Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion

NCT03889483 | Unknown

• 1 other identifier: ACH-NCI-001
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of adverse events and adverse device effects

  1 day

• Collection of ERP response size (amplitude in microvolts) and response timing (latency in milliseconds)

  1 day

Other Outcomes (1)

• Explore trends between select additional measures of impairment and ERPs across four pediatric cohorts.

  1 day

Study Arms (1)

NeuroCatch™ Platform Assessment

OTHER

All participants will undergo two NeuroCatch™ Platform Assessments.

Device: NeuroCatch™ Platform

Interventions

NeuroCatch™ Platform DEVICE

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.

NeuroCatch™ Platform Assessment

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male, female, or intersex
• years old inclusively
• Must meet all criteria in one of the following cohorts:
• Cohort 1: Has persistent mTBI symptoms 6-16 weeks post-injury, as determined by the Investigator;
• Cohort 2: Recovered quickly (within approximately six weeks) from mTBI, as determined by the Investigator 6-16 weeks post-injury;
• 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;
• Cohort 4: Has never had a concussion.

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Michael Esser: lead
• NeuroCatch Inc.: collaborator

Study Sites (1)

Alberta Children's Hospital, Department of Paediatrics

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michael Esser

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Esser, MD

CONTACT

(403) 955 -7911; Michael.Esser@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 26, 2019
• Study Start: November 30, 2018
• Primary Completion: September 30, 2021
• Study Completion: December 30, 2021
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

CA (1)