EEG

Expertise & Impact for Successful EEG/PSG Studies

Electroencephalography (EEG) has gained prominence as an ideal biomarker as it is continuous, objective, repeatable, reproducible, sensitive, non-invasive and highly translatable from non-clinical data. EEG provides safety and PD outcomes for PK-PD modeling, enabling a deeper understanding of the pharmacological effects of the drug early in its development. Biotrial’s Core Lab offers a fully-validated combination of equipment and services to manage EEG capture in all phases of clinical development. With a solid track record and vast experience, Biotrial efficiently delivers high quality EEG data to support compound evaluation.

Characterization of the CNS Effects of Benzodiazepines

Time frequency representation of Diazepam effect on rodent and reversal by Flumazenil.

Cross-over study on 20 healthy volunteers administered with Lorazepam (brain mapping representation).

Services

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 non-clinical facilities to support sponsor development strategies 
  • We offer interpretation of data and advice on the overall development plan for your compound

 

Clinical Site Support & Equipment

Biotrial’s Core Lab offers state-of-the-art equipment and continuous staff support specifi cally 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 the EEG Data recordings, artifact rejection

 

EEG Analysis

EEG recordings are processed according to pre-defined procedures, compliant with the protocol requirements. The Biotrial Core Lab uses validated signal processing tools and medical expertise to implement study data analysis.

  • Safety EEG (including ILS): on-line safety review by board-certifi ed neurologists
  • qEEG: spectral analysis of the EEG recording, mapping
  • ERP (auditory or visual event related potentials)
  • Polysomnography (sleep EEG): sleep scoring, spectral analysis
  • Exploratory analysis: study specific algorithm implementation

 

Data Management, Statistical Analysis & Report Writing

All activities are covered by Biotrial SOPs, guaranteeing data quality, process effi ciency & compliance.

  • Custom-made database set up and sponsor-specific data transfer protocols
  • Statisticians & Medical Writers with extensive EEG experience

Details of EEG-derived Biomarkers

Domain Domain Test/Marker
Event-Related
Potentials
• Cognitive potentials
• Auditory gating
• Gamma evoked
• PrePulse Inhibition
• P300 (oddball paradigm), Memory (LMT), ERN (Flanker), etc.
• P50, N100
• Evoked and induced gamma
• Mismatch Negativity Potential Eye Blink (EMG)
Wake EEG • qEEG
• Spike detection
• Spectrum
• Flat Mapping
• Spectral ratios
• LORETA
• Connectivity
• Synchronization likelihood
Sleep EEG • PSG
• Sleep microstructure
• Spectral analysis
• PSG
• Sleep microstructure
• Spectral analysis

Any specific request is taken into consideration and implemented by Biotrial’s R&D team on our EEG platform.

Portable PD Equipment

The Biotrial Core Lab offers a fully-validated system for high quality EEG recording. This EEG kit is user friendly and allows a quick set up process at any clinical site (CPU or hospital site) enrolled in a clinical trial. The Biotrial Core Lab ensures that site staff is appropriately trained and provides full technical support during each study. Our equipment supports standard EEG as well as advanced EEG-based assessments such as PSG or ERP, in addition to 24h ambulatory recording.