EEG Biomarker Portfolio
Biotrial’s Core Lab team comprises of expert professionals who specialize in supporting clinical sites across the globe with EEG measurements. This includes providing devices, training site staff to perform recordings, supporting the sites throughout the trial, and centrally analyzing the data captured.
EEG endpoints that can be centrally managed include:
| Domain | Test/Marker | Measure | |
|---|---|---|---|
| Resting EEG | qEEG Seizure & Spike detection and quantification Qualitative neurologist review | Safety assessment (neurologist) Spectral parameters (rel & abs power) | Brain maps Spectral ratios Source localization Functional connectivity |
| Event-Related Potentials | Cognitive potentials Auditory gating Gamma evoked Specifics upon request | P300 (oddball paradigm), Auditory Steady State Response Mismatch Negativity Memory (LMT), Error Related Negativity (flanker task) | P50, N100 Auditory Gating Sustained Attention to Response (SART) |
| Sleep EEG | PSG Sleep microstructure Spectral analysis Maintenance of Wakefulness Test | Sleep staging (ASSM 2007 or R&K) Apnea, Hypopnea, Arousals, Periodic movements, etc. | Spindle analysis: Count, Density, Position, Frequency, Amplitude, Duration, Power etc… |
| Preclinical EEG | Sleep Resting EEG ERP | Sleep scoring Spectral parameters Auditory Steady State Response | Seizure count |
Safety EEG
The objective of safety EEG is to not only observe study subjects for any pro-convulsive effects of the investigational drug, but also to evaluate trial participants for any pre-existing EEG abnormalities, such as seizures or spikes.
For certain participant profiles, there may be a need for qualitative reviews conducted by a neurologist to monitor the evolution of EEG signatures during a trial. These reviews may focus on specific elements such as interictal activity, background rhythm, slow waves, or other relevant factors.
Each recording is quality controlled by a specialized technician to ensure data quality (feedback and additional information or training are provided to study sites if required following this QC). After the QC step, we perform a semi-automated analysis during which the EEG is first automatically processed using specialized software; the result of this processing is then reviewed by a Neurologist. Results are reported back to the study sites and the sponsor and expert reports are provided at the end of a project or at specified times during the trial.
Examples of recording paradigms:
- Standard recording protocol of 20 to 40 minutes, including photic stimulation & hyperpnoea
- A long-duration, continuous recording lasting up to 48 hours. This is the gold standard to detect any epileptogenic activity
In order to explore the potential impact of a compound on brain function, a quantitative assessment of brain waves in different frequency bands can be performed.
This can enable our clients to:
- Establish proof of mechanism
- Define the compound’s EEG signature
- Compare to the action of existing known drugs
- Understand the physiological effects of their compound (drowsiness, cognition, etc…)
Example: Characterization of the CNS Effects of Benzodiazepines
Left graph: Time-frequency representation of Diazepam effect on rodents and reversal by Flumazenil.
Right graph: Cross-over study on 20 healthy volunteers administered with Lorazepam (brain mapping representation).
Event-Related Potentials
The EEG signal can vary when the subject is the object of a sensory, motor, or cognitive stimulus. The variations observed can be precisely measured using an adapted EEG setup and provide precious and useful information on the effect of the tested compound. Certain ERP signatures are specific and well described in the literature, providing documented biomarkers for clinical research. Common ERPs used include MisMatch Negativity (MMN), Auditory Steady-State Response (ASSR), or P300, however many paradigms may be set up.
Biotrial provides state-of-the-art services for these endpoints, providing specific equipment to not only record EEG but also to deliver the needed stimulus (auditory, visual or other) and record a response when needed.
Polysomnography (PSG)
PSG recordings can be used in order to investigate a compound’s effect on participants’ sleep. These recordings are performed overnight within a clinical setting and allow to determine a participants hypnogram as well as a full set of sleep parameters such as sleep latency, total sleep time, sleep efficiency, time per stage, WASO, etc…
In order to perform a PSG recording, in addition to EEG we record EOG, EMG, ECG and, for specific sleep apnea investigations it is also required to record breathing.
Clinical Site Support & Equipment
Biotrial’s Core Lab offers state-of-the-art equipment and continuous staff support specifically designed for clinical trials.
- Global shipment of EEG/PSG devices for collection of data
- Site training and 24/7 support for worldwide clinical sites
- Immediate replacement of any defective equipment
- Continuous quality monitoring of Data recordings with feedback to study sites
Biotrial’s fully–validated system ensures high-quality EEG recordings. The study-specific kits are user-friendly and allow for quick set-up at any clinical site (CPU or hospital) involved in a clinical trial. Our equipment supports standard EEG as well as advanced EEG-based assessments, such as PSG or ERP, in addition to 24h (or longer) ambulatory recordings.
EEG Analysis & Reports
EEG recordings are processed by our expert signal processing team. The Biotrial Core Lab uses validated signal processing tools and medical expertise to implement study data analyses:
- Qualitative reviews by board-certified neurologists
- qEEG: spectral analysis of the EEG recording, brain maps to provide a graphic representation of results
- ERP (auditory or visual event related potentials): brain mapping and graphical representations
- Polysomnography (sleep EEG): sleep scoring, spectral analysis, spindle analysis
- Exploratory analysis: study specific algorithm implementation
In order to ease the understanding and interpretation of the EEG signal and results, our team has developed a series of tools used to provide graphic, easy-to grasp representations of these results. These are reported back to the sponsor team at regular times during a project.
Data Management, Statistical Analysis & Report Writing
All activities are covered by Biotrial SOPs, guaranteeing data quality, process efficiency & compliance.
- Custom-made database set up and sponsor-specific data transfer protocols
- Statisticians & Medical Writers with extensive EEG experience
Consulting & Design Services
- Biotrial Experts can help you select the optimal EEG modality and the relevant assessment method for your project
- Animal EEG data can easily be generated in our preclinical facilities to support sponsor development strategies
- We offer interpretation of data and advice on the overall development plan for your compound.
