Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion

Neurophysiological Measurements in the Pediatric Concussion Population: An Initial Assessment Using the NeuroCatch™ Platform

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. The current research is primarily focused on three ERP components: the N100, P300 and N400. Each of the three ERPs have been studied in the academic laboratory for multiple decades. Through this research, a strong understanding has been developed regarding what can affect these components (e.g. task set, emotional state, etc.). However, these signals within various pediatric populations (e.g., those with persistent mTBI symptoms or multiple concussions) are not well characterized.

Being able to safely and effectively employ the NeuroCatch™ Platform in a post-concussive pediatric cohort could provide researchers with the potential to elucidate the persistence of objective measures of impairment, patterns of recovery, and chronicity of problems due to mTBI in children. Secondly, understanding the degree to which these neurophysiological components fluctuate over time is crucial to the understanding of brain functioning. However, for this type of technology to be useful in quantifying brain health in this population,the degree to which a post-concussive pediatric brain naturally fluctuates in its processing capability must be quantified. NeuroCatch™ Platform has the ability to measure changes in several domains of brain function. These cognitive processes are foundational blocks for some of the highest cognitive processes: information integration and executive functioning.

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Injury; Pediatric ALL; Children, Only; Concussion, Mild
• Intervention / Treatment: Device: NeuroCatch™ Platform

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Esser, MD; Phone Number: (403) 955 -7911; Email: Michael.Esser@albertahealthservices.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Recruiting
      • Alberta Children's Hospital, Department of Paediatrics
      • Contact: Michael Esser, MD; Phone Number: (403) 955-7911; Email: Michael.Esser@albertahealthservices.ca
      • Principal Investigator: Michael Esser, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male, female, or intersex
2. 8-18 years old inclusively

3. Must meet all criteria in one of the following cohorts:

   1. Cohort 1: Has persistent mTBI symptoms 6-16 weeks post-injury, as determined by the Investigator;
   2. Cohort 2: Recovered quickly (within approximately six weeks) from mTBI, as determined by the Investigator 6-16 weeks post-injury;
   3. Cohort 3: Has had multiple mTBIs (2 or more medically verified concussions over the last year) with the most recent injury having occurred 6-16 weeks prior to study enrollment;
   4. Cohort 4: Has never had a concussion.

Exclusion Criteria:

1. Previous neurological illnesses (e.g., epilepsy or seizure disorders) including moderate to severe learning difficulties, as determined by the Investigator
2. Clinically documented hearing issues (e.g., tinnitus, in-ear hearing problems, punctured ear drum)
3. In-ear hearing aid or cochlear implant, hearing devices
4. Implanted pacemaker
5. Metal or plastic implants in skull
6. Allergy to rubbing alcohol or EEG gel
7. Previous participation in one or more studies using the NeuroCatchTM Platform
8. Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)
9. Using other investigational drugs or devices while enrolled in this study
10. Not fluent in the English language
11. If female and of child-bearing potential: suspected or planning to become pregnant, currently pregnant, or breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NeuroCatch™ Platform Assessment; All participants will undergo two NeuroCatch™ Platform Assessments.	Device: NeuroCatch™ Platform; The NeuroCatch™ Platform 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) information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracking and comparison of neurophysiological changes (ERP response size) to persistence of mTBI symptoms	Response size will be measured as amplitude in microvolts. Persistence of mTBI symptoms will be defined by cohort.	1 day
Tracking and comparison of neurophysiological changes (ERP response timing) to persistence of mTBI symptoms	Response timing will be measured as latency in milliseconds. Persistence of mTBI symptoms will be defined by cohort.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events and adverse device effects	Assessing the safety and performance of the NeuroCatchTM Platform in four pediatric cohorts.	1 day
Collection of ERP response size (amplitude in microvolts) and response timing (latency in milliseconds)	Quantifying the natural variability in selected ERPs (N100, P300, N400) acquired using the NeuroCatchTM Platform in one study session.	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explore trends between select additional measures of impairment and ERPs across four pediatric cohorts.	Additional measures of impairment may include cognitive assessments, blood work and DNA analysis, brain imaging (MRI) and levels of carbon dioxide in the breath.	1 day

Collaborators and Investigators

• Sponsor: Dr. Michael Esser
• Collaborators: NeuroCatch Inc.
• Investigators: Principal Investigator: Michael Esser, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: ACH-NCI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No