Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion

• ClinicalTrials.gov Identifier: NCT03889483
• Recruitment Status: Recruiting
• First Posted: March 26, 2019
• Last Update Posted: January 13, 2021
• Sponsor: Dr. Michael Esser
• Collaborator: NeuroCatch Inc.
• Information provided by (Responsible Party): Dr. Michael Esser, Alberta Children's Hospital

Tracking Information

• First Submitted Date: March 22, 2019
• First Posted Date: March 26, 2019
• Last Update Posted Date: January 13, 2021
• Actual Study Start Date: November 30, 2018
• Estimated Primary Completion Date: September 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 22, 2019)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 25, 2019)

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

Original Secondary Outcome Measures (submitted: March 22, 2019)

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

Current Other Pre-specified Outcome Measures (submitted: March 22, 2019)

Explore trends between select additional measures of impairment and ERPs across four pediatric cohorts. [ Time Frame: 1 day ]

Additional measures of impairment may include cognitive assessments, blood work and DNA analysis, brain imaging (MRI) and levels of carbon dioxide in the breath.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion
• Official Title: Neurophysiological Measurements in the Pediatric Concussion Population: An Initial Assessment Using the NeuroCatch™ Platform

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Participants will be divided into the following cohorts:

Cohort 1: 30 participants with persistent mTBI symptoms (duration greater than 6 weeks), as determined by the Investigator; Cohort 2: 30 participants who recovered quickly from mTBI (i.e., within approximately six weeks based on symptomatology), as determined by the Investigator; Cohort 3: 15 participants who have had multiple mTBIs (2 or more medically verified concussions over the last year); and Cohort 4: 30 participants who have never had a concussion. Participants in Cohorts 1-3 will be recruited 6-16 weeks post injury date.

After study enrollment, all participants undergo two NeuroCatch Platform assessments.

Masking: None (Open Label)
Primary Purpose: Other

Condition

• Children, Only
• Traumatic Brain Injury
• Concussion, Mild
• Pediatric ALL

Intervention

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.

Study Arms

NeuroCatch™ Platform Assessment

All participants will undergo two NeuroCatch™ Platform Assessments.

Intervention: Device: NeuroCatch™ Platform

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 22, 2019): 105
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2021
• Estimated Primary Completion Date: September 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Michael Esser, MD; (403) 955 -7911; Michael.Esser@albertahealthservices.ca

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03889483
• Other Study ID Numbers: ACH-NCI-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Dr. Michael Esser, Alberta Children's Hospital
• Study Sponsor: Dr. Michael Esser
• Collaborators: NeuroCatch Inc.

Investigators

• Principal Investigator: Michael Esser; University of Calgary

• PRS Account: Alberta Children's Hospital
• Verification Date: January 2021