Clinical trials: Mild Traumatic Brain Injury
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.
Concussion, Brain
EEG-guided Cognitive Pacing Tool During Concussion Recovery
This investigation will assess the utility of a novel wearable electroencephalography (EEG) headband linked to a mobile application to monitor cognitive activity post-concussion, and alert a patient when it is time to take a…
- Trial name
- NCT05522855
- Testing
- EEG Sensorband and mobile application
- Volunteers
- 50 people
- Sponsor
- Dr. Matthew Kennedy
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
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
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.
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 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
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
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
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.