Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion
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|ClinicalTrials.gov Identifier: NCT03889483|
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : March 27, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Children, Only Traumatic Brain Injury Concussion, Mild Pediatric ALL||Device: NeuroCatch™ Platform||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|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)|
|Official Title:||Neurophysiological Measurements in the Pediatric Concussion Population: An Initial Assessment Using the NeuroCatch™ Platform|
|Actual Study Start Date :||November 30, 2018|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2020|
NeuroCatch™ Platform Assessment
All participants will undergo two NeuroCatch™ Platform Assessments.
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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889483
|Contact: Michael Esser, MD||(403) 955 -7911||Michael.Esser@albertahealthservices.ca|
|Alberta Children's Hospital, Department of Paediatrics||Recruiting|
|Calgary, Alberta, Canada, T3B 6A8|
|Contact: Michael Esser, MD (403) 955-7911 Michael.Esser@albertahealthservices.ca|
|Principal Investigator: Michael Esser, MD|
|Principal Investigator:||Michael Esser||University of Calgary|