Clinical trial NCT03889483: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Children, Only
Traumatic Brain Injury
Concussion, Mild
Pediatric ALL
Lead sponsor: Alberta Children's Hospital
Sponsor class: OTHER
Collaborators: name: NeuroCatch Inc.
First posted: 2019-03-26
Enrollment: 105
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Tracking and comparison of neurophysiological changes (ERP response size) to persistence of mTBI symptoms
timeFrame: 1 day
measure: Tracking and comparison of neurophysiological changes (ERP response timing) to persistence of mTBI symptoms
timeFrame: 1 day
Secondary outcomes:
measure: Number of adverse events and adverse device effects
timeFrame: 1 day
measure: Collection of ERP response size (amplitude in microvolts) and response timing (latency in milliseconds)
timeFrame: 1 day
Other outcomes:
measure: Explore trends between select additional measures of impairment and ERPs across four pediatric cohorts.
timeFrame: 1 day
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital, Department of Paediatrics
state: Alberta
Study officials:
affiliation: University of Calgary
name: Michael Esser
role: PRINCIPAL_INVESTIGATOR
References: