Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion
Primary Purpose
Children, Only, Traumatic Brain Injury, Concussion, Mild
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
NeuroCatch™ Platform
Sponsored by
About this trial
This is an interventional other trial for Children, Only
Eligibility Criteria
Inclusion Criteria:
- Male, female, or intersex
- 8-18 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.
Exclusion Criteria:
- 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
Sites / Locations
- Alberta Children's Hospital, Department of PaediatricsRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
NeuroCatch™ Platform Assessment
Arm Description
All participants will undergo two NeuroCatch™ Platform Assessments.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Number of adverse events and adverse device effects
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)
Quantifying the natural variability in selected ERPs (N100, P300, N400) acquired using the NeuroCatchTM Platform in one study session.
Full Information
NCT ID
NCT03889483
First Posted
March 22, 2019
Last Updated
January 12, 2021
Sponsor
Dr. Michael Esser
Collaborators
NeuroCatch Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03889483
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Michael Esser
Collaborators
NeuroCatch Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Only, Traumatic Brain Injury, Concussion, Mild, Pediatric ALL
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NeuroCatch™ Platform Assessment
Arm Type
Other
Arm Description
All participants will undergo two NeuroCatch™ Platform Assessments.
Intervention Type
Device
Intervention Name(s)
NeuroCatch™ Platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tracking and comparison of neurophysiological changes (ERP response size) to persistence of mTBI symptoms
Description
Response size will be measured as amplitude in microvolts. Persistence of mTBI symptoms will be defined by cohort.
Time Frame
1 day
Title
Tracking and comparison of neurophysiological changes (ERP response timing) to persistence of mTBI symptoms
Description
Response timing will be measured as latency in milliseconds. Persistence of mTBI symptoms will be defined by cohort.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number of adverse events and adverse device effects
Description
Assessing the safety and performance of the NeuroCatchTM Platform in four pediatric cohorts.
Time Frame
1 day
Title
Collection of ERP response size (amplitude in microvolts) and response timing (latency in milliseconds)
Description
Quantifying the natural variability in selected ERPs (N100, P300, N400) acquired using the NeuroCatchTM Platform in one study session.
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
Explore trends between select additional measures of impairment and ERPs across four pediatric cohorts.
Description
Additional measures of impairment may include cognitive assessments, blood work and DNA analysis, brain imaging (MRI) and levels of carbon dioxide in the breath.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male, female, or intersex
8-18 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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Esser, MD
Phone
(403) 955 -7911
Email
Michael.Esser@albertahealthservices.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Esser
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital, Department of Paediatrics
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Esser, MD
Phone
(403) 955-7911
Email
Michael.Esser@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Michael Esser, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion
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