Clinical trial NCT03421405: Assessing Repeatability of NeuroCatch Platform™ Measurements: An Initial Assessment
Official title: Assessing Repeatability of NeuroCatch Platform™ Measurements: An Initial Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Health
Lead sponsor: NeuroCatch Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 19-65 years old inclusively
2. Normal hearing capabilities
3. Able to understand the informed consent form, study procedures and willing to participate in study
4. Able to keep eyes still for min 6 minutes

Exclusion Criteria:

1. Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems, punctured ear drum, etc.)
2. Implanted pacemaker
3. Metal or plastic implants in skull
4. In-ear hearing aid or chocclear implant, hearing device
5. Chronic neurological disorder (e.g. Stroke, MS, etc.)
6. Recent (within last 6 months) acquired brain injury
7. History of brain cancer
8. History of dementia
9. Exposed to investigational drug or device 30 days prior to start in this study, or concurrent use of investigational drug or device while enrolled in this study
10. Planning to use investigational drugs or devices while enrolled in this study
11. Not fluent in English language
12. Unable to provide informed consent
13. Previous participation in studies using the NeuroCatch Platform™
14. If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
15. History of seizures
16. Allergy to rubbing alcohol or EEG gel

Primary outcomes:
measure: Variability of response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform™ during the baseline visit
timeFrame: 1 day
measure: Variability of response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform™ during the baseline visit
timeFrame: 1 day
Secondary outcomes:
measure: Qualitative comparison of ERP graphs generated by different auditory stimulus sequences during the NeuroCatch Platform™ assessment
timeFrame: 1 day
measure: Collection and evaluation of adverse events and adverse device effects
timeFrame: 4 weeks
measure: Slope of change over time in response size to quantify the natural variability in selected ERPs (N100, P300, N400) acquired using NeuroCatch Platform™
timeFrame: 4 weeks
measure: Slope of change over time in response timing to quantify the natural variability in selected ERPs (N100, P300, N400) acquired using NeuroCatch Platform™
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: HealthTech Connex Inc. Centre for Neurology Studies
state: British Columbia
Study officials:
affiliation: HealthTech Connex Inc. Centre for Neurology Studies
name: Jan Venter, MBChB MFamMed CCFP IFMCP
role: PRINCIPAL_INVESTIGATOR
References: