Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion

NCT ID: NCT03889483

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2021-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

NeuroCatch™ Platform Assessment

All participants will undergo two NeuroCatch™ Platform Assessments.

Group Type: OTHER

NeuroCatch™ Platform

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NeuroCatch Inc.

INDUSTRY

Sponsor Role: collaborator

Dr. Michael Esser

OTHER

Sponsor Role: lead

Responsible Party

Dr. Michael Esser

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Esser

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Alberta Children's Hospital, Department of Paediatrics

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Michael Esser, MD

Role: CONTACT

Michael.Esser@albertahealthservices.ca

(403) 955 -7911

Facility Contacts

Michael Esser, MD

Role: primary

Michael.Esser@albertahealthservices.ca

(403) 955-7911

Other Identifiers

ACH-NCI-001

Identifier Type: -

Identifier Source: org_study_id