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Blood Biomarker
Neurolytixs Index for Concussion
N/A
Recruiting
Led By Douglas D Fraser, MD/PhD
Research Sponsored by Neurolytixs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 1 year
Awards & highlights
Study Summary
This trial aims to develop an objective measurement for diagnosing concussions in adolescent athletes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: Calculate population reference ranges for 10 phosphatidylcholines (PC) specific to Neurolytixs assay kit.
Part A: Generate Area Under the Curve (AUC) values specific to the Neurolytixs assay kit
Part B: Determine efficacy of Neurolytixs assay kit for diagnosing adolescent sports concussion
+1 moreSecondary outcome measures
Part B: Determine whether repeated plasma PC measurements over time correlate with injury symptom resolution or clinical recovery
Other outcome measures
Number of Unanticipated Adverse Device Effects
Part B: Compare proportion of males and females with a change in PC1
Part B: Compare proportion of males and females with a change in PC10
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: ConcussionExperimental Treatment1 Intervention
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.
Group II: BaselineExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
NeurolytixsLead Sponsor
Douglas D Fraser, MD/PhDPrincipal InvestigatorNeurolytixs
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a concussion in the past 6 months.You have a sudden and severe neurological condition.Boys and girls who are 13 to 17 years old, including those who are athletes.
Research Study Groups:
This trial has the following groups:- Group 1: Baseline
- Group 2: Concussion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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