Actively Recruiting
Empirical Distributions of ERP Components Elicited by the NeuroCatch4 Platform 2: Development of a Reference Interval Database
Led by HealthTech Connex Inc. · Updated on 2024-11-06
810
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
H
HealthTech Connex Inc.
Lead Sponsor
N
NeuroCatch Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how the brain responds to sounds and words and how this response varies among individuals. The goal is to develop a reference interval database using the NeuroCatch4 Platform 2, a Health Canada-approved medical device, to compare individual brain scan results across different ages and sexes. The study plans to enroll 810 participants and includes screening for eligibility and one brain scan visit. Participants undergo a screening visit, which can be virtual and lasts 15 to 30 minutes, to review consent, medical history, and eligibility. If eligible, they attend a scan visit lasting 15 to 30 minutes where demographic information is collected, and a brain scan is performed using the NeuroCatch4 Platform 2 device. During the scan, EEG sensors are placed on the scalp, and participants listen to a 6-minute audio sequence of tones and words designed to safely elicit brain responses. Participants will provide information about age, sex, education, mood, recent sleep, and lifestyle factors during the scan visit. The NeuroCatch4 software records and processes EEG data to generate brain response results. The study measures brain response amplitude and latency and explores how lifestyle and health factors influence brain function. All data are kept confidential, and the total participation time ranges from 30 minutes to one hour, with procedures completed either on the same day or split over two days.
CONDITIONS
Brief Title
NeuroCatch Reference Interval Database
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any sex, age 6 years or older
- Able to understand informed consent/assent form in English and willing to participate
- Participants under 19 must have a parent/guardian able to provide consent
- Able to remain seated and focused for 7 minutes
- In good health with no history of clinically relevant neurological illness or injury
You will not qualify if you...
- Use of hearing aids or cochlear implant, active tinnitus, or temporary hearing damage
- Unable to detect a 740Hz tone at 85dB in both ears
- Implanted pacemaker or other electrical stimulator
- Metal or plastic implants in the skull (excluding dental/facial implants)
- Not native-level English speaker
- Previous exposure to NeuroCatch4 Platform 2 audio sequences in last 3 months
- History of neurological disorders or injury (e.g., epilepsy, Parkinson's, brain injury)
- History of chronic pain or headache disorders (e.g., migraine, fibromyalgia)
- Diagnosed sleeping disorders
- Diagnosed memory disorders
- History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder)
- History of alcohol or substance misuse impacting brain function
- Use of medications affecting brain function (e.g., antiepileptics, antipsychotics)
- Serious medical conditions affecting brain function (e.g., stroke, brain tumor)
- Undergoing chemotherapy or intensive long-term therapy impacting brain function
- Unhealthy scalp (open wounds, bruised or weakened skin)
- Allergy to EEG gel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 virtual visit
Duration - Same day or within 2 days after screening
Participants undergo a brain scan using the NeuroCatch® Platform 2 device. This includes placing an EEG sensor cap, applying conductive gel, and listening to a 6-minute auditory stimulus sequence while brain activity is recorded.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Centre for Neurology Studies, 13761 96 Ave, Unit 1004
Surrey, British Columbia, Canada, V3V 0E8
Actively Recruiting
Research Team
S
Sonia Brodie
M
Monica Vo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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