Clinical trials: Head Injury Trauma
Cerebrospinal Fluid Leak
Post-market Assessment of Biodesign Dural Repair Grafts
The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.
- Trial name
- NCT04057157
- Testing
- Biodesign Dural or Duraplasty Repair Grafts
- Where
- 3 sites in United States, Canada and 1 more
- Volunteers
- 128 people
- Sponsor
- Cook Research Incorporated
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
Traumatic Brain Injury
The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery
The purpose of this trial is to investigate safety and efficacy of Cerebrolysin as add-on therapy to standard care in patients with acute traumatic brain injury (TBI). The study duration for each patient is 180 days.
- Trial name
- CAPTAIN (NCT01606111)
- Testing
- Cerebrolysin, 0.9% NaCl, saline
- Where
- Hong Kong
- Volunteers
- 46 people
- Sponsor
- Ever Neuro Pharma GmbH
Cerebrospinal Fluid Leak
Suturable DuraGen™ PMCF Study
The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.
- Trial name
- NCT04923867
- Testing
- Suturable DuraGen™
- Where
- 3 sites in United States
- Volunteers
- 106 people
- Sponsor
- Integra LifeSciences Corporation
Neuromuscular Disorders, Neurodevelopmental Disorders
Efficacy and Usability of the EXPLORER Exoskeleton in Children With Neurodevelopmental Disorders in Natural Environments
Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk.
- Trial name
- NCT06765070
- Testing
- EXPLORER
- Where
- 6 sites in Spain
- Volunteers
- 15 people
- Sponsor
- MarsiBionics
Concussion, Brain
Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment, Young Adults and Adults
Concussion is widely recognized as a major public health concern in the United States and worldwide. Although many concussions resolve completely and spontaneously, almost 1 in 4 patients will go on to experience post-concussion…
- Trial name
- NCT03249675
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- ElMindA Ltd
Brain Concussion, Vestibular Disorder
Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI
The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with…
- Conditions
- Brain Concussion, Vestibular Disorder, Cognition Disorder, Mild Traumatic Brain Injury
- Trial name
- Praxis (NCT06314464)
- Testing
- Praxis, Supervised cardiovascular exercise
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- BlueHalo
Traumatic Brain Injury
Normothermia Protocol for Traumatic Brain Injury Patients
Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets) 1. Normothermia Protocol is successful in achieving and maintaining normal temperature in moderate to severe Traumatic Brain Injury…
- Trial name
- NCT01354509
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medivance, Inc.
Cerebral Palsy, Multiple Sclerosis
Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery
The purpose of this study is to record signatures from the fluid surrounding the spinal cord from people who have an implanted drug infusion system.
- Conditions
- Cerebral Palsy, Multiple Sclerosis, Traumatic Brain Injury, Spinal Cord Injury
- Trial name
- NCT01117090
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- MedtronicNeuro
Brain Injuries, Traumatic, Concussion, Brain
Objective Brain Function Assessment of mTBI/Concussion in High School Athletes
This study (Part 2) 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, Brain, Concussion, Mild, Concussion, Intermediate
- Trial name
- AheadCAS-HS (NCT02661633)
- Testing
- BrainScope Ahead 200iD, Advanced MRI Neuroimaging
- Where
- 4 sites in United States
- Volunteers
- 177 people
- Sponsor
- BrainScope Company, Inc.
Mild Traumatic Brain Injury
SSVEP Evaluation of Brain Function (PRO)
The investigational device used in this clinical investigation, the Nurochek PRO System (NCPRO), is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP.
- Trial name
- NCT06013566
- Testing
- SSVEP
- Where
- Australia
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Headsafe MFG
Pain, Pain Syndrome
Long Term 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
- NCT06072001
- Testing
- Adezunap (AP707)
- Where
- Germany
- Volunteers
- 558 people
- Sponsor
- Apurano Pharmaceuticals GmbH
Orthognathic Surgery, Maxillofacial Abnormalities
Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for…
- Conditions
- Orthognathic Surgery, Maxillofacial Abnormalities, Maxilla Fracture
- Trial name
- CMF-ORTHO (NCT05271383)
- Testing
- Orthognathic surgery using Global D's implants.
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Global D
PTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction
Trifecta Research Study
This observational study evaluates the impact of Ibogaine-Magnesium (IM), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), Magnetic e-Resonance Therapy (MeRT), and Physiological Supplementation (PS) on posttraumatic stress disorder…
- Conditions
- PTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction, Brain Injury, Depression - Major Depressive Disorder
- Trial name
- NCT07717866
- Testing
- Magnetic e-Resonance Therapy (MeRT), Ibogaine Hydrochloride with Magnesium Sulfate, 5-methoxy-N,N-dimethyltryptamine
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Axial Therapeutic Research
Pseudobulbar Affect (PBA), Stroke
Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with…
- Conditions
- Pseudobulbar Affect (PBA), Stroke, Dementia, Traumatic Brain Injury (TBI)
- Trial name
- PRISM II (NCT01799941)
- Testing
- Nuedexta (DM 20 mg/Q 10 mg)
- Where
- United States
- Volunteers
- 367 people
- Sponsor
- Avanir Pharmaceuticals
Traumatic Brain Injury
Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI)
This is a Phase 1, multi-center, randomized, double-blind, placebo-controlled, multiple-ascending- dose trial to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of intravenous PNT001 in hospitalized…
- Trial name
- NCT04677829
- Testing
- PNT001, %5 dextrose for infusion
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pinteon Therapeutics, Inc
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
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.
Stroke
"Evaluation Of ALBA® Device for Upper Extremity Motor Function In Adults With Subacute And Chronic Acquired Brain Injury"
As part of the rehabilitation techniques, robotic equipment has been introduced for the rehabilitation of the upper extremity with promising results.
- Trial name
- NCT05824416
- Testing
- Experimental: ALBA, Conventional Therapy
- Where
- Chile
- Volunteers
- 32 people
- Sponsor
- uMov
Traumatic Brain Injury, Intracranial Hemorrhages
Usability Study of CEREBO® - A Novel Non-invasive Intracranial Bleed Detector
Traumatic Brain Injury (TBI) is the leading cause of death and disability across the globe. Time from injury to treatment is the most critical factor that determines the patient's recovery.
- Trial name
- NCT05340114
- Testing
- CEREBO®
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Bioscan Research Pvt. Ltd.