Clinical trials: Trauma, Head
Cerebrospinal Fluid Leak
The EVICEL® Neurosurgery Phase III Study
The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant (Human) for use as an adjunct to sutured dural repair in cranial surgery.
- Trial name
- NCT02457546
- Testing
- EVICEL Fibrin Sealant, Hydrogel sealant
- Where
- 26 sites in United States, Australia and 4 more
- Volunteers
- 234 people
- Sponsor
- Ethicon, Inc.
Cerebrospinal Fluid Leak
Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery
The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.
- Trial name
- NCT02891070
- Testing
- FS VH S/D 500 s-apr, DuraSeal Dural Sealant
- Where
- 25 sites in United States, Czechia and 2 more
- Volunteers
- 224 people
- Sponsor
- Baxter Healthcare Corporation
Vestibular Diseases, Labyrinth Diseases
Evaluation of a Sensory Enrichment Multimodal Device (SEMD) on Physical Therapy Patients With Disequilibrium
Purpose of this study is to determine the efficiency and safety of a Sensory Enrichment Multimodal Device (SEMD) when applied in conjunction with usual care vestibular-balance physical therapy for rehabilitation of patients who…
- Conditions
- Vestibular Diseases, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases
- Trial name
- SEMD (NCT01483937)
- Testing
- Usual care physical therapy plus SEMD, Usual care physical therapy only
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Karen L Atkins
Spasticity
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity
Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of lower limb spasticity, in adults followed by an open-label extension…
- Trial name
- NCT04099667
- Testing
- Phase 2; Low Dose MYOBLOC (15,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units), Phase 3; MYOBLOC
- Where
- 9 sites in United States, Hungary and 1 more
- Volunteers
- 40 people
- Sponsor
- Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
Chronic Troublesome Sialorrhea, Cerebral Palsy
Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability
The objective of this study is to investigate the efficacy and safety of NT 201 compared with placebo for the treatment of chronic troublesome sialorrhea associated with neurological disorders (e.g.
- Conditions
- Chronic Troublesome Sialorrhea, Cerebral Palsy, Stroke, Traumatic Brain Injury
- Trial name
- SIPEXI (NCT02270736)
- Testing
- NT 201
- Where
- 31 sites in Georgia, Hungary and 4 more
- Volunteers
- 256 people
- Sponsor
- Merz Pharmaceuticals GmbH
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
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 Injuries, Growth Hormone Deficiency
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
- Trial name
- NCT00555009
- Testing
- Genotropin
- Where
- 9 sites in France, Italy and 4 more
- Volunteers
- 10 people
- Sponsor
- Pfizer
Concussion, Traumatic Brain Injury
Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between…
- Trial name
- mTBI-phase2 (NCT02556177)
- Testing
- MRI
- Where
- 7 sites in United States
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
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
Corneal Disease, Corneal Opacity
First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness
Prospective, open label, single arm, First in Human (FIH) clinical study to assess safety and efficacy of the CorNeat Keratoprosthesis, a synthetic cornea, for the treatment of corneal blindness
- Conditions
- Corneal Disease, Corneal Opacity, Corneal Injuries
- Trial name
- NCT04485858
- Testing
- CorNeat KPro
- Where
- 8 sites in United States, Canada and 3 more
- Volunteers
- 10 people
- Sponsor
- CorNeat Vision Ltd.
Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA)
Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System
The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA.
- Conditions
- Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA), Femoral Neck Fractures, Avascular Necrosis of Femoral Head
- Trial name
- OR3O (NCT04941729)
- Testing
- OR3O™ - Dual Mobility System, Conventional
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Smith & Nephew Medical (Shanghai) Ltd
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
TBI (Traumatic Brain Injury)
A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection
The purposes of this study are: 1. To determine the sensitivity and specificity of the Near-Infrared Spectroscopy (NIRS) measurements for identifying intracranial hematomas due to trauma. 2.
- Trial name
- NCT00576147
- Testing
- Infrascanner
- Where
- 4 sites in United States
- Volunteers
- 431 people
- Sponsor
- InfraScan, 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
Brain Contusion
A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion
The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo. The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status, functional…
- Trial name
- ASTRAL (NCT03954041)
- Testing
- BIIB093
- Where
- 63 sites in United States, France and 5 more
- Volunteers
- 92 people
- Sponsor
- Remedy Pharmaceuticals, Inc.
Spasticity, Cerebrovascular Accident
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity
Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of upper limb spasticity in adults followed by an open-label extension…
- Conditions
- Spasticity, Cerebrovascular Accident, Multiple Sclerosis, Traumatic Brain Injury
- Trial name
- NCT04815967
- Testing
- Phase 2; Low Dose MYOBLOC (10,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units), Phase 3; MYOBLOC
- Where
- 9 sites in United States, Hungary and 1 more
- Volunteers
- 32 people
- Sponsor
- Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
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, Alexithymia
The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury
The purpose of this study is to examine a web-based training program for treating emotional problems in people who have suffered a traumatic brain injury (TBI).
- Trial name
- NCT02432300
- Testing
- Emotion Builder
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- EmotEd
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.