Clinical trials: Head Trauma Injury
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
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
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
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.
Traumatic Brain Injury
Phase 2 a Study to Assess Safety and Pharmacokinetics of VAS203 in Patients With Traumatic Brain Injury
In the exploratory multi-center Phase 2 a study safety, tolerability, pharmacodynamics and pharmacokinetics of the Nitric Oxide Synthase inhibitor VAS203 is assessed in patients with moderate and severe traumatic brain injury.
- Trial name
- NOSTRA (NCT02012582)
- Testing
- VAS203, Saline
- Where
- 6 sites in Austria, France and 3 more
- Volunteers
- 32 people
- Sponsor
- veriNOS operations GmbH
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.
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
Atrial Fibrillation
Medical Need of OAC Reversal
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF
- Trial name
- NCT03254147
- Testing
- warfarin, dabigatran, Apixaban
- Where
- Japan
- Volunteers
- 53,969 people
- Sponsor
- Boehringer Ingelheim
Chronic Traumatic Encephalopathy
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.
- Trial name
- NCT02079766
- Testing
- florbetapir F 18, Flortaucipir F18
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Avid Radiopharmaceuticals
Traumatic Brain Injury
Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device
The aim of this prospective, interventional study is to assess the feasibility and safety of the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the treating physician is treating with…
- Trial name
- NCT02420639
- Testing
- Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.
- Where
- Ukraine
- Volunteers
- 12 people
- Sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical