Brain ConcussionNCT05287997
Blood Biomarker Study to Diagnose Adolescent Sport Concussion
A study testing Neurolytixs Index in people with Brain Concussion, run by Neurolytixs at 2 sites in 2 countries.
Trial summary
Concussions are one of the most complex conditions to manage in sport medicine due to the individualized clinical presentation, caused by a complex neurometabolic cascade, and the lack of a diagnostic standard. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion
- What is being tested?
- Neurolytixs Index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2022to Dec 2023
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Provision of signed and dated informed consent/assent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female athletes, aged 13-17 inclusive
Who cannot join
- Individuals who have suffered a known concussion within the 6 months prior to enrollment
- Individuals who suffer from an acute neurological disorder
- Known pregnancy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Legacy Center Sports Complex
Brighton, Michigan, 48116
Cori Crocker
Canada1 site, 1 recruiting
- Recruiting
The Hill Academy
Caledon, Ontario, L7K 1S7
Jennifer Bell
About this study
Official title: A 2-Part Capillary Blood Biomarker Cohort Study to Diagnose Adolescent Sport Concussion
Concussions are one of the most complex conditions to manage in sport medicine due to the individualized clinical presentation, caused by a complex neurometabolic cascade, and the lack of a diagnostic standard. There is currently no objective measurement for concussion and the reliance on subjective reporting and clinical judgement is imperfect.
In previous clinical studies the investigators determined cutoff values of plasma phosphatidylcholines that provided strong indication that a concussion had occurred. Based on this data, the investigators have developed a custom assay, which will work together with a capillary blood collection device. The current clinical trial will be conducted in two parts. Part A will allow the investigators to determine precise AUC cut-off values for the propriety, novel custom assay, and in Part B the investigators will assess the safety and efficacy of this device for concussion diagnosis in adolescent athletes aged 13-17.
- Conditions
- Brain Concussion
- Being tested
- Neurolytixs Index
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurolytixs IndexDiagnostic test
Capillary blood sample will be collected on a dried plasma sample (DPS) filter paper. The sample will be sent to a central laboratory where they will undergo metabolite extraction and analysis via mass spectrometry.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | Other | Participants in this arm will be evaluated at 3 time periods. Initial pre-season visit, mid-season visit and end-of-season visit. Capillary blood sample collection will occur at each visit. Receives: Diagnostic Test: Neurolytixs Index |
| Concussion | Experimental | Participants in this arm will transition from the baseline arm to the concussion arm if they experience a concussion during the course of the sporting season. They will be evaluated with 72 hours of the injury and then at 2-, 4-, and 12-weeks post-injury. Capillary blood sample collection will occur at each visit. Receives: Diagnostic Test: Neurolytixs Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Calculate population reference ranges for 10 phosphatidylcholines (PC) specific to Neurolytixs assay kit.
Population reference values will be determined with the standard definition of a reference range as the interval between which 95% of values of a reference population fall into, in such a way that 2.5% of the time a value will be less than the lower limit of this interval, and 2.5% of the time it will be larger than the upper limit of this interval, whatever the distribution of these values. Measured PC values will be plotted against both sex and the age of participants to which the PCs were measured.
Measured: End of Part A (4-6 months)
Part A: Generate Area Under the Curve (AUC) values specific to the Neurolytixs assay kit
Generate AUC values for 10 phosphatidylcholines (PCs) for use in Part B
Measured: End of Part A (4-6 months)
Part B: Determine efficacy of Neurolytixs assay kit for diagnosing adolescent sports concussion
The change of at least 1 PC below the cutoff threshold (determined in Part A)
Measured: 12-72 hours post-injury
Part B: Determine safety of the Neurolytixs assay kit for adolescent sports concussion
Calculate the number of false negatives (concussions that are not captured by the assay
Measured: Through study completion, up to 1 year
Part B: Determine safety of the Neurolytixs assay kit for adolescent sports concussion
Calculate the number of false positives identified by the assay
Measured: Through study completion, up to 1 year
Secondary outcomes (1)
Part B: Determine whether repeated plasma PC measurements over time correlate with injury symptom resolution or clinical recovery
Sensitivity and specificity of the assay compared to diagnosis via the SCAT5
Measured: 12 weeks post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Jun 2022
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will enrol into the Baseline Arm of the study. Participants will attend all Baseline Visits unless they experience a concussion at which point, they will transition to the Concussion Arm for further follow-up.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurolytixs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas D Fraser, MD/PhD, Principal investigator, Neurolytixs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287997
- Sponsor's protocol ID
- NLI01
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2022
- Last updated
- 4 Apr 2023
- 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 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part Capillary Blood Biomarker Cohort Study to Diagnose Adolescent Sport Concussion
- ClinicalTrials.gov ID
- NCT05287997
- Acronym / sponsor ID
- NLI01
- Conditions
- Brain Concussion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NeurolytixsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Mar 2022 (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.
Concussions are one of the most complex conditions to manage in sport medicine due to the individualized clinical presentation, caused by a complex neurometabolic cascade, and the lack of a diagnostic standard. There is currently no objective measurement for concussion and the reliance on subjective reporting and clinical judgement is imperfect.
In previous clinical studies the investigators determined cutoff values of plasma phosphatidylcholines that provided strong indication that a concussion had occurred. Based on this data, the investigators have developed a custom assay, which will work together with a capillary blood collection device. The current clinical trial will be conducted in two parts. Part A will allow the investigators to determine precise AUC cut-off values for the propriety, novel custom assay, and in Part B the investigators will assess the safety and efficacy of this device for concussion diagnosis in adolescent athletes aged 13-17.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will enrol into the Baseline Arm of the study. Participants will attend all Baseline Visits unless they experience a concussion at which point, they will transition to the Concussion Arm for further follow-up.
| Arm | Type | Receives |
|---|---|---|
| Baseline | Other | Diagnostic Test: Neurolytixs IndexParticipants in this arm will be evaluated at 3 time periods. Initial pre-season visit, mid-season visit and end-of-season visit. Capillary blood sample collection will occur at each visit. |
| Concussion | Experimental | Diagnostic Test: Neurolytixs IndexParticipants in this arm will transition from the baseline arm to the concussion arm if they experience a concussion during the course of the sporting season. They will be evaluated with 72 hours of the injury and then at 2-, 4-, and 12-weeks post-injury. Capillary blood sample collection will occur at each visit. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Provision of signed and dated informed consent/assent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female athletes, aged 13-17 inclusive
Key exclusion criteria (3 listed)
- Individuals who have suffered a known concussion within the 6 months prior to enrollment
- Individuals who suffer from an acute neurological disorder
- Known pregnancy
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 |
|---|---|---|
| Neurolytixs IndexCapillary blood sample will be collected on a dried plasma sample (DPS) filter paper. The sample will be sent to a central laboratory where they will undergo metabolite extraction and analysis via mass spectrometry. | Diagnostic test | Baseline, Concussion |
Primary outcome
Part A: Calculate population reference ranges for 10 phosphatidylcholines (PC) specific to Neurolytixs assay kit.
Time frame: End of Part A (4-6 months)
Population reference values will be determined with the standard definition of a reference range as the interval between which 95% of values of a reference population fall into, in such a way that 2.5% of the time a value will be less than the lower limit of this interval, and 2.5% of the time it will be larger than the upper limit of this interval, whatever the distribution of these values. Measured PC values will be plotted against both sex and the age of participants to which the PCs were measured.
Part A: Generate Area Under the Curve (AUC) values specific to the Neurolytixs assay kit
Time frame: End of Part A (4-6 months)
Generate AUC values for 10 phosphatidylcholines (PCs) for use in Part B
Part B: Determine efficacy of Neurolytixs assay kit for diagnosing adolescent sports concussion
Time frame: 12-72 hours post-injury
The change of at least 1 PC below the cutoff threshold (determined in Part A)
Part B: Determine safety of the Neurolytixs assay kit for adolescent sports concussion
Time frame: Through study completion, up to 1 year
Calculate the number of false negatives (concussions that are not captured by the assay
Part B: Determine safety of the Neurolytixs assay kit for adolescent sports concussion
Time frame: Through study completion, up to 1 year
Calculate the number of false positives identified by the assay
1 secondary outcome
Part B: Determine whether repeated plasma PC measurements over time correlate with injury symptom resolution or clinical recovery
Time frame: 12 weeks post-injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Brain Concussion
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
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.
Douglas D Fraser, MD/PhD principal investigator
Neurolytixs
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurolytixs Index in people with Brain Concussion, run by Neurolytixs at 2 sites in 2 countries.
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 3 inclusion and 3 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 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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 Saoirse Cameron, MA (5198600462, scameron@neurolytixs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Calculate population reference ranges for 10 phosphatidylcholines (PC) specific to Neurolytixs assay kit. (time frame: End of Part A (4-6 months)). The study lists 5 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 4 Apr 2023.