NeuroCatch Reference Interval Database
- Conditions
- Healthy ControlsBrain Function
- Registration Number
- NCT06677424
- Lead Sponsor
- HealthTech Connex Inc.
- Brief Summary
The purpose of this study is to understand how the brain responds to sounds and words, and how this response varies between individuals. The purpose if this study is to develop data set comparing the results from one individual with those from other members (a reference interval database of NeuroCatch® Platform 2) and to quantify the expected distribution across sex and age. NeuroCatch® Platform 2, is a medical device approved by Health Canada. The plan is to enroll 810 participants, the study includes screening for eligibility and one brain scan. The study is conducted at the Centre for Neurology Studies in Surrey, BC or at its satellite sites ( if required).
- Detailed Description
Study specific Procedures: Includes a screen for eligibility and a scan visit. The total time 30 minutes to 1 hour for the whole study. The procedures can be completed on the same day or split between two days.
Screening visit (15- 30min, virtual visit): Prior to any procedures being conducted, Informed Consent Form will be reviewed in detail, an opportunity will be given to decide to participate in the study or not and if all the study requirements are met as well as all the questions have been answered, consent form is signed. Participant study eligibility is reviewed including medical history, and brain scan requirements. If participant is eligible, scan visit will be completed. If participant is not eligible no further study procedures will be completed.
Scan visit (15-30 min at the clinic): During the scan visit demographic information ( date of birth, sex, level of education, recent sleep, self-described mood, caffeine intake, alcohol consumption, nicotine usage, psychoactive usage, handedness, first language, profession and current medications) is collected, brain scan safety questionnaire is completed and a brain scan with NeuroCatch® Platform 2 will be completed.
NeuroCatch scan procedure: A cap with the EEG sensors is placed on your scalp and will be adjusted to get good recordings of brain activity. An alcohol pad is used to clean the skin of your forehead, and a plastic syringe tip or wooden dowel to move your hair out of the way to place the EEG sensors/electrodes. A small amount of a conductive gel is applied under each electrode. This takes between 5-20 minutes. Once its all set up, you will be asked to listen to an auditory sequence that is 6 minutes long. During this period, you are asked to sit still and listen to the sounds and the words.
Any information about you obtained from or for this research study will be kept as confidential as possible, All participants will be assigned a participant ID and data will identified using the ID.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 810
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Amplitude & Latency collection for NeuroCatch® Platform 2 20 minutes Response size (amplitude in microvolts) and response timing (latency in milliseconds) will be collected for the ERPs N100, P300 and N400.
Demographic indicators 5 minutes Demographic indicators to be collected such as year of birth, sex, level of education.
- Secondary Outcome Measures
Name Time Method Assessing Influences on Brain Function: NeuroCatch® to Lifestyle and Health Factors 5 minutes Measurements include: current medications, mood, total sleep hours, caffeine and alcohol intake, nicotine and psychoactive substance use, as well as any medications taken within 24 hours before the scan, noting whether each is more, less, or equal to the participant's typical amount.
Trial Locations
- Locations (1)
Centre for Neurology Studies, 13761 96 Ave, Unit 1004
🇨🇦Surrey, British Columbia, Canada