Assessing the Impact of the NeuroCatch Platform 2 Stimulus Tone Volume

NCT04956172 | Completed

• 1 other identifier: NCI_NCClin_005
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The NeuroCatch Platform 2 (NCP2), an investigational medical device system developed by NeuroCatch Inc., 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; brain response to a stimulus) information. The NCP2 uses two types of tones to elicit N100 and P300 ERPs, along with two types of words to elicit N400 ERPs. The objective of this study is to determine if changing the volume of the standard tone has an effect on the amplitudes and latencies of the ERPs.

Conditions

Brain Health

Outcome Measures

Primary Outcomes (6)

• Difference in amplitude of the N100 ERP

  Amplitude (response size) will be measured in microvolts. The statistic being used to measure the difference in amplitude between the two Tone types will be a full-factorial repeated measures analysis of variance (Factors: Tone type, Session number, Run number)

  1 week (6-8 days)

• Difference in latency of the N100 ERP

  Latency (response time) will be measured in microseconds. The statistic being used to measure the difference in amplitude between the two Tone types will be a full-factorial repeated measures analysis of variance (Factors: Tone type, Session number, Run number)

  1 week (6-8 days)

• Difference in amplitude of the P300 ERP

  Amplitude (response size) will be measured in microvolts. The statistic being used to measure the difference in amplitude between the two Tone types will be a full-factorial repeated measures analysis of variance (Factors: Tone type, Session number, Run number)

  1 week (6-8 days)

• Difference in latency of the P300 ERP

  Latency (response time) will be measured in microseconds. The statistic being used to measure the difference in amplitude between the two Tone types will be a full-factorial repeated measures analysis of variance (Factors: Tone type, Session number, Run number)

  1 week (6-8 days)

• Difference in amplitude of the N400 ERP

  Amplitude (response size) will be measured in microvolts. The statistic being used to measure the difference in amplitude between the two Tone types will be a full-factorial repeated measures analysis of variance (Factors: Tone type, Session number, Run number)

  1 week (6-8 days)

• Difference in latency of the N400 ERP

  Latency (response time) will be measured in microseconds. The statistic being used to measure the difference in amplitude between the two Tone types will be a full-factorial repeated measures analysis of variance (Factors: Tone type, Session number, Run number)

  1 week (6-8 days)

Secondary Outcomes (13)

• Repeatability of the N100 Amplitude for Tone A

  1 week (6-8 days)

• Repeatability of the N100 Amplitude for Tone B

  1 week (6-8 days)

• Repeatability of the N100 Latency for Tone A

  1 week (6-8 days)

• Repeatability of the N100 Latency for Tone B

  1 week (6-8 days)

• Repeatability of the P300 Amplitude for Tone A

  1 week (6-8 days)

Study Arms (2)

Tone A

ACTIVE COMPARATOR

Tone A uses an 80dB standard tone

Device: NeuroCatch Platform 2

Tone B

EXPERIMENTAL

Tone B uses a 93dB standard tone

Device: NeuroCatch Platform 2

Interventions

NeuroCatch Platform 2 DEVICE

To elicit the ERP components of interest in this study (N100, P300, N400), proprietary auditory stimulus sequences will be administered using the NeuroCatch Platform 2, an investigational medical device. Each sequence consists of tones and word pairs to elicit the various components of interest. The NeuroCatch Platform 2 consists of a computerized acquisition software which presents the stimulus, acquires the data and presents the amplitude and latency values of the ERP components (N100, N400, P300)

Tone A; Tone B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any sex, at least 19 years of age or older
• Able to understand the informed consent form, study procedures and willing to participate in study
• Able to remain seated and focused for 7 minutes
• In good health with no history of clinically relevant neurological illness or injury in the last 5 years

You may not qualify if:

• 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).
• Implanted pacemaker or implanted electrical stimulators
• Metal or plastic implants in the skull, excluding dental/facial implants.
• Exposed to an investigational drug or device 30 days prior to start in this study, or concurrent or planned use of investigational drug or device while enrolled in this study
• Not proficient in English language
• Diagnosed epilepsy or history of seizures
• If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
• Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)
• Allergy to EEG gel or history of contact dermatitis

Sponsors & Collaborators

• NeuroCatch Inc.: lead

Study Sites (1)

HealthTech Connex Centre for Neurology Studies

Surrey, British Columbia, V3V 0C6, Canada

Location

Study Officials

• Bimal Lakhani, PhD

  NeuroCatch Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not informed the order or type (standard Tone A, standard Tone B) of the sequences
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a within-subject repeated-measures, randomly counterbalanced, single blind study. All participants will be asked to attend two study visits, one week (6-8 days) apart. At each study visit, participants will complete two NeuroCatch Platform 2 assessments with different auditory sequences. One sequence will include the Standard Tone A (80dB), and another will include Standard Tone B (93dB) while keeping the deviant tone volume consistent (105dB). The order of presentation of the two sequences will be randomly counterbalanced (i.e Session 1: AB \& Session 2: BA, or Session 1: BA \& Session 2: AB).

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 9, 2021
• Study Start: July 12, 2021
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

CA (1)