Clinical trials: mTBI
MTBI - Mild Traumatic Brain Injury, Concussion, Mild
Evaluation of Helmet Technology and Head Impact Exposure
The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of football playing athletes grouped by helmet make and model.
- Trial name
- NCT03883451
- Testing
- Helmet Model
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Concussion, Brain, Motor Vehicle Accident
Research Evaluating Sports ConcUssion Events - Rapid Assessment of Concussion and Evidence for Return
RESCUE-RACER is jointly sponsored by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust. The RESCUE-RACER programme evaluates motorsports competitors at baseline (CArBON) and post-injury (CARS).
- Trial name
- RESCUE-RACER (NCT03844282)
- Testing
- Clinical assessment (SCAT5), ImPACT, CANTAB
- Where
- United Kingdom
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- University of Cambridge
Concussion
Vascular Assessment of Regulation Index Arrays Registry
The objective of this patient registry is to collect and analyze physiological data associated with baseline and brain injury identified in standard clinical practice (Normal Values, Recovery Curves, Correlation between Symptoms…
- Trial name
- VARIA (NCT02435082)
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- NeuroChaos Solutions, Inc.
mTBI - Mild Traumatic Brain Injury
MindRhythm Detection of Concussion and Recovery Study
This study is designed to observe HeadPulse data in concussed subjects that may have experienced a concussion via an injury down to the age of 4.
- Trial name
- DISCOVERY (NCT07190963)
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- MindRhythm, Inc.
Concussion
Driving Performance of Teenage Patients With mTBI: a Longitudinal Assessment
This study will synthesize a behavioral profile of impaired driving performance for teenage patients with mild traumatic brain injury (mTBI), or concussion, from one week post-concussion to six weeks post-concussion.
- Trial name
- NCT02278029
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Concussion, Brain
Objective Concussion Assessment Using MRI and Metabolomics
Mild traumatic brain injury (mTBI), also referred to as concussions, affect millions of people around the world and can cause harmful long term effects.
- Trial name
- NCT05993351
- Testing
- Magnetic resonance imaging (MRI), Urine and saliva samples, Questionnaires
- Where
- Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- St. Joseph's Healthcare Hamilton
Concussion, Traumatic Brain Injury
Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between…
- Trial name
- mTBI-phase2 (NCT02556177)
- Testing
- MRI
- Where
- 7 sites in United States
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Traumatic Brain Injury
Comparison of Brain Network Activation (BNA™) Analysis, Clinical Symptoms and Neuro-cognitive Performance in Concussed Children and Young Adults
The use of Event Related Potentials (ERP) and neurocognitive performance in patients following concussion has been examined previously in small cohorts and relatively long after concussion occurred.
- Trial name
- NCT01532271
- Where
- United States
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
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, Concussion, Mild
Exercise as Concussion Therapy Trial- 2
This study is a Phase 2, open-label study of a therapeutic intervention (graded exercise)compared to a reference therapy (passive stretching) in patients who have sustained mTBI.
- Trial name
- ExACTT (NCT04578743)
- Testing
- Graded Exercise Therapy: ClearPlay(TM)
- Where
- 3 sites in Australia
- Volunteers
- healthy volunteers welcome
- Sponsor
- ANSwers Neuroscience, 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
MTBI - Mild Traumatic Brain Injury
Imaging of Injury Mechanism and Interaction of Intestinal Bacteria in Children With Mild Traumatic Brain Injury
Traumatic brain injury (TBI) is the leading cause of disability in children and young adults. Children with moderate to severe TBI are typically at risk of poor functional outcome in terms of neurocognitive impairment and…
- Trial name
- NCT05090007
- Testing
- magnetic resonance image, gut microbiota
- Where
- China
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Concussion, Traumatic Brain Injury
Concussion Device Audiological Measures
Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from…
- Trial name
- NCT02262507
- Testing
- Device Wearing
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Mild Traumatic Brain Injury
A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion
The main purpose of this study is to prospectively examine changes in Brain Network Activation(BNA)following concussion in high school athletes.
- Trial name
- NCT01673464
- Where
- United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
MTBI - Mild Traumatic Brain Injury, Concussion, Mild
Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar
The purpose of the study is to monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football and soccer playing athletes wearing the Device and compared to a similar population…
- Trial name
- NCT04068883
- Testing
- Q collar
- Where
- 2 sites in United States
- Volunteers
- 488 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Concussion (Diagnosis), MTBI - Mild Traumatic Brain Injury
BCAAs in Concussion 3.0
This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAAs) in the treatment of concussion.
- Conditions
- Concussion (Diagnosis), MTBI - Mild Traumatic Brain Injury, Concussion, Brain, Concussion
- Trial name
- NCT07670195
- Testing
- BCAA
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Akiva Cohen
Concussion, Mild Traumatic Brain Injury
Implementation of an Evidence-Based Educational Resource for Children With Mild Traumatic Brain Injury
The goal of this prospective, observational study is to (1) collaborate with our stakeholders to identify essential mTBI-information from existing evidence-based materials to develop a Post-mTBI Educational Resource for children…
- Trial name
- POCKIT (NCT07414303)
- Testing
- Post-mTBI Educational Resource
- Where
- 3 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Baylor Research Institute
Concussion, Brain Trauma
Field Implementation of iDETECT
The purpose of this study is to assess a new screening tool for sideline evaluation of concussion injuries in athletes. iDETECT is a new technology that combines several elements of recommended concussion screening tools into a…
- Trial name
- NCT02529618
- Testing
- integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT), Riddell High Impact Technology (HIT) System, i1 Biometrics Vector Mouth Guard
- Where
- 4 sites in United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Emory University
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.
Mild Traumatic Brain Injury, Traumatic Brain Injury
Advanced MRI Applications for Mild Traumatic Brain Injury
This feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and magnetic resonance images (MRI), data, and clinical findings involved in mild traumatic…
- Trial name
- TBI (NCT02070588)
- Testing
- MRI
- Where
- United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- GE Healthcare