Clinical trials: Brain Injuries,Traumatic
Mild Traumatic Brain Injury, Concussion
A Randomised, Double-blind, Placebo-controlled Phase 2a Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONP-002 in Adults With Mild Traumatic Brain Injury
This is a Phase IIa, randomized, double-blind, placebo-controlled pilot study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ONP-002 in adults with mild traumatic brain injury (mTBI).
- Trial name
- NCT06870240
- Testing
- Neurosteroid enantiomer
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- Oragenics, Inc.
Alzheimer's Disease, Amyotrophic Lateral Sclerosis (ALS)
PRISM Registry: Pseudobulbar Affect Registry Series
PBA is a neurologic condition that is estimated to impact over a million patients and their families in the United States. PBA occurs secondary to an otherwise unrelated neurologic disease or injury, and manifests as involuntary…
- Conditions
- Alzheimer's Disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease
- Trial name
- NCT01366027
- Where
- United States
- Volunteers
- 5,290 people
- Sponsor
- Avanir Pharmaceuticals
Traumatic Brain Injury (TBI), Acquired Brain Injury
LearningRx Cognitive Training for Brain Injury
The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, daily functioning, and workplace self-efficacy for participants with Traumatic Brain…
- Conditions
- Traumatic Brain Injury (TBI), Acquired Brain Injury, Post COVID-19 Cognitive Impairment
- Trial name
- NCT02918994
- Testing
- LearningRx cognitive training
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Gibson Institute of Cognitive Research
Traumatic Subdural Hematoma
Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly
Acute traumatic subdural hematomas (TSDH) readmission rate is high (27.8%) with an increase in morbidity and cost for the elderly.
- Trial name
- NCT03878043
- Testing
- Follow-up Care
- Where
- United States
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- Tarik Wasfie, MD
TBI (Traumatic Brain Injury), Concussion, Brain
Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One
The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC)…
- Conditions
- TBI (Traumatic Brain Injury), Concussion, Brain, MTBI - Mild Traumatic Brain Injury, Closed Head Injury
- Trial name
- MEDO (NCT04279431)
- Testing
- EEG Recording, Neurocognitive Tests, Clinician Evaluation
- Where
- 7 sites in United States
- Volunteers
- 660 people
- Sponsor
- BrainScope Company, Inc.
PTSD, Alzheimer Disease
First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)
The goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are: What is the safety of single ascending doses of the…
- Conditions
- PTSD, Alzheimer Disease, Brain Diseases, Neuro-Degenerative Disease
- Trial name
- NCT05921929
- Testing
- Fluoroethylnormemantine (FENM)
- Where
- Belgium
- Volunteers
- healthy volunteers welcome
- Sponsor
- ReST Therapeutics
Subdural Hematoma
Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma…
- Trial name
- EMBOLISE (NCT04402632)
- Testing
- Surgical Management, Onyx™ Liquid Embolic System (LES) Embolization, Observation Only
- Where
- 49 sites in United States
- Volunteers
- 600 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
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 Injuries
Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.
- Trial name
- SyNAPSe (NCT01143064)
- Testing
- Progesterone, Lipid emulsion without progesterone
- Where
- 156 sites in United States, Argentina and 19 more
- Volunteers
- 1,195 people
- Sponsor
- BHR Pharma, LLC
Acquired Bleeding Disorder, Trauma
Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury
This study is conducted in North America. The purpose of this study is to evaluate the occurrence and severity of bleeding in brain injury and to identify important safety issues following traumatic brain injury.
- Trial name
- NCT00124293
- Testing
- activated recombinant human factor VII
- Where
- 2 sites in United States, Canada
- Volunteers
- 63 people
- Sponsor
- Novo Nordisk A/S
Brain Injury
MIND (Management of Traumatic Brain Injury Diagnosis)
Procure blood specimens from individuals presenting to the emergency department with suspected brain injury.
- Trial name
- MIND (NCT02262286)
- Where
- Germany
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Abbott Diagnostics Division
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
Chronic Subdural Hematoma
Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas…
- Trial name
- MEMBRANE (NCT04816591)
- Testing
- Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System, Standard of Care Surgery, Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System
- Where
- 33 sites in United States, China
- Volunteers
- 376 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Brain Concussion, Brain Injuries
Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
The HS-1000 is an innovative non-invasive monitoring device that employs advanced acoustic signal analysis to calculate ICP on a continuous basis.
- Trial name
- NCT02699359
- Testing
- HS-1000 recording
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- HeadSense Medical
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
Cardiovascular Diseases, Cancer
Phase I Human Analytics (HALO) Study
Discover, optimize, standardize, and validate clinical-trial measures and biomarkers used to diagnose and differentiate cardiovascular, oncologic, neurologic, and other diseases and disorders.
- Conditions
- Cardiovascular Diseases, Cancer, Dementia, Traumatic Brain Injury
- Trial name
- HALO (NCT05423860)
- Testing
- no interventions will be performed (observational)
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- HALO Diagnostics
Traumatic Brain Injury
Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
- Trial name
- NCT00893789
- Testing
- Armodafinil
- Where
- 73 sites in United States, Germany and 2 more
- Volunteers
- 117 people
- Sponsor
- Cephalon, Inc.
Brain Injury, Chronic, Brain Injuries, Traumatic
Traumatic Brain Injury and the Gut Microbiome
The purpose of the study is to determine whether administration of a prebiotic, inulin, can improve the symptom complex associated with traumatic brain injury and whether inulin administration can alter the bacteria that live in…
- Trial name
- NCT04949607
- Testing
- Inulin fructooligosaccharide
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Centre for Neuro Skills
Concussion
A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion
The objective of the study is to evaluate, in a blinded fashion, the effectiveness of the Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.
- Trial name
- NCT02660164
- Testing
- Nautilus BrainPulse Recording
- Where
- 4 sites in United States
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Jan Medical, Inc.
Traumatic Brain Injury, Chronic Balance Disorder
Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)
The purpose of this study is to determine if clinic and home training with a study device will improve a balance deficit. The study device is called Portable Neuromodulation Stimulator (PoNS).
- Trial name
- NCT02429167
- Testing
- Cranial nerve non-invasive neuromodulation via PoNS device
- Where
- 3 sites in United States, Canada
- Volunteers
- 122 people
- Sponsor
- Helius Medical Inc