EEG Clinical Trials Services
Advanced Brain Monitoring provides full service EEG for clinical trials using the StatX Series wireless EEG systems administered concurrently with a full suite of tasks, including resting state and event-related related protocols. Stat X24 combines rapid application, low patient burden and disposable materials with high quality EEG acquisition easily performed in a clinical or home setting. Our team has expertise in customized quantitative EEG analysis, biomarker development and implementation, and support of international investigational drug clinical trials. Biomarker specializations include Alzheimer’s and dementia, Parkinson’s and basal ganglia disorders, mood disorders and other neurodegenerative and neuropsychiatric diseases.
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Servcies Overview
Wireless, easy to apply StatX 24 EEG systems and laptops shipped to global clinical sites
- Stat X24 EEG systems provide 20 channels of EEG in the standard international 10-20 montage, and an optional channel to allow recording of EOG, ECG or EMG.
- Systems are FDA cleared, and CE marked, lightweight, portable and easily scalable for Phase 1 to Phase 4 clinical trials.
- Secure data transfer via cloud portal is HIPAA and FDA compliant.
- Laptops are loaded with customized software, synced to EEG systems via Bluetooth, tested and validated prior to shipment.
- EEG strips and sensors are available pre-assembled and disposable for convenience, hygiene, and added safety of the patients and clinical staff.
- Portable systems are suitable for acquisition in a variety of settings including clinic, office or home.
Customized software development
- Full suite of resting state, sustained attention and memory tasks available
- Translation of tasks and training materials to any language available
Continuous Study Support
- ABM staff provides global 24 hour/7 day clinical site support
- Rapid data quality feedback
- Any language accommodated
Awake EEG custom analysis capabilities and interpretation of results
- Quantitative EEG (QEEG): Power spectral densities at 1Hz bins or standard bands
- Source localization using low resolution electromagnetic tomography (LORETA)
- Functional connectivity using EEG coherence and phase delay
- Comparison to age-matched normative, neurodegenerative, or neuropsychiatric databases
- Pharmacodynamics in response to drug – PK/PD analysis performed
- ERPs in response to tasks designed to elicit neural circuitry associated with cognitive processes including sustained attention, image recognition and working memory
- Waveforms compared between cohorts for full head map
- Relevant components identified, measured and compared between cohorts.
Training and Certification
- Customized website provided with 15 minute instructional video and training documents
- Hands-on individual training for assembly of the system, application to the participant, acquiring EEG data and system break down and uploading data
- Short proficiency quiz
- Practicum: full mock EEG acquisition is performed and evaluated by an ABM representative
HIPAA and 21 CFR Part 11 compliant cloud-based portal for data transfer and management
- Data is protected by encryption on the clinical site laptop
- Secure data transfer to a cloud based, password protected portal
- Portal access to CRO and sponsor available
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