What is Pharmaco-EEG?
Electroencephalography (EEG) 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 detect 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.
What we offer
State of the art EEG systems
Tried and tested standard EEG protocols and procedures
Experienced and trained technicians
EEG data processing and quality control
qEEG
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.
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.
Advantages for Phase I clinical trials
- Cost effective and easy to integrate into a Phase I clinical trial.
- Provides an objective measure of real time brain response.
- 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.
- Offers 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.
Clinical research services
Protocol design
We understand that effective protocol design is crucial for obtaining valuable insights into drug effects, thereby de-risking and guiding future pipeline decisions. Our neuroscience research consultants, with decades of combined experience, specialise in designing and developing scientifically rigorous protocols for electroencephalography (EEG).Integrated solutions
From quantitative EEG measurement to safety monitoring, we offer a comprehensive range of integrated, non-invasive solutions to stimulate and image specific brain regions, which are crucial for objectively understanding neural pathways and exploring therapeutic interventions.Resourcing for data acquisition
Adhering to standard operating procedures and good clinical practice, we deploy highly trained and experienced neuroscience researchers and technicians to every clinical trial. Each team member is thoroughly trained on the specific technology solutions and the study’s data acquisition protocol. At the heart of this training is a commitment to consistently high-quality EEG data acquisition.Data analysis and interpretation
Analysing and interpreting neuroscience data requires a deep understanding of complex neural systems and the techniques and technology used to capture this information. Our neuroscience research consultants, with backgrounds in clinical and scientific research, are highly skilled in developing and utilising specialised analysis pipelines for both single and multi-modal neuroscience data.Technical support
With over 15 years of hands-on experience in designing integrated non-invasive brain stimulation and imaging solutions for scientific research, our technical support specialists offer expertise in crafting technical solutions for each clinical trial. Once the trial begins, they are readily available to provide ongoing technical assistance, ensuring smooth operations with a focus on consistency and high-quality data acquisition.Bespoke services
Our team will collaborate with you to identify and select the appropriate tests and measures based on your drug candidate's mechanism of action, data from preclinical studies, and relevant academic and scientific literature. This approach allows us to create a tailored solution that provides meaningful and objective endpoints while seamlessly integrating with other clinical trial measurements. If you're interested in incorporating any of these services and would like to discuss further, please get in contact!Frequently asked questions
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.
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.
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 and/or research neurophysiologists. These services ensure accurate and comprehensive EEG assessments for your clinical trials.
Our team of experts will assist you in designing and implementing the correctly tailored EEG protocol, ensuring precise and reliable assessment of brain activity.
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.