Clinical trials: TBI-Traumatic Brain Injury
Minor Traumatic Brain Injury (TBI)
Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth and Adolescents Athletes.
Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion.
- Trial name
- NCT01923441
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Chronic Traumatic Encephalopathy
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.
- Trial name
- NCT02079766
- Testing
- florbetapir F 18, Flortaucipir F18
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Avid Radiopharmaceuticals
Leg Spasticity
Dysport® Adult Lower Limb Spasticity Study
The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.
- Trial name
- NCT01249404
- Testing
- Botulinum toxin type A
- Where
- 62 sites in United States, Australia and 9 more
- Volunteers
- 388 people
- Sponsor
- Ipsen
Post-Concussion Syndrome
ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion
This is a Phase 1 Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and clinical alleviation of symptoms associated with Post Concussion Syndrome (PCS), also known as Chronic…
- Trial name
- NCT04744051
- Testing
- 50 Adipose Derived Stem Cell Infusion, 150 Adipose Derived Stem Cell Infusion, 300 Adipose Derived Stem Cell Infusion
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- American CryoStem Corporation
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.
Traumatic Brain Injury
Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury
The primary objective of this study is to evaluate the effects of plasticity-based, adaptive cognitive remediation on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with…
- Trial name
- BRAVE (NCT01640158)
- Testing
- Computerized Plasticity-based Adaptive Cognitive Training, Commercially available computerized training
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Posit Science Corporation
Traumatic Brain Injury
A Study of Modified Stem Cells in Traumatic Brain Injury (TBI)
The primary purpose of the clinical study is to evaluate the clinical efficacy of intracranial administration of SB623 cells on patients with chronic motor deficit from Traumatic Brain Injury.
- Trial name
- STEMTRA (NCT02416492)
- Testing
- SB623 cells
- Where
- 36 sites in United States, Japan and 1 more
- Volunteers
- 63 people
- Sponsor
- SanBio, Inc.
Traumatic Brain Injury
Clinical Evaluation of the i-STAT TBI Test
The goal of this study is to evaluate the i-STAT TBI test to assist determining the need for a computed tomography (CT) scan in patients with suspected mild traumatic brain injury (TBI).
- Trial name
- NCT04171960
- Testing
- Blood draw, Outcome assessments
- Where
- 21 sites in United States
- Volunteers
- 1,106 people
- Sponsor
- Abbott Point of Care
Brain Injuries, Concussion, Mild
Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
This study is designed to collect data which will be used to associate changes in EEG, neurocognitive performance, eNPC and clinical symptoms in concussion subtypes.
- Conditions
- Brain Injuries, Concussion, Mild, Concussion, Brain, Near Point Convergence
- Trial name
- BSC-CI-NPC (NCT04074486)
- Testing
- BrainScope Ahead 300iP-O, SCAT5, Near Point Convergence
- Where
- 6 sites in United States
- Volunteers
- 1,318 people, healthy volunteers welcome
- Sponsor
- BrainScope Company, Inc.
Brain Injuries, Traumatic
Brain Injury Biomarkers in the General Population
The purpose of this study is to use an investigational assay to assess levels of putative biomarkers of traumatic brain injury (TBI) in a general population.
- Trial name
- NCT01786460
- Testing
- Blood draw at Days 0, 7, 14, and 21
- Where
- 5 sites in United States
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Banyan Biomarkers, 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.
Post-Concussive Syndrome, Chronic, Post-Concussion Syndrome
Impact of Photobiomodulation on Objective, Physiological Measures of Brain Function in Individuals With Post-Concussion Syndrome
Photobiomodulation therapy (PBMT) uses light to influence the mitochondria of cells. PBMT of the brain enhances the metabolic capacity of neurons and stimulates anti-inflammatory, anti-apoptotic, and antioxidant responses, as…
- Conditions
- Post-Concussive Syndrome, Chronic, Post-Concussion Syndrome, Mild Traumatic Brain Injury
- Trial name
- NCT05097222
- Testing
- BioFlex Dualport System
- Where
- 2 sites in Canada
- Volunteers
- 19 people
- Sponsor
- Dr George Medvedev
Memory Deficit Aquired Due to the Disease, e.g. Stroke, Neurodegeneration, Inflammatory Disease of CNS, Traumatic Brain Injury
Vestibular Stimulation in Sleep for Neurorehabilitation Patients
1. Why are we conducting this study? You are a patient of the neurorehabilitation clinic with one of the therapy focuses on memory and learning. Neuropsychological training is a standard therapeutic approach in this case.
- Trial name
- NCT07658027
- Testing
- Somnomat - rocking bed providing vestibular stimulation during sleep
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- Cereneo AG
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
Traumatic Brain Hemorrhage
SAFETY: Stabilization Points to Third Hospital Line Assessment oF the Impact of the usE of Infrascanner Model 2500 to Provide Decision Support for Diagnosis/Screening of Traumatic Brain InjurY in Ukraine
The Infrascanner model 2500 is a handheld, noninvasive device that is FDA-cleared to detect traumatic intracranial hematomas. FDA clearance K200203 was issued in 2020, K211617 added pediatric age group to the IFU in 2022, and…
- Trial name
- SAFETY (NCT07014748)
- Testing
- Handheld brain hematoma detector
- Where
- 4 sites in United States, Ukraine
- Volunteers
- 600 people
- Sponsor
- InfraScan, Inc.
ALS (Amyotrophic Lateral Sclerosis), TBI Traumatic Brain Injury
Augmented Reality BCI Longitudinal Study for Persons With ALS, Stroke, TBI and SCI Utilizing Cognixion + Apple Vision Pro
The goal of this study is refine the usability of a BCI capable communication platform. The study will take place in the United States area and will enroll up to 10 participants with late stage ALS, traumatic brain injury (TBI)…
- Conditions
- ALS (Amyotrophic Lateral Sclerosis), TBI Traumatic Brain Injury, SCI - Spinal Cord Injury, Stroke
- Trial name
- NCT07209943
- Testing
- Cognixion + Apple Vision Pro
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cognixion
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
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
Intracranial Hemorrhages, Traumatic Brain Injury
Evaluate the SENSE Device's Ability to Monitor and Detect Intracranial Hemorrhage
This study is a two-stage, pivotal, prospective, non-randomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scan in patients with a diagnosis of primary spontaneous ICH…
- Trial name
- NCT04642443
- Testing
- SENSE Device
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- Sense Diagnostics, LLC