Clinical trials: Mild Traumatic Brain Injury
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
Macula Edema, Radiation Retinopathy
Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole
This phase I trial will assess primarily the safety and secondarily the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory disorders of the…
- Conditions
- Macula Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion, Epiretinal Membrane
- Trial name
- NCT04120636
- Testing
- Episcleral Celecoxib
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Targeted Therapy Technologies, LLC
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, Mild, TBI (Traumatic Brain Injury)
Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment
mTBI is widely recognized as a major public health concern in the United States and worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every concussion.
- Conditions
- Concussion, Mild, TBI (Traumatic Brain Injury), Mild Traumatic Brain Injury
- Trial name
- NCT03265912
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- ElMindA Ltd
Concussion
Concussion Testing: A Novel Non-invasive Concussion Detection Device
The purpose of this study is to establish and evaluate a distinctive signal for concussion.
- Trial name
- NCT02370914
- Testing
- Nautilus NeuroWaveTM System, SCAT
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Jan Medical, Inc.
Concussion, Brain, Mild Traumatic Brain Injury
EyeBOX Concussion Study and Registry
The objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mTBI and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of…
- Trial name
- NCT03966404
- Testing
- EyeBOX device
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Oculogica, 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
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.
Motor Vehicle Accidents, TBI (Traumatic Brain Injury)
Concussion in Motor Vehicle Accidents: The Concussion Identification Index
The primary goal of this study is to provide clinicians with a brief, patient self-administer instrument yielding a single composite score that reliably correlates with objective findings on standardized neurocognitive assessment…
- Conditions
- Motor Vehicle Accidents, TBI (Traumatic Brain Injury), Brain Contusion, Brain Injuries
- Trial name
- CIDI (NCT02858544)
- Testing
- The Concussion Identification Index, ImPACT
- Where
- United States
- Volunteers
- 1,790 people
- Sponsor
- Clionsky Neuro Systems Inc.
Mild Traumatic Brain Injury, Concussion, Binocular Visual Function
An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury
The early prospective study of Traq™ (an investigational binocular ophthalmic neurodiagnostic device) will measure binocular ocular functions (bilateral foveal fixation, foveal binocularity, and fovea-tracked saccadic latency) in…
- Conditions
- Mild Traumatic Brain Injury, Concussion, Binocular Visual Function, Neuro-Ophthalmology, Saccadic Eye Movements
- Trial name
- REB-001 (NCT07742878)
- Testing
- Binocular ophthalmic neurodiagnostic device
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Rebiscan, Inc.
PostTraumatic Stress Disorder, Traumatic Brain Injury
Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Post-Traumatic Stress Disorder
The purpose of this study is to evaluate the safety and efficacy of individualized, Biometrics-guided Magnetic e-Resonance Therapy (MeRT) treatment of Post-Traumatic Stress Disorder
- Conditions
- PostTraumatic Stress Disorder, Traumatic Brain Injury, Postconcussive Symptoms
- Trial name
- MeRT-005-B (NCT02990793)
- Testing
- Active MeRT Treatment
- Where
- 8 sites in United States
- Volunteers
- 158 people
- Sponsor
- Wave Neuroscience
TBI (Traumatic Brain Injury), Concussion, Brain
Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One
The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC)…
- Conditions
- TBI (Traumatic Brain Injury), Concussion, Brain, MTBI - Mild Traumatic Brain Injury, Closed Head Injury
- Trial name
- MEDO (NCT04279431)
- Testing
- EEG Recording, Neurocognitive Tests, Clinician Evaluation
- Where
- 7 sites in United States
- Volunteers
- 660 people
- Sponsor
- BrainScope Company, Inc.
Mild to Moderate Traumatic Brain Injury
PoNS Clinical Experience Program (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
- NCT03852732
- Testing
- PoNS Treatment
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Helius Medical Inc
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
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.
Traumatic Brain Injury, Chronic Balance Disorder
Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)
The purpose of this study is to determine if clinic and home training with a study device will improve a balance deficit. The study device is called Portable Neuromodulation Stimulator (PoNS).
- Trial name
- NCT02429167
- Testing
- Cranial nerve non-invasive neuromodulation via PoNS device
- Where
- 3 sites in United States, Canada
- Volunteers
- 122 people
- Sponsor
- Helius Medical Inc
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
Post Concussive Syndrome, Chronic, Post Concussion Symptoms
Accelerated Transcranial Magnetic Stimulation Intervention for Post-Concussion Syndrome
This study looks at the effects of accelerated intermittent theta burst stimulation (aiTBS) on patients with chronic and acute post-concussion syndrome.
- Conditions
- Post Concussive Syndrome, Chronic, Post Concussion Symptoms, Post Concussive Syndrome, Post Concussion Syndrome
- Trial name
- NCT07211919
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Cognitive FX
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
Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma
The primary objective of the clinical trial is to evaluate the effect of time on levels of Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of head injured…
- Trial name
- VIGILANT (NCT02541123)
- Testing
- Blood draw
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 194 people
- Sponsor
- Banyan Biomarkers, Inc