Clinical trials: Sports Concussion
Normative, Concussed
Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes
This study's objectives are: To prospectively examine changes in brain network activation (BNA™) from baseline to recovery (i.e., return to activity) in youth and adolescent athletes with concussion.
- Trial name
- NCT02105935
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Brain Injuries, Traumatic, Concussion, Mild
Validation of Brain Function Assessment Algorithm for mTBI/Concussion
This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms.
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Severe, Concussion, Intermediate
- Trial name
- CAS13-25V (NCT03671083)
- Testing
- BrainScope Ahead 300iP
- Where
- 5 sites in United States
- Volunteers
- 309 people, healthy volunteers welcome
- Sponsor
- BrainScope Company, Inc.
Traumatic Brain Injury, Sports Concussion
A Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes
The purpose of this study is to study the biomarkers in subjects before and after sports-induced traumatic brain injury. The assay will be studied in a sample population of subjects over the age of 18 participating in college…
- Conditions
- Traumatic Brain Injury, Sports Concussion, Sports Injury
- Trial name
- GATOR (NCT01472042)
- Testing
- Banyan Biomarkers
- Where
- United States
- Volunteers
- 265 people, healthy volunteers welcome
- Sponsor
- Banyan Biomarkers, Inc
Brain Concussion
Control Study of Nautilus BrainPulse for the Detection of Concussion
To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's signal patterns with those of concussed high school athletes.
- Trial name
- NCT02350699
- Testing
- Nautilus BrainPulse
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Jan Medical, Inc.
Brain Injuries, Traumatic, Concussion, Mild
Objective Brain Function Assessment of mTBI/Concussion
This study (Part 3) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the…
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Intermediate, Concussion, Severe
- Trial name
- CAS13-25 (NCT03963804)
- Testing
- BrainScope Ahead 300iP
- Where
- 4 sites in United States
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- BrainScope Company, Inc.
Mild Traumatic Brain Injury
Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion
Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport. Despite ongoing research, there is no highly sensitive clinical test for cognitive function.
- Trial name
- NCT01535339
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Minor Traumatic Brain Injury (TBI)
Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth and Adolescents Athletes.
Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion.
- Trial name
- NCT01923441
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Traumatic Brain Injury, Concussion, Brain
Understanding Concussion/Mild Traumatic Brain Injury
Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice.
- Trial name
- NCT03381638
- Testing
- Blink Reflexometer
- Where
- 5 sites in United States
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- Blinktbi, Inc.
Brain Injuries, Traumatic, Concussion, Mild
Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes
This study is Part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms.
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Brain, Concussion, Severe
- Trial name
- CASVAL (NCT02957461)
- Testing
- BrainScope Ahead 200iD
- Where
- 8 sites in United States
- Volunteers
- 420 people
- Sponsor
- BrainScope Company, Inc.
Brain Concussion
Blood Biomarker 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.
- Trial name
- NCT05287997
- Testing
- Neurolytixs Index
- Where
- 2 sites in United States, Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Neurolytixs
Traumatic Brain Injury
Evaluation of Mild TBI in Collegiate Athletes
The purpose of this study is to evaluate blood-based biomarkers before and after sports-induced concussion using neuroimaging and head impact sensor technology.
- Trial name
- AWARE (NCT02189525)
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Banyan Biomarkers, Inc
Mild Traumatic Brain Injury
SSVEP Evaluation of Brain Function
The investigational device used in this clinical investigation, the Nurochek Headset, is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP.
- Trial name
- NCT05614570
- Testing
- SSVEP Device, SCAT5
- Where
- Australia
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- Headsafe MFG
Concussion, Mild
Pro-2-Cool Pivotal Trial II
This study is being conducted to determine the clinical safety and efficacy of Pro-2-Cool mediated head and neck cooling when applied after concussion and improved symptomatology among adolescent athletes as quantified by…
- Trial name
- NCT06929923
- Testing
- Pro2Cool Device
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- TecTraum Inc.
Healthy, Minor Traumatic Brain Injury (TBI)
An Investigator Initiated Study to Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion
Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion.
- Trial name
- NCT01963247
- Where
- United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Concussion
Interactive Training in Sports Concussion Prevention and Management
This study evaluated Brain 101: The Concussion Play book, an intervention that provides education and resources on concussion management for high schools.
- Trial name
- NCT01978795
- Testing
- Brain 101 website, Control
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Oregon Center for Applied Science, Inc.
Brain Injuries, Traumatic, Concussion, Brain
Objective Brain Function Assessment of mTBI/Concussion in High School Athletes
This study (Part 2) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the…
- Conditions
- Brain Injuries, Traumatic, Concussion, Brain, Concussion, Mild, Concussion, Intermediate
- Trial name
- AheadCAS-HS (NCT02661633)
- Testing
- BrainScope Ahead 200iD, Advanced MRI Neuroimaging
- Where
- 4 sites in United States
- Volunteers
- 177 people
- Sponsor
- BrainScope Company, Inc.
Brain Injuries, Traumatic, Concussion, Mild
Objective Brain Function Assessment of mTBI/Concussion in College Athletes
This study (Part 1) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the…
- Conditions
- Brain Injuries, Traumatic, Concussion, Mild, Concussion, Brain, Concussion, Intermediate
- Trial name
- AheadCAS (NCT02477943)
- Testing
- BrainScope Ahead 200iD, Advanced MRI Neuroimaging
- Where
- 11 sites in United States
- Volunteers
- 520 people
- Sponsor
- BrainScope Company, Inc.
Mild Traumatic Brain Injury
SSVEP Evaluation of Brain Function (PRO)
The investigational device used in this clinical investigation, the Nurochek PRO System (NCPRO), is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP.
- Trial name
- NCT06013566
- Testing
- SSVEP
- Where
- Australia
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Headsafe MFG
Minor Traumatic Brain Injury (TBI)
Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion
Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion.
- Trial name
- NCT01759173
- Where
- Canada
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd