Clinical trials: Injuries, Head
- Condition Injuries, Head
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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.
Zygomatic Fractures, Orbital Fractures
Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up
A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting.
- Conditions
- Zygomatic Fractures, Orbital Fractures, Maxilla Fractures, Facial Fractures
- Trial name
- UMF (NCT07245719)
- Testing
- Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Stryker Craniomaxillofacial
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.
Healthy
Normative Oculomotor and Vestibular Data in Pediatric Population
The purpose of this study is to use a device called I-Portal® Portable Assessment System (I-PAS) to record eye movements in response to a number of visual and auditory stimuli designed to evaluate neural brain pathways related to…
- Trial name
- NCT04107610
- Testing
- I-PAS
- Where
- 2 sites in United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Neurolign
Brain Concussion, Mild Cognitive Impairment
Development of a Neurocognitive Screening Test
This research study will evaluate a standalone software application and is designed to standardize and validate new neurocognitive screening testing for children aged 6 through 11, and adolescents and adults ages 12 through 75.
- Trial name
- NCT02597504
- Testing
- Pen and paper neuropsychological test, Quick Test
- Where
- 4 sites in United States
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- ImPACT Applications, Inc.
Degenerative Conditions of the Radial Head/Neck, Post-traumatic Conditions of the Radial Head/Neck
ExploR® Modular Radial Head Data Collection
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR® Modular Radial Head. This data collection effort will document the clinical outcomes of the radial head.
- Trial name
- NCT00533234
- Testing
- ExploR® Modular Radial Head
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Biomet Orthopedics, LLC
Traumatic Brain Injury
Crainio Non-invasive ICP Monitor for TBI
The clinical investigation aims to advance the Crainio device, designed for non-invasive intracranial pressure (ICP) monitoring.
- Trial name
- NCT06453733
- Testing
- Crainio
- Where
- United Kingdom
- Volunteers
- 54 people
- Sponsor
- Crainio Ltda
Mandibular Fractures, Facial Fracture
Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up
A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting.
- Conditions
- Mandibular Fractures, Facial Fracture, Maxilla Fracture, Orthognathic Surgical Procedures
- Trial name
- UPC (NCT07245810)
- Testing
- Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery
- Where
- 2 sites in United States
- Volunteers
- 726 people
- Sponsor
- Stryker Craniomaxillofacial
Brain Injuries, Traumatic
HITT for the Identification of Mild Traumatic Brain Injury
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
- NCT05092282
- Testing
- Head and Intraocular Trauma Tool, SCAT-5
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Rebiscan, Inc.
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
Orthognathic Surgery, Maxillofacial Abnormalities
Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for…
- Conditions
- Orthognathic Surgery, Maxillofacial Abnormalities, Maxilla Fracture
- Trial name
- CMF-ORTHO (NCT05271383)
- Testing
- Orthognathic surgery using Global D's implants.
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Global D
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, Concussion, Brain
Objective Brain Function Assessment of mTBI/Concussion in High School Athletes
This study (Part 2) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the…
- Conditions
- Brain Injuries, Traumatic, Concussion, Brain, Concussion, Mild, Concussion, Intermediate
- Trial name
- AheadCAS-HS (NCT02661633)
- Testing
- BrainScope Ahead 200iD, Advanced MRI Neuroimaging
- Where
- 4 sites in United States
- Volunteers
- 177 people
- Sponsor
- BrainScope Company, Inc.
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.
Ocular Injury
An Observational, Qualitative Study Assessing Eye Drop Administration
This is a prospective, observational, consecutive, qualitative, multicenter study. Based on the available published evidence that supports patient challenges with eyedrop administration, the purpose of this video-capture study is…
- Trial name
- NCT05307081
- Testing
- Artificial Tears
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Ocular Therapeutix, Inc.
Mild Traumatic Brain Injury
Un-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
The primary objective of this study is to collect un-blinded BrainPulse recordings from youth and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to improve a concussion detection algorithm…
- Trial name
- NCT02849002
- Testing
- BrainPulse
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- Jan Medical, 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 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, Mild, Concussion; Eye
EYE-SYNC Concussion Classification Study
The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion…
- Conditions
- Concussion, Mild, Concussion; Eye, Concussion, Brain, Concussion, Severe
- Trial name
- NCT04381767
- Testing
- EYE-SYNC
- Where
- United States
- Volunteers
- 1,303 people
- Sponsor
- Sync-Think, Inc.
Cerebral Palsy, Acquired Brain Injury
Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease
The goal of this clinical trial is to analyze the usability and safety of the prototype gait exoskeleton EXPLORE V2 in children with neurological and neuromuscular disease.
- Conditions
- Cerebral Palsy, Acquired Brain Injury, Neuromuscular Diseases in Children
- Trial name
- NCT05914818
- Testing
- EXPLORER V2
- Where
- 5 sites in Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- MarsiBionics