Children, OnlyNCT03889483
Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion
A study testing NeuroCatch™ Platform in people with Children, Only and Traumatic Brain Injury, run by Dr. Michael Esser at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Only, Traumatic Brain Injury, Concussion, Mild
- What is being tested?
- NeuroCatch™ Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2018to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Alberta Children's Hospital, Department of Paediatrics
Calgary, Alberta, T3B 6A8
Michael Esser, MD, (403) 955-7911, Michael.Esser@albertahealthservices.ca
Michael Esser, MD
About this study
Official title: Neurophysiological Measurements in the Pediatric Concussion Population: An Initial Assessment Using the NeuroCatch™ Platform
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.
- Being tested
- NeuroCatch™ Platform
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroCatch™ PlatformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NeuroCatch™ Platform Assessment | Other | All participants will undergo two NeuroCatch™ Platform Assessments. Receives: Device: NeuroCatch™ Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
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.
Measured: 1 day
Secondary outcomes (2)
Number of adverse events and adverse device effects
Assessing the safety and performance of the NeuroCatchTM Platform in four pediatric cohorts.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start30 Nov 2018
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Michael Esser
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroCatch Inc.
- Responsible party
- Sponsor-investigator, Dr. Michael Esser, Alberta Children's Hospital
- Investigators
- Michael Esser, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889483
- Sponsor's protocol ID
- ACH-NCI-001
- Status last verified
- Jan 2021
- First submitted
- 22 Mar 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Measurements in the Pediatric Concussion Population: An Initial Assessment Using the NeuroCatch™ Platform
- ClinicalTrials.gov ID
- NCT03889483
- Acronym / sponsor ID
- ACH-NCI-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Dr. Michael EsserUniversity, hospital or other
- Collaborators
- NeuroCatch Inc.
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| NeuroCatch™ Platform Assessment | Other | Device: NeuroCatch™ PlatformAll participants will undergo two NeuroCatch™ Platform Assessments. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Male, female, or intersex
- 8-18 years old inclusively
- Must meet all criteria in one of the following cohorts:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroCatch™ PlatformThe 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. | Device | NeuroCatch™ Platform Assessment |
Primary outcome
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.
2 secondary outcomes
Number of adverse events and adverse device effects
Time frame: 1 day
Collection of ERP response size (amplitude in microvolts) and response timing (latency in milliseconds)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Esser principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroCatch™ Platform in people with Children, Only and Traumatic Brain Injury, run by Dr. Michael Esser at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Esser, MD ((403) 955 -7911, Michael.Esser@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracking and comparison of neurophysiological changes (ERP response size) to persistence of mTBI symptoms (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021; AzTrials last refreshed its copy on 26 Oct 2026.