Clinical trials: Head Trauma
Traumatic Brain Injury
Evaluation of Mild TBI in Collegiate Athletes
The purpose of this study is to evaluate blood-based biomarkers before and after sports-induced concussion using neuroimaging and head impact sensor technology.
- Trial name
- AWARE (NCT02189525)
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Banyan Biomarkers, Inc
Tumor, Cerebral Ventricle, Tumor, Cerebellar
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
- Conditions
- Tumor, Cerebral Ventricle, Tumor, Cerebellar, Aneurysm Cerebral, Trauma, Brain
- Trial name
- LYOPLACE (NCT05441618)
- Testing
- Lyoplant®
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Aesculap AG
Spasticity
Continuous Intrathecal Baclofen Infusion for Chronic Spasticity
The purpose of this clinical investigation is to demonstrate product performance of the Prometra Programmable Pump System in the delivery of intrathecal Lioresal® (baclofen) for the management of severe spasticity.
- Trial name
- CIBI (NCT01051128)
- Testing
- Prometra Programmable Implantable Pump System
- Sponsor
- Flowonix Medical
Mild Traumatic Brain Injury
HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma
The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in the diagnosis and prognosis of patients with…
- Trial name
- HeadSMART II (NCT04423198)
- Testing
- Cognitive Assessment, Patient Reported Neurological Outcome Assessments, Blood Draw
- Where
- 11 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- BRAINBox Solutions Inc
Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.
- Conditions
- Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos, Femur Head Necrosis, Femur Neck Fracture
- Trial name
- NCT02062450
- Testing
- Primary surgery with Dual Mobility Cup, Revision surgery with Dual Mobility Cup
- Volunteers
- 379 people
- Sponsor
- Stryker Trauma and Extremities
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.
Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
People having radiation therapy to the head and neck often develop painful mouth problems - mouth sores, dry mouth, mouth pain, trouble eating and drinking, and changes in taste.
- Conditions
- Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation, Stomatitis (Oral Mucositis), Xerostomia Due to Radiotherapy
- Trial name
- OSEM (NCT07885033)
- Testing
- ORAL CARE PRODUCT KIT
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- UNCANCER LLC
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
Primary Osteoarthritis, Post-Traumatic Arthritis
AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
- Conditions
- Primary Osteoarthritis, Post-Traumatic Arthritis, Inflammatory Joint Disease, Femoral Neck Fracture
- Trial name
- NCT03357445
- Testing
- Avantage Reload cup
- Where
- 4 sites in France, Slovenia
- Volunteers
- 500 people
- Sponsor
- Zimmer Biomet
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