The Science Behind has supported a Phase 1 clinical safety and efficacy study for a neuroprotectant. Working directly with the CRO we were asked to provide EEG data acquisition and data interpretation as part of the volunteer recruitment and screening process as well as continuous EEG data acquisition and subsequent data analysis during dosing for the single and multiple ascending dose parts of the study. Our role was to look for indications of abnormal activity.
The key activities required were:
- On-site EEG data acquisition as the last stage of the volunteer screening process
- Design of a suitable EEG screening protocol to include/exclude volunteers on/from the trial
- On-site and ambulatory EEG data acquisition of volunteers during the dosing periods
- Qualified EEG technicians for data acquisition
- Qualified Clinical Neurologist for data review and interpretation.
The Science Behind provided a number of 21-Channel, mobile EEG devices, neuroscientific and clinical neurological expertise in order to design and deliver an EEG protocol which was deployed as part of the screening process to filter out volunteers that exhibited signs of abnormal neurological activity during specific stimulation conditions and to monitor volunteers’ EEG activity throughout each dosing period.
Over the study period we delivered, 100 EEG screens and 48 monitoring EEGs with all reports turned around on average within 24 hours following the EEG monitoring on-site.
As a result of this study, the Sponsor has been able to prepare for a Phase 2 trial.