Clinical trials: Traumatic Brain Injury, Mild
Mild Traumatic Brain Injury
HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma
The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in the diagnosis and prognosis of patients with…
- Trial name
- HeadSMART II (NCT04423198)
- Testing
- Cognitive Assessment, Patient Reported Neurological Outcome Assessments, Blood Draw
- Where
- 11 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- BRAINBox Solutions Inc
Brain Concussion, Vestibular Disorder
Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI
The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with…
- Conditions
- Brain Concussion, Vestibular Disorder, Cognition Disorder, Mild Traumatic Brain Injury
- Trial name
- Praxis (NCT06314464)
- Testing
- Praxis, Supervised cardiovascular exercise
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- BlueHalo
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.
Mild Traumatic Brain Injury, Concussion
Advancement of Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
The goal is to assess the potential benefit of stochastic galvanic vestibular stimulation (sGVS) in improving patient performance with respect to balance, gait, and/or overall vestibular function for individuals with known…
- Trial name
- NCT07466589
- Testing
- Stochastic Galvanic Vestibular Stimulation (sGVS)
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Vivonics, Inc.
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, Intracranial Lesions
TES HT100 Clinical Validation for Brain Injury Screening in Patients With Mild Head Trauma or Neurological Symptoms
The goal of this clinical study is to evaluate how accurately and safely the TES HT100 device can identify intracranial abnormalities in adult emergency department patients with mild head trauma or neurological symptoms that are…
- Conditions
- Mild Traumatic Brain Injury, Intracranial Lesions, Neurological Symptoms Not Related to Head Trauma
- Trial name
- TESCO (NCT07490418)
- Testing
- Temnographic Brain Screening Examination
- Where
- 3 sites in Italy, Poland
- Volunteers
- 850 people
- Sponsor
- B&B srl
Brain Injuries, Traumatic
Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury
Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan.
- Trial name
- NCT05092295
- Testing
- Head and Intraocular Trauma Tool, SCAT-5
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Rebiscan, Inc.
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
Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI
This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the safety and efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software…
- Trial name
- CogMind (NCT02922569)
- Testing
- Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training, Mindfulness Training
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Posit Science Corporation
Brain Concussion, Cerebral Concussion
Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED)…
- Conditions
- Brain Concussion, Cerebral Concussion, Concussion, Intermediate, Concussion, Mild
- Trial name
- DETECT (NCT02776462)
- Testing
- EyeBox CNS
- Where
- 2 sites in United States
- Volunteers
- 321 people
- Sponsor
- Oculogica, Inc.
Concussion, Brain, Mild Traumatic Brain Injury
Oculogica Portable EyeBOX Study
The objective of this study is to assess the accuracy of a portable version of the EyeBOX device, an eye-tracking based diagnostic, in comparison to a clinical reference standard of concussion.
- Trial name
- RESTLESS (NCT05047003)
- Testing
- EyeBOX Model EBX-4 (Portable version)
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- Oculogica, Inc.
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.
Mild Traumatic Brain Injury
Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury
The main objective of this interdisciplinary study is to develop an understanding of the molecular imaging features of blast-related mild traumatic brain injury (mTBI) in military personnel, while helping to establish assessment…
- Trial name
- NCT05337774
- Testing
- [18F]PI-2620
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Life Molecular Imaging SA.
Mild Traumatic Brain Injury, Concussion
A Randomised, Double-blind, Placebo-controlled Phase 2a Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONP-002 in Adults With Mild Traumatic Brain Injury
This is a Phase IIa, randomized, double-blind, placebo-controlled pilot study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ONP-002 in adults with mild traumatic brain injury (mTBI).
- Trial name
- NCT06870240
- Testing
- Neurosteroid enantiomer
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- Oragenics, Inc.
Traumatic Brain Injury
Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
- Trial name
- NCT00893789
- Testing
- Armodafinil
- Where
- 73 sites in United States, Germany and 2 more
- Volunteers
- 117 people
- Sponsor
- Cephalon, 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.
Concussion, Brain, Mild Traumatic Brain Injury
A Highly Portable Device for Assessment of Mild Traumatic Brain Injury in Deployed and Far-Forward Settings
The purpose of this study is to develop a highly portable, ruggedized diagnostic tool for concussion, EyeBOX Lens (EBLens), that can be utilized in deployed field and far-forward settings.
- Trial name
- NCT05527041
- Testing
- EyeBOX Lens (EBLens)
- Where
- United States
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- Oculogica, Inc.
Brain Injuries, Traumatic
Biomarkers of Mild and Moderate Traumatic Brain Injury
The purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools.
- Trial name
- NCT01295346
- Testing
- Head CT scan and blood draw
- Where
- 7 sites in United States, Hungary
- Volunteers
- 290 people
- Sponsor
- Banyan Biomarkers, Inc
Mild to Moderate Traumatic Brain Injury
PoNS Clinical Experience Program in Traumatic Brain Injury Patients (TBI)
Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI).
- Trial name
- NCT03881176
- Testing
- PoNS Treatment
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Helius Medical Inc
TBI (Traumatic Brain Injury)
Traumatic Brain Injury in Veterans and Near-Infrared Phototherapy
This is a proof-of-concept study designed to demonstrate whether increases in cerebral blood flow, improvements in brain functioning, and reductions in symptomology associated with traumatic brain injury (TBI) can result from…
- Trial name
- NCT02635516
- Testing
- Near-Infrared Phototherapy
- Volunteers
- 13 people
- Sponsor
- Cerehealth Corp.