Clinical trials: Non-traumatic Brain Injury
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
Brain Injuries, Traumatic, Concussion, Mild
Objective Brain Function Assessment of mTBI/Concussion
This study (Part 3) 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, Mild, Concussion, Intermediate, Concussion, Severe
- Trial name
- CAS13-25 (NCT03963804)
- Testing
- BrainScope Ahead 300iP
- Where
- 4 sites in United States
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- BrainScope Company, Inc.
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
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.
PTSD, Post Traumatic Stress Disorder PTSD
Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD)
The goal of this clinical trial is to evaluate the safety and effectiveness of the gammaCore non-invasive vagus nerve stimulation (nVNS) device as an additional treatment for symptoms of post-traumatic stress disorder (PTSD) in…
- Conditions
- PTSD, Post Traumatic Stress Disorder PTSD, PTSD - Post Traumatic Stress Disorder, Post Traumatic Stress Disorder
- Trial name
- NCT07523685
- Testing
- non-invasive vagus nerve stimulation
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Acacia Clinics
Neurobehavioral Disinhibition
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury…
- Trial name
- NCT03095066
- Testing
- AVP-786-28, AVP-786-42.63
- Where
- 54 sites in United States
- Volunteers
- 168 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, 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
Brain Concussion
Mild Traumatic Brain Injury Discrimination
Evaluation of the utility of a multi-modal assessment tool in distinguishing between individuals with and without a history of mild traumatic brain injury.
- Trial name
- MTBID (NCT02453958)
- Testing
- Multi-modal assessment system
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Empirical Technologies Corporation
Brain Concussion
Control Study of Nautilus BrainPulse for the Detection of Concussion
To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's signal patterns with those of concussed high school athletes.
- Trial name
- NCT02350699
- Testing
- Nautilus BrainPulse
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Jan Medical, Inc.
Brain Concussion, Mild Traumatic Brain Injury
Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)
The multi-center study evaluates BrainPulse recordings from subjects with a suspected or confirmed concussion to improve a concussion detection algorithm.
- Trial name
- NCT02812225
- Testing
- BrainPulse
- Where
- 3 sites in United States
- Volunteers
- 406 people
- Sponsor
- Jan Medical, Inc.
Intracranial Hypertension
Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients
The purpose of this study is to prospectively evaluate the accuracy and safety of non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000) device compared to the current invasive external…
- Trial name
- NCT02695264
- Testing
- HS-1000 recording
- Where
- United States
- Sponsor
- HeadSense Medical
Traumatic Brain Injury
A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy
This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury…
- Trial name
- NCT04063215
- Testing
- HB-adMSCs
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Hope Biosciences LLC
Traumatic Brain Injury
A Study to Evaluate the SENSE Device's Ability to Detect TBI
The study population will consist of 3 mutually-exclusive sets of patients and subjects: TBI patients with intracranial bleeding TBI patients without intracranial bleeding Control subjects with normal brain health.
- Trial name
- SENSE-007 (NCT06828107)
- Testing
- SENSE device
- Where
- 6 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Sense Diagnostics, LLC
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.
Intracranial Pressure, Intracranial Pressure Changes
CoMind Early Feasibility Study
The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around…
- Conditions
- Intracranial Pressure, Intracranial Pressure Changes, Traumatic Brain Injury, Intracerebral Hemorrhage
- Trial name
- CoMind EFS (NCT06368648)
- Where
- 17 sites in United States
- Volunteers
- 581 people
- Sponsor
- CoMind Technologies Limited
Traumatic Brain Injury, Intracranial Hypertension
A Non-invasive Intracranial Pressure (nICP) Monitoring System
Researchers have developed a probe that contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe.
- Trial name
- NCT05632302
- Testing
- nICP
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Crainio Ltda
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
Brain Injuries, Traumatic
Biomarkers of Traumatic Brain Injury With Tbit System
A prospective, multi-center, non-randomized, pivotal study to assess the safety and efficacy of the Tbit™ System to aid in patient evaluation, suspected of traumatic brain injury, as adjunct companion test to radiologic standard…
- Trial name
- NCT04107662
- Testing
- Tbit system
- Volunteers
- 740 people
- Sponsor
- BioDirection Inc
Concussion
Concussion Testing: A Novel Non-invasive Concussion Detection Device
The purpose of this study is to establish and evaluate a distinctive signal for concussion.
- Trial name
- NCT02370914
- Testing
- Nautilus NeuroWaveTM System, SCAT
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Jan Medical, Inc.