Assessing Repeatability of NeuroCatch Platform™ Measurements: An Initial Assessment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03421405|
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : May 11, 2018
EEG signals have been collected and studied since the early 1990's as a way of assessing brain function at a gross level. As early as the 1930's a derivative of the raw EEG signal - event-related potentials (ERPs) - have been computed. These scalp-recorded ERPs are the brains response to a stimulus of interest (e.g. a flashing checkerboard or an angry face). The timing and topographical location of ERP components lends insight into the timing and complexity of various cognitive processes. At NeuroCatch Inc., research is primarily focused on three ERP components: the N100, P300 and N400.
To elicit the ERP components of interest in this study (N100, P300, N400), proprietary auditory stimulus sequences will be administered using the investigational device, the NeuroCatch Platform™. Each sequence consists of pure tones and word pairs to elicit the various components associated with different attention abilities (sensory processing, target detection & semantic processing). A secondary objective of the study will be to validate the auditory stimulus sequences tested.
Understanding the degree to which these neurophysiological components fluctuate over time is crucial to our understanding of typical brain functioning. Research and medicine is moving away from behavioural responses to assess brain health (e.g. verbal responses, reaction time, etc.) and are moving toward more neuroimaging focused measures, such as CT, and MRI scans. The strength of utilizing EEG technology is two-fold: i) it is portable and ii) has high temporal resolution. Looking forward, EEG-based brain assessment technology could be implemented field-side, at the site of an accident for a quick assessment of brain and cognitive functioning, or within a clinicians' office to evaluate treatment efficacy. However, for this type of technology to be useful in quantifying brain health, we must first quantify the degree to which a healthy brain naturally fluctuates in it processing capability. For example, should technology such as the NeuroCatch Platform™ be used as a monitoring tool, we must have an idea of what normal variation is.
|Condition or disease||Intervention/treatment||Phase|
|Brain Health||Device: NeuroCatch Platform™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will be asked to attend 4 separate experimental sessions over the course of approximately 4 weeks (i.e. one session/week). During each session, participants will listen to three different auditory stimulus sequences including sounds and words while EEG activity is recorded. There will be 5-minute break between each audio sequence. Each experimental session will take approximately 30-45 minutes to complete.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Assessing Repeatability of NeuroCatch Platform™ Measurements: An Initial Assessment|
|Actual Study Start Date :||January 2, 2018|
|Actual Primary Completion Date :||February 1, 2018|
|Actual Study Completion Date :||February 1, 2018|
Experimental: Intervention Arm
All participants will be asked to attend 4 separate experimental sessions over the course of approximately 4 weeks (i.e. one session/week). During each session, participants will listen to three different auditory stimulus sequences including sounds and words while EEG activity is recorded using the NeuroCatch Platform™ device.
Device: NeuroCatch Platform™
NeuroCatch Platform™ consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP) information.
- Variability of response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform™ during the baseline visit [ Time Frame: 1 day ]Response size will be measured as amplitude in microvolts.
- Variability of response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform™ during the baseline visit [ Time Frame: 1 day ]Response timing will be measured as latency in milliseconds.
- Qualitative comparison of ERP graphs generated by different auditory stimulus sequences during the NeuroCatch Platform™ assessment [ Time Frame: 1 day ]ERP graphs will be overlaid. Trained technician will assess if peaks and valleys occur at expected time points for different sequences.
- Collection and evaluation of adverse events and adverse device effects [ Time Frame: 4 weeks ]Evaluation of safety and tolerability of the NeuroCatch Platform™ device
- Slope of change over time in response size to quantify the natural variability in selected ERPs (N100, P300, N400) acquired using NeuroCatch Platform™ [ Time Frame: 4 weeks ]Response size will be measured as amplitude in microvolts. Means will be calculated and compared over time.
- Slope of change over time in response timing to quantify the natural variability in selected ERPs (N100, P300, N400) acquired using NeuroCatch Platform™ [ Time Frame: 4 weeks ]Response timing will be measured as latency in milliseconds. Means will be calculated and compared over time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421405
|Canada, British Columbia|
|HealthTech Connex Inc. Centre for Neurology Studies|
|Vancouver, British Columbia, Canada, V3V 0C6|
|Principal Investigator:||Jan Venter, MBChB MFamMed CCFP IFMCP||HealthTech Connex Inc. Centre for Neurology Studies|