Clinical trials: Craniocerebral Trauma
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
Head Trauma,Closed
International Trial of Efficacy of Cytoflavin in Head Trauma
The study will access the efficacy and safety of treatment with CITOFLAVIN® in patients with non-penetrating moderately severe traumatic brain injury (TBI).
- Trial name
- MITRA (NCT04631484)
- Testing
- Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid)
- Where
- 8 sites in Kazakhstan, Russia
- Volunteers
- 166 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
Craniocerebral Injury
Study on Clinical Effectiveness of L-Oxiracetam Injection
A randomized, double-blind, positive drug/placebo parallel controlled, multicenter, phase III clinical trial of L-oxiracetam injection to improve memory and cognitive Impairment in patients with craniocerebral injury.
- Trial name
- NCT04205565
- Testing
- Test group: L-oxiracetam Injection, Control group: Oxiracetam Injection
- Where
- China
- Volunteers
- 591 people
- Sponsor
- Nanjing Yoko Biomedical Co., Ltd.
Traumatic Brain Injury
Evaluation of Biomarkers of Traumatic Brain Injury
The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma Scale score 9-15) in conjunction with other…
- Trial name
- ALERT-TBI (NCT01426919)
- Testing
- Head CT scan and blood draw within 12 hours of injury
- Where
- 24 sites in United States, Germany and 1 more
- Volunteers
- 2,011 people
- Sponsor
- Banyan Biomarkers, Inc
Traumatic Brain Injury
Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma
The primary objective of the clinical trial is to evaluate the effect of time on levels of Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of head injured…
- Trial name
- VIGILANT (NCT02541123)
- Testing
- Blood draw
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 194 people
- Sponsor
- Banyan Biomarkers, Inc
Head Injury, Intracranial Pathology
Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion (4hour)
The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation.
- Conditions
- Head Injury, Intracranial Pathology, Compromised Cerebral Perfusion
- Trial name
- NCT02388880
- Testing
- ITPR
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Advanced Circulatory Systems
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.
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
Head Injury, Intracranial Pathology
Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion
The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation.
- Conditions
- Head Injury, Intracranial Pathology, Compromised Cerebral Perfusion
- Trial name
- NCT01824576
- Testing
- ITPR
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Advanced Circulatory Systems
Traumatic Brain Injury
EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY
The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive subjects (as determined by an independent…
- Trial name
- ALERT-TBIx (NCT02439736)
- Testing
- Blood draw within 12 hours of head injury
- Where
- 7 sites in United States, Germany
- Volunteers
- 119 people
- Sponsor
- Banyan Biomarkers, Inc
Traumatic Brain Injury, Sports Concussion
A Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes
The purpose of this study is to study the biomarkers in subjects before and after sports-induced traumatic brain injury. The assay will be studied in a sample population of subjects over the age of 18 participating in college…
- Conditions
- Traumatic Brain Injury, Sports Concussion, Sports Injury
- Trial name
- GATOR (NCT01472042)
- Testing
- Banyan Biomarkers
- Where
- United States
- Volunteers
- 265 people, healthy volunteers welcome
- Sponsor
- Banyan Biomarkers, 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
Cerebral Hemorrhage, Head Injury
Biomarkers Correlation With Volemia
The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7…
- Conditions
- Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery, Poly Trauma Patients Without Heart Failure
- Trial name
- ENVOL (NCT01858675)
- Testing
- Biomarkers, red blood cells and plasma assessment
- Where
- France
- Volunteers
- 66 people
- Sponsor
- ThermoFisher Scientific Brahms Biomarkers France
Traumatic Subarachnoid Haemorrhage
Neurological Outcome in Patients of Traumatic Subarachnoid Haemorrhage
Traumatic brain injury is common cause of morbidity and mortality worldwide. Incidence and pattern of traumatic brain injury varies in developed and developing countries.
- Trial name
- NCT02073890
- Volunteers
- 117 people
- Sponsor
- Macmillan Research Group UK
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 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.
Traumatic Brain Injury With Persistent Cognitive Deficits
An Extension Study Evaluating the Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits
Patients who completed the 12-week double blind protocol may enter this 26-week, open-label extension. This extension will give patients who complete the study an opportunity to receive treatment with open-label rivastigmine 3-12…
- Trial name
- NCT00219245
- Testing
- Rivastigmine
- Volunteers
- 157 people
- Sponsor
- Novartis
Severe Head Trauma
Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8).
- Trial name
- ABELADRUG200 (NCT00810940)
- Testing
- AbelaDrug200, mannitol
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Abela Pharmaceuticals, Inc.
Stroke, Craniocerebral Trauma
Pilot Study Assessing the Feasibility of Treating Foot Drop With the Neurostep™ System.
This pilot feasibility study is assessing the safety and technical performance of the Neurostep™ System for the restoration of independent gait in subjects with gait disorder (i.e. foot drop) secondary to a CNS lesion (e.g.
- Trial name
- NCT00860210
- Testing
- Neurostep™ System
- Where
- 4 sites in Canada, India and 1 more
- Volunteers
- 14 people
- Sponsor
- Neurostream Technologies G.P.