Clinical trials: Traumatic Brain Injury, Mild
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
- NCT03881202
- Testing
- PoNS Treatment
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Helius Medical 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.
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, Concussion, Mild
Rapid Biochemical Diagnostics of Traumatic Brain Injury
The objective of the study is to confirm the clinical relevance of the novel biomarker for traumatic brain injury (TBI) detection.
- Conditions
- Traumatic Brain Injury, Concussion, Mild, Bone Fracture
- Trial name
- NCT03306563
- Testing
- Sample collection
- Where
- 3 sites in Finland
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Medicortex Finland Oy
Concussion, Mild, Concussion, Intermediate
Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event
This study is designed to evaluate the use of a collection of tests that measure the eye response, balance, oculomotor and reaction time tests to aid in the diagnosis of mTBI.
- Conditions
- Concussion, Mild, Concussion, Intermediate, Concussion, Severe
- Trial name
- NKI-RIF1 (NCT01832714)
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Neurolign
Traumatic Brain Injury
NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury
A Randomized Double-blind, Placebo-controlled, Multi-center Trial to determine the efficacy of NeuroAiD II™ (MLC901) in improvement of cognitive functioning of adult patients with long-term cognitive impairment following mild…
- Trial name
- SAMURAI (NCT04861688)
- Testing
- Traditional Chinese Medicine (NeuroAiD II™ (MLC901)
- Where
- 4 sites in Russia
- Volunteers
- 182 people
- Sponsor
- Moleac Pte Ltd.
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.
Brain Concussion, Mild Traumatic Brain Injury
Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
The multi-center study evaluates BrainPulse recordings from subjects with a suspected or confirmed concussion to improve a concussion detection algorithm.
- Trial name
- NCT02812225
- Testing
- BrainPulse
- Where
- 3 sites in United States
- Volunteers
- 406 people
- Sponsor
- Jan Medical, Inc.
MTBI - Mild Traumatic Brain Injury
Retraining Neural Pathways Improves Cognitive Skills After A Mild Traumatic Brain Injury
The proposed study tests the efficacy (Phase II) of 36 or 54 30-minute training sessions of PATH neurotraining followed by digit memory exercises to improve working memory, processing speed and attention in mTBI patients rapidly…
- Trial name
- NCT03655782
- Testing
- PATH + DigitMemory (DM) neurotraining
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Perception Dynamics Institute
Brain Injuries, Traumatic
Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
The study will enroll children and adolescents (0 - 17 years) suspected of having concussion or mild traumatic brain injury (TBI).
- Trial name
- NCT04288167
- Testing
- Sample collection
- Where
- Finland
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Medicortex Finland Oy
Brain Injuries, Traumatic
mTBI Identification and Monitoring Through Retinal Scanning
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
- NCT06142435
- Testing
- Head and Intraocular Trauma Tool
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Rebiscan, 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
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
- NCT03882554
- Testing
- PoNS Treatment
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Helius Medical Inc
Traumatic Brain Injury
Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury…
- Trial name
- NCT00983437
- Testing
- Armodafinil
- Where
- 61 sites in United States
- Volunteers
- 49 people
- Sponsor
- Cephalon, 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
Mild Traumatic Brain Injury
VIDAS® TBI Real Life Performance in Subjects With Mild Traumatic Brain Injury (mTBI)
Decision Rules for an initial CT-scan in patients arriving to Emergency Department (ED) and presenting a mild traumatic brain injury could be optimized by the use of an objective parameter easily and rapidly measured.
- Trial name
- NCT06449183
- Testing
- VIDAS® TBI Test [GFAP and UCH-L1 assays]
- Where
- 5 sites in United States
- Volunteers
- 903 people
- Sponsor
- BioMérieux
Concussion
A Safety and Efficacy Study of NNZ-2566 in Patients With Mild Traumatic Brain Injury (mTBI)
The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the treatment of mTBI in adolescents and adults.
- Trial name
- NCT02100150
- Testing
- NNZ-2566
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Neuren Pharmaceuticals Limited
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.
Traumatic Brain Injury
TBI MR Study 3 Houston Methodist
This hypothesis-generating feasibility study to determine potential associations between a broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and clinical findings involved in mild traumatic…
- Trial name
- NCT02218216
- Testing
- MRI Diagnostic
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- GE Healthcare
Brain Concussion, Brain Injuries
An Evaluation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion
The HeadSense (HS) HS-1000 device, a new non-invasive brain monitor is expected to safely and accurately monitor concussed patients with minimal discomfort, potentially providing a new modality for concussion measurement.
- Trial name
- NCT02699346
- Testing
- HS-1000 recording
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- HeadSense Medical