Clinical trials: Close Head Injury
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.
Acute Concussion Syndrome
Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
This is a controlled investigation, with randomization of the patients, which aims at evaluating the safety and performance of device RGn550 in treating sportspeople suffering from acute concussion syndrome.
- Trial name
- RECOVERY (NCT05647304)
- Testing
- RGn550 5 Hz-PWM, RGn550 10 Hz-PWM
- Where
- France
- Volunteers
- 50 people
- Sponsor
- REGEnLIFE SAS
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, 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
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.
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
Concussion
ImPACT Version 4-Touchscreen: Normative and Reliability Study
This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen.
- Trial name
- NCT05551520
- Testing
- Normative, Reliability
- Where
- United States
- Volunteers
- 1,437 people, healthy volunteers welcome
- Sponsor
- ImPACT Applications, Inc.
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
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
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
Severe Head Trauma
Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8).
- Trial name
- ABELADRUG200 (NCT00810940)
- Testing
- AbelaDrug200, mannitol
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Abela Pharmaceuticals, Inc.
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.
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
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
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