate a potential for the drug to stimulate epileptiform discharges or seizures, as required by regulatory bodies

What are the advantages of EEG over other imaging techniques such as MRI, PET or MEG?

EEG offers several advantages over other imaging techniques like MRI, PET, and MEG:
Temporal Resolution: EEG provides superior temporal resolution, capturing brain activity in real-time, which is essential for studying dynamic brain processes.
Non-Invasive and Safe: EEG is non-invasive and poses no exposure to radiation or strong magnetic fields, making it safe for repeated use.
Cost-Effective: EEG is generally more cost-effective compared to MRI and PET, allowing for broader and more frequent application in clinical trials.
Ease of Use: EEG equipment is portable and easier to set up, enabling use in a variety of settings, including bedside monitoring and outpatient environments.
Direct Measurement of Neural Activity: EEG directly measures electrical activity of the brain, offering a direct insight into neuronal function, unlike MRI and PET which measure indirect markers of brain activity.

What services do The Science Behind offer for EEG in clinical trial?

The Science Behind offers state-of-the-art EEG systems, standard EEG protocols and procedures, experienced and trained technicians, EEG data processing, and interpretation by medically trained neurophysiologists. These services ensure accurate and comprehensive EEG assessments for your clinical trials.

Should I include qEEG, ERP or both in my clinical trial?

Our team of experts will assist you in designing and implementing the correctly tailored EEG protocol, ensuring precise and reliable assessment of brain activity.

How can I incorporate qEEG into my clinical trial?

The optimal frequency and timing of EEG assessments in your clinical trial depend on the specifics of your compound, trial design, and endpoints. At a minimum, it is recommended to perform EEG assessments during screening, at baseline, and at least once post-dose. For tailored advice on incorporating EEG into your clinical trial, please contact us.

Additional Resources

Neural synchronisation deficits linked to cortical hyper-excitability and auditory hypersensitivity in Fragile X Syndrome – annotated. (Etheridge et al 2017)

Want to Know More?

To learn more about how Pharmaco-EEG could benefit your Phase I clinical trial contact us. Our team of experts is ready to provide detailed information and assist you in designing the most effective and comprehensive assessment plan for your study.