Clinical trials: Trauma, Brain
Mild Traumatic Brain Injury
Pro-2-Cool Device Clinical Study
This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling when applied up to 8 days after mild traumatic brain injury (mTBI) among adolescents participating in sporting activities.
- Trial name
- NCT03511339
- Testing
- TecTraum device
- Where
- 5 sites in United States
- Volunteers
- 174 people
- Sponsor
- TecTraum Inc.
Gait Impairment, Cerebral Palsy (CP)
Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program…
- Conditions
- Gait Impairment, Cerebral Palsy (CP), Neuromuscular Diseases (NMD), Spinal Cord Injuries (SCI)
- Trial name
- NCT07745712
- Testing
- ABLE Kids
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- ABLE Human Motion S.L.
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.
Concussion
Vascular Assessment of Regulation Index Arrays Registry
The objective of this patient registry is to collect and analyze physiological data associated with baseline and brain injury identified in standard clinical practice (Normal Values, Recovery Curves, Correlation between Symptoms…
- Trial name
- VARIA (NCT02435082)
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- NeuroChaos Solutions, Inc.
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates 2
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their…
- Trial name
- BANON2 (NCT04714775)
- Where
- 13 sites in Germany, Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- InfanDx AG
Traumatic Brain Injury, Intracranial Hypertension
A Non-invasive Intracranial Pressure (nICP) Monitoring System
Researchers have developed a probe that contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe.
- Trial name
- NCT05632302
- Testing
- nICP
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Crainio Ltda
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.
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
Interactive Training in Sports Concussion Prevention and Management
This study evaluated Brain 101: The Concussion Play book, an intervention that provides education and resources on concussion management for high schools.
- Trial name
- NCT01978795
- Testing
- Brain 101 website, Control
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Oregon Center for Applied Science, Inc.
Periventricular Leukomalacia, White Matter Disease
Cell-Based Therapy for White Matter Repair in Periventricular Leukomalacia
The goal of this study is to explore a new treatment that may help repair brain damage in individuals with periventricular leukomalacia (PVL), a condition that affects white matter in the brain.
- Conditions
- Periventricular Leukomalacia, White Matter Disease, Hypoxic-Ischemic Encephalopathy, Demyelinating Diseases
- Trial name
- NCT06985303
- Testing
- Investigational Combination Product
- Sponsor
- MGAM LLC
Traumatic Encephalopathies, Chronic, Concussion, Mild
Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
Concussion is the most common type of brain injury throughout life. Study is seeking improvement of long-term residua following adolescent and adult post-traumatic injuries often associated with contact sports and accidental…
- Conditions
- Traumatic Encephalopathies, Chronic, Concussion, Mild, Concussion, Intermediate, Concussion, Severe
- Trial name
- C-TBI (NCT02959294)
- Testing
- Microcannula Harvest Adipose, Centricyte 1000, Sterile Normal Saline IV deployment AD-cSVF
- Where
- United States
- Sponsor
- Robert W. Alexander, MD, FICS
Asperger's Syndrome, Dyslexia
My Scrivener® - Measuring Effectiveness and Dose Response in Children
This study will assess whether a computer haptic peripheral device programmed to provide repetitive motion training is as effective as the same repetitive motion training provided by a human being.
- Conditions
- Asperger's Syndrome, Dyslexia, Cerebral Palsy, Attention Deficit Disorder
- Trial name
- NCT00919906
- Testing
- My Scrivener(R)
- Where
- United States
- Volunteers
- 176 people
- Sponsor
- Obslap Research LLC
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.
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, 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.
Head Injury
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial…
- Trial name
- NCT01824589
- Testing
- -7 cm H2O ITPR, -12cm H2O ITPR
- Volunteers
- 1 people
- Sponsor
- Advanced Circulatory Systems
Healthy, Minor Traumatic Brain Injury (TBI)
An Investigator Initiated Study to 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
- NCT01963247
- Where
- United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Mild Traumatic Brain Injury
SSVEP Evaluation of Brain Function (PRO)
The investigational device used in this clinical investigation, the Nurochek PRO System (NCPRO), is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP.
- Trial name
- NCT06013566
- Testing
- SSVEP
- Where
- Australia
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Headsafe MFG
Concussion, Traumatic Brain Injury
Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between…
- Trial name
- mTBI-phase2 (NCT02556177)
- Testing
- MRI
- Where
- 7 sites in United States
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Intracranial Hypertension, Brain Injuries
An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device
Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head.
- Conditions
- Intracranial Hypertension, Brain Injuries, Stroke, Hydrocephalus
- Trial name
- NCT02773888
- Testing
- HS-1000
- Where
- 5 sites in Japan
- Volunteers
- 80 people
- Sponsor
- HeadSense Medical