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Trial record 1 of 1 for:    NCT03889483
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Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion

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ClinicalTrials.gov Identifier: NCT03889483
Recruitment Status : Unknown
Verified January 2021 by Dr. Michael Esser, Alberta Children's Hospital.
Recruitment status was:  Recruiting
First Posted : March 26, 2019
Last Update Posted : January 13, 2021
NeuroCatch Inc.
Information provided by (Responsible Party):
Dr. Michael Esser, Alberta Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Children, Only Traumatic Brain Injury Concussion, Mild Pediatric ALL Device: NeuroCatch™ Platform Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: N/A
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)
Primary Purpose: Other
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 : September 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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

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Contact: Michael Esser, MD (403) 955 -7911 Michael.Esser@albertahealthservices.ca

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Canada, Alberta
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         
Sponsors and Collaborators
Dr. Michael Esser
NeuroCatch Inc.
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Principal Investigator: Michael Esser University of Calgary
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Responsible Party: Dr. Michael Esser, Principal Investigator, Alberta Children's Hospital
ClinicalTrials.gov Identifier: NCT03889483    
Other Study ID Numbers: ACH-NCI-001
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating