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

No Placebo-Only Group

Summary

This trial aims to develop an objective measurement for diagnosing concussions in adolescent athletes.

Eligible Conditions

Concussion

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Part B: Determine whether repeated plasma PC measurements over time correlate with injury symptom resolution or clinical recovery

Other study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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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