Clinical trials: Head Injury Trauma
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.
Traumatic Brain Injury
Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)
Nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve sleep and next-day functioning in CP (cerebral palsy)…
- Trial name
- NCT00287157
- Testing
- Sublingual Tizanidine HCl
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- Teva GTC
Brain Concussion, Cerebral Concussion
Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
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 the Emergency Department (ED)…
- Conditions
- Brain Concussion, Cerebral Concussion, Concussion, Intermediate, Concussion, Mild
- Trial name
- DETECT (NCT02776462)
- Testing
- EyeBox CNS
- Where
- 2 sites in United States
- Volunteers
- 321 people
- Sponsor
- Oculogica, Inc.
Burning Eye, Irritation; Eyeball
Vit-A-Vision® Clinical Investigation
Symptoms of ocular discomfort include dryness, burning, stinging, photophobia, foreign body sensation and contact lens intolerance.
- Conditions
- Burning Eye, Irritation; Eyeball, Tired Eye, Dry Eye Disease
- Trial name
- NCT06596733
- Testing
- Vit-A-Vision
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- OmniVision GmbH
Non-arteritic Ischemic Optic Neuropathy, Optic Nerve Injuries
Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the…
- Trial name
- NCT02045212
- Testing
- RPh201
- Where
- Israel
- Volunteers
- 22 people
- Sponsor
- Regenera Pharma Ltd
Traumatic Brain Injury, Cerebral Edema
Safety and Efficacy of ABX-101 in Participants Aged 18 to 50 Years of Age With Moderate to Severe Traumatic Brain Injury
The purpose of this study is to investigate the clinical improvement measured by the Glasgow Outcome Scale Extended (GOS-E) with ABX-101 compared with Placebo intramuscular injection in participants with moderate to severe TBI.
- Trial name
- NCT06096415
- Testing
- ABX-101 1mg, ABX-101 2mg
- Volunteers
- 45 people
- Sponsor
- Abalonex, LLC
Chronic Subdural Hematomas
PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial
This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to…
- Trial name
- PHILFIRST (NCT07576998)
- Testing
- PHIL™ (Precipitating Hydrophobic Injectable Liquid), Surgical evacuation
- Volunteers
- 475 people
- Sponsor
- Microvention-Terumo, Inc.
Traumatic Brain Injury (TBI) Patients, Stroke Hemorrhagic
Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System
The goal of this observational study is to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) pulse morphology and associated parameters (such as the P2/P1 ratio and…
- Conditions
- Traumatic Brain Injury (TBI) Patients, Stroke Hemorrhagic, Stroke Ischemic
- Trial name
- NCT07210333
- Testing
- non-invasive intracranial pressure monitoring
- Where
- 3 sites in Brazil
- Volunteers
- 300 people
- Sponsor
- Braincare USA Corp
Traumatic Brain Injury
Dexanabinol in Severe Traumatic Brain Injury
Each year a large number of patients are hospitalized at Shock Trauma Centers with severe head injuries. Bleeding into and swelling of these patients' brains may cause compression of vital structures, disability and death.
- Trial name
- NCT00129857
- Testing
- Dexanabinol
- Volunteers
- 860 people
- Sponsor
- Pharmos
Dural Defect, Cerebrospinal Fluid Leak
Immiseal™ Dural Sealant Post-Market Registry Study
This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct…
- Conditions
- Dural Defect, Cerebrospinal Fluid Leak, Neurosurgical Procedures
- Trial name
- NCT07651826
- Where
- Latvia
- Volunteers
- 85 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
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.
Minor Traumatic Brain Injury (TBI)
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
- NCT01759173
- Where
- Canada
- Volunteers
- 234 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.
Traumatic Brain Injury (TBI)
Monitoring the Alterations That Occur in the Brain Following Traumatic Brain Injury
This project, will combine the data collected from existing and innovative technologies: fMRI scans, mapping brain connectivity using EEG in combination with eye-tracking technology (the BNA technology developed by ELMINDA)…
- Trial name
- TBI (NCT02878577)
- Testing
- fMRI
- Where
- Israel
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Brain Concussion
ImPACT Online Clinical Study
The researchers want to find out more about a standalone software application, ImPACT Online and how it relates to other commonly used tests of memory, attention and reaction time.
- Trial name
- NCT02701842
- Testing
- ImPACT Online/Paper Pencil Tests, ImPACT Online
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- ImPACT Applications, Inc.
Traumatic Brain Injury
Exercise and Rehabilitation After Traumatic Brain Injury
The purpose of this study is to examine the effects of exercise on recovery after traumatic brain injury. Investigators will determine if exercise enhances rehabilitation by increasing substances (proteins) that can facilitate…
- Trial name
- NCT03407924
- Testing
- Aerobic Exercise (AER), Rehabilitation
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Centre for Neuro Skills
Traumatic Brain Injury
Advanced MRI Applications for Mild Traumatic Brain Injury - UCSF
This hypothesis-generating feasibility study compares mTBI Patients and Controls using advanced MRI Applications.
- Trial name
- TBI-2 (NCT02141360)
- Testing
- MRI Diagnostic
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- GE Healthcare
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
Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure…
- Trial name
- NCT05951777
- Testing
- Autologous HB-adMSCs, Normal Saline
- Where
- 2 sites in United States
- Volunteers
- 51 people
- Sponsor
- Hope Biosciences LLC
Traumatic Brain Injury
Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device
The aim of this prospective, interventional study is to assess the feasibility and safety of the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the treating physician is treating with…
- Trial name
- NCT02420639
- Testing
- Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.
- Where
- Ukraine
- Volunteers
- 12 people
- Sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical