Clinical trials: Injury Traumatic
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.
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
Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System
The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify that both UCH-L1 and GFAP can be detected…
- Trial name
- FIRST DOWN (NCT03060109)
- Testing
- Blood draw within 12 hours of injury
- Where
- 4 sites in Netherlands
- Volunteers
- 317 people
- Sponsor
- Banyan Biomarkers, Inc
Brain Injuries
Study of NNZ-2566 in Patients With Traumatic Brain Injury Under EFIC
The purpose of this study is to determine whether NNZ-2566 is safe and effective in the treatment of Traumatic Brain Injury (TBI).
- Trial name
- INTREPID2566 (NCT01366820)
- Testing
- NNZ-2566
- Where
- 6 sites in United States
- Volunteers
- 261 people
- Sponsor
- Neuren Pharmaceuticals Limited
Iatrogenic Vessel Injury
Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries
The purpose of this study is to confirm device efficacy and safety of the GORE® VIABAHN® Endoprosthesis (hereafter "VB device") for the treatment of traumatic or iatrogenic vessel injury in thoracic, abdominal, and pelvic…
- Trial name
- NCT05183399
- Testing
- GORE® VIABAHN® Endoprosthesis
- Volunteers
- 30 people
- Sponsor
- W.L.Gore & Associates
Emotional Dysregulation, Therapeutic Alliance
Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth
Emotional dysregulation in justice-involved youth (JIY) is a condition that significantly impacts young people, their families, and juvenile justice and public health systems.
- Conditions
- Emotional Dysregulation, Therapeutic Alliance, Depression Disorder, Anxiety Disorders
- Trial name
- HEAL-SLOJSC (NCT07364799)
- Testing
- Multi-sensory emotional regulation intervention (Heal)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- SoundHeal
Post-Traumatic Stress Disorder, Stress Disorders, Post-Traumatic
Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)
This is a single-blind, placebo-controlled, parallel group study to evaluate the efficacy of BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily…
- Trial name
- NCT00557622
- Testing
- paroxetine
- Where
- 9 sites in Japan
- Volunteers
- 5 people
- Sponsor
- GlaxoSmithKline
Post-Traumatic Stress Disorder, PTSD
Software as a Medical Device for the Treatment of Patients With PTSD
To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)
- Trial name
- NCT06589505
- Testing
- Software as a Medical Device
- Where
- 35 sites in Japan
- Volunteers
- 52 people
- Sponsor
- Otsuka Medical Devices Co., Ltd. Japan
Mild Traumatic Brain Injury, Intracranial Lesions
TES HT100 Clinical Validation for Brain Injury Screening in Patients With Mild Head Trauma or Neurological Symptoms
The goal of this clinical study is to evaluate how accurately and safely the TES HT100 device can identify intracranial abnormalities in adult emergency department patients with mild head trauma or neurological symptoms that are…
- Conditions
- Mild Traumatic Brain Injury, Intracranial Lesions, Neurological Symptoms Not Related to Head Trauma
- Trial name
- TESCO (NCT07490418)
- Testing
- Temnographic Brain Screening Examination
- Where
- 3 sites in Italy, Poland
- Volunteers
- 850 people
- Sponsor
- B&B srl
Brain Concussion, Brain Injuries
An Evaluation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion
The HeadSense (HS) HS-1000 device, a new non-invasive brain monitor is expected to safely and accurately monitor concussed patients with minimal discomfort, potentially providing a new modality for concussion measurement.
- Trial name
- NCT02699346
- Testing
- HS-1000 recording
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- HeadSense Medical
Subdural Hematoma, Subdural Hematoma, Chronic
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.
- Trial name
- HARMONY (NCT07258069)
- Testing
- Histoacryl®
- Where
- 6 sites in Japan
- Volunteers
- 178 people
- Sponsor
- Aesculap AG
Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices.
- Conditions
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures
- Trial name
- NCT05227924
- Testing
- Total hip arthroplasty (primary or revision)
- Where
- 9 sites in France
- Volunteers
- 747 people
- Sponsor
- Dedienne Sante S.A.S.
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
Post Traumatic Stress Disorder
Effectiveness of Sana Treatment in Post-Traumatic Stress Disorder (PTSD)
The purpose of this study is to assess the effectiveness of the Sana Device when added to Treatment as Usual in participants with a diagnosis of post-traumatic stress disorder (PTSD)
- Trial name
- NCT05319405
- Testing
- Sana Device
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Sana Health
PTSD, Post Traumatic Stress Disorder
Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
- Trial name
- NCT06868446
- Testing
- OTX-601 Digital Therapeutic - Version 1, OTX-601 Digital Therapeutic - Version 2, Treatment as Usual (TAU)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Oui Therapeutics, Inc.
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.
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
Erectile Dysfunction, Spinal Cord Injury
Assess Efficacy in Subjects With Traumatic Spinal Cord Injury
Assess efficacy of Vardenafil in patients with traumatic spinal cord injury
- Trial name
- LEMDE (NCT00667966)
- Testing
- Vardenafil (Levitra, BAY 38-9456), 10 mg, Vardenafil (Levitra, BAY 38-9456), 20 mg
- Where
- 2 sites in Spain
- Volunteers
- 45 people
- Sponsor
- Bayer
Brain Injuries, Craniocerebral Trauma
Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury
The purpose of the current study is proposed to prospectively assess how accurately the BrainScope® Ahead™ M-100 can distinguish risk categories for acute head injury.
- Trial name
- NCT01430988
- Where
- 3 sites in United Kingdom
- Volunteers
- 318 people
- Sponsor
- BrainScope Company, Inc.
Brain Injuries, Craniocerebral Trauma
Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology
The objectives of the study are to document device performance with respect to the primary and secondary endpoints.
- Trial name
- B-AHEAD II (NCT01556711)
- Where
- 11 sites in United States
- Volunteers
- 816 people
- Sponsor
- BrainScope Company, Inc.