Blood Biomarker Study to Diagnose Adolescent Sport Concussion

Status Recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Brain Concussion

Clinical Trial Details

NCT number	NCT05287997
Study type	Interventional
Source	Neurolytixs
Contact	Saoirse Cameron, MA
Phone	5198600462
Email	scameron@neurolytixs.com
Status	Recruiting
Phase	N/A
Start date	June 1, 2022
Completion date	December 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02299128` - Effectiveness of Early Physical Therapy Intervention for Patients With Dizziness After a Sports-Related Concussion	N/A
Completed	`NCT02383472` - LED Therapy for the Treatment of Concussive Brain Injury	N/A
Recruiting	`NCT06112093` - Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches	N/A
Terminated	`NCT02597504` - Development of a Neurocognitive Screening Test	N/A
Completed	`NCT00409058` - Teen Online Problem Solving (TOPS) - An Online Intervention Following TBI	N/A
Completed	`NCT00295074` - The Effect of Mild Traumatic Brain Injury on Recovery From Injury	N/A
Completed	`NCT00483444` - Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury	N/A
Completed	`NCT03319966` - Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
Completed	`NCT04681742` - Feasibility Testing of Cognitive Strategy Training in Post-Concussive Syndrome	N/A
Completed	`NCT03759223` - Enhanced Problem-Solving Training	N/A
Completed	`NCT00857207` - Metacognitive Training to Enhance Strategy Use in Blast-Related TBI	N/A
Not yet recruiting	`NCT06131242` - The s100β Levels in Patients With Mild Brain Injury.
Completed	`NCT02368366` - Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI	N/A
Completed	`NCT02858544` - Concussion in Motor Vehicle Accidents: The Concussion Identification Index	N/A
Completed	`NCT00142090` - Use of Salt-Water Solution to Improve Symptoms in Concussion	N/A
Recruiting	`NCT05837676` - Problem-Solving Training for Concussion	N/A
Recruiting	`NCT06015451` - Exercise in Postconcussion Symptoms and Posttraumatic Headache	N/A
Completed	`NCT00724607` - Brain Injury Outcomes (BIO) Study
Unknown status	`NCT02699359` - Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion	N/A
Completed	`NCT02455037` - Evaluation of a Neck Strengthening Program to Reduce the Risk of Sport-related Concussion	N/A