Clinical trial NCT06677424: NeuroCatch Reference Interval Database
Official title: Empirical Distributions of ERP Components Elicited by the NeuroCatch® Platform 2: Development of a Reference Interval Database
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Controls
Brain Function
Keywords: Brain Scan, NeuroCatch®
Lead sponsor: HealthTech Connex Inc.
Sponsor class: INDUSTRY
Collaborators: name: NeuroCatch Inc.
First posted: 2024-11-06
Enrollment: 810
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, non-randomized, between-subject design
Primary purpose: OTHER

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.

Eligibility criteria: INCLUSION CRITERIA

1. Any sex, at least 6 years of age or older
2. Able to understand the informed consent/assent form (in English), study procedures and willing to participate in study; participants under 19 must also have a parent/guardian who is able to understand and provide informed consent on their behalf.
3. Able to remain seated and focused for 7 minutes
4. In good health with no history of clinically relevant neurological illness or injury

EXCLUSION CRITERIA

1. Requires the use of hearing aids or a cochlear implant, diagnosed with tinnitus that is currently active, or has temporary damage to hearing (e.g., punctured ear drum). Or unable to detect a 740Hz tone played at 85dB in both ears.
2. Implanted pacemaker or other electrical stimulator(s)
3. Metal or plastic implants in the skull, excluding dental/facial implants.
4. Not native-level in English
5. Previous exposure to the NeuroCatch® Platform 2 audio sequences in the last 3 months
6. History of clinically relevant neurological disorders or injury (e.g., epilepsy, Parkinson's disease, traumatic brain injury, etc.)
7. History of chronic pain or chronic headache disorders (e.g. migraine, tension headaches, fibromyalgia, etc.)
8. Currently diagnosed with any sleeping disorders (e.g. sleep apnea, hypersomnia, insomnia, parasomnia, etc.)
9. Diagnosed with any memory disorders.
10. History of clinically relevant major psychiatric disorders (e.g., schizophrenia, bipolar disorder, etc.)
11. History of alcohol or substance misuse that, in the opinion of the Investigator, may impact brain function
12. Use of medications that affect brain function (e.g., antiepileptic drugs, antipsychotics, stimulants, etc.)
13. Serious medical conditions affecting brain functions (e.g., stroke, brain tumor, neurodegenerative diseases, etc.)
14. Undergoing chemotherapy or any form of intensive long-term therapy that, in the opinion of the Investigator, may impact brain function.
15. Unhealthy scalp (e.g., apparent open wounds and/or bruised or weakened skin)
16. Allergy to EEG gel

Primary outcomes:
measure: Amplitude & Latency collection for NeuroCatch® Platform 2
timeFrame: 20 minutes
measure: Demographic indicators
timeFrame: 5 minutes
Secondary outcomes:
measure: Assessing Influences on Brain Function: NeuroCatch® to Lifestyle and Health Factors
timeFrame: 5 minutes
Other outcomes:
measure: Safety assessments
timeFrame: 30 minutes
Locations:
city: Surrey
country: Canada
facility: Centre for Neurology Studies, 13761 96 Ave, Unit 1004
state: British Columbia
Study officials:
affiliation: Centre for Neurology Studies
name: Jan Venter, MD
role: PRINCIPAL_INVESTIGATOR
References: