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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

Male or female athletes, aged 13-17 inclusive

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Boys and girls who are 13 to 17 years old, including those who are 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

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

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 more

Secondary 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 more

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

NeurolytixsLead Sponsor

Douglas D Fraser, MD/PhDPrincipal InvestigatorNeurolytixs

Media Library

Neurolytixs Index (Blood Biomarker) Clinical Trial Eligibility Overview. Trial Name: NCT05287997 — N/A

Concussion Research Study Groups: Baseline, Concussion

Concussion Clinical Trial 2023: Neurolytixs Index Highlights & Side Effects. Trial Name: NCT05287997 — N/A

Neurolytixs Index (Blood Biomarker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05287997 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 45 and over eligible for recruitment into this experiment?

"This research is aiming to include participants aged between 13 and 17 years."

Answered by AI

What prerequisites must be fulfilled to participate in this clinical research?

"To be eligible to enroll, applicants must have suffered a concussion and range in age from 13 to 17. In total, 150 participants are being recruited for this trial."

Answered by AI

Are there any available slots in this scientific investigation?

"Clinicaltrials.gov provides information to support that this research project, which was first listed on June 1st 2022, is actively seeking participants. Up-to-date data from March 31st 2023 also exists for the experiment."

Answered by AI

How many participants have enrolled in this experiment?

"Affirmative. The information available on clinicaltrials.gov illustrates that this scientific inquiry opened for recruitment in June 2022 and was recently updated at the end of March 2023. 150 patients need to be enlisted between two sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Blood Biomarker Study to Diagnose Adolescent Sport Concussion

2022. "Blood Biomarker Study to Diagnose Adolescent Sport Concussion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05287997.

All > Concussion