Clinical trials: Brain Injuries,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
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
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
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
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.
Brain Edema, TBI (Traumatic Brain Injury)
Dynamic Decompressive Craniotomy
Prospective observational study on patients undergoing decompressive craniotomy
- Conditions
- Brain Edema, TBI (Traumatic Brain Injury), Stroke, Acute, Cerebral Hemorrhage
- Trial name
- NCT05051488
- Testing
- Dynamic craniotomy
- Volunteers
- 20 people
- Sponsor
- Rohit Khanna, MD
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
Brain Injury
Intermediate Size Patient Population Expanded Access Protocol to Evaluate HB-adMSCs for the Treatment of Patients With Traumatic or Nontraumatic Brain Injury
This expanded access protocol is part of IND 031942 to evaluate efficacy and safety of multiple intravenous administrations of allogeneic HB-adMSCs for the treatment of nontraumatic or traumatic brain injury for up to 8 patients…
- Trial name
- NCT07164482
- Testing
- HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells)
- Where
- United States
- Sponsor
- Hope Biosciences Research Foundation
Traumatic Brain Injury, Controls
Traumatic Brain Injury Feasibility Study (EPIC-011)
The purpose of this research study is to evaluate whether data made by the ClearView System can be used to detect whether someone has a traumatic brain injury and how severe the injury is.
- Trial name
- TBI (NCT02471625)
- Testing
- ClearView Scanning
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Epic Research & Diagnostics, Inc.
Pain, Pain Syndrome
Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis
Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates…
- Conditions
- Pain, Pain Syndrome, Pain, Chronic, Chronic Pain
- Trial name
- NCT06071949
- Testing
- Adezunap
- Where
- Germany
- Volunteers
- 558 people
- Sponsor
- Apurano Pharmaceuticals GmbH
Traumatic Brain Injury
Effects of TT301 on Cytokine Levels Post Endotoxin Challenge
This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
- Trial name
- NCT01357421
- Testing
- TT301
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- OPKO Health, Inc.
PTSD
Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD.
- Trial name
- NCT04030169
- Testing
- Midomafetamine HCl
- Where
- 6 sites in Czechia, Germany and 3 more
- Volunteers
- 21 people
- Sponsor
- MAPS Europe B.V.
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.