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24 result(s) found

Brain Contusion


A Multicenter, Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients with Brain Contusion.

The primary objective of this study is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo. Secondary objectives and endpoints for the study are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.

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Brain Tumors


A Phase III Trial Of Stereotactic Radiosurgery Compared With Whole Brain Radiotherapy (WBRT) For 5-15 Brain Metastases

This is an international multi-centre, open-label, randomized phase III trial comparing stereotactic radiosurgery (SRS) to whole brain radiotherapy (WBRT) in patients with 5 to 15 brain metastases.

Primary Objectives

• To compare the overall survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive WBRT.

• To compare the neurocognitive progression-free survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive WBRT.

 

Secondary Objectives

Patient/treatment Related Secondary Outcomes

• To compare time to central nervous system (CNS) failure (local, distant, and leptomeningeal) in patients who receive SRS compared to patients who receive WBRT.

• To evaluate if there is any difference in CNS failure patterns (local, distant, or leptomeningeal) in patients who receive SRS compared to patients who receive WBRT.

• To evaluate number of salvage procedures following SRS in comparison to WBRT.

• To evaluate the individual cognitive test results following SRS in comparison to WBRT.

• To tabulate and descriptively compare the post-treatment adverse events associated with the interventions.

• To evaluate the time delay to (re-)initiation of systemic therapy in patients receiving SRS in comparison to WBRT.

• To prospectively validate a predictive nomogram for distant brain failure [Ayala-Peacock 2014].

Economic Endpoints

• To compare the estimated cost of brain-related therapies in patients who receive SRS compared to patients who receive WBRT:

- Comparison based on payer rates (Medicare for US / provincial heath authorities in Canadian jurisdictions with activity-based funding).

Quality of Life Endpoints

• To evaluate patient’s quality of life, as assessed by the EORTC QLQ-C30 + BN20, EQ-5D, ECOG performance status, for those who receive SRS compared to those who receive WBRT.

Translational Endpoints

• Collect plasma to evaluate whether detectable somatic mutations in liquid biopsy can enhance prediction of the overall survival and development of new brain metastases.

• Analysis of serum samples for inflammatory biomarker C-reactive protein and brain-derived-neurotrophic factor (BDNF) to elucidate molecular/genomic mechanisms of neurocognitive decline and associated radiographic changes.

Imaging/Dosimetric Endpoints

• Collect whole-brain dosimetry in SRS patients to be prospectively correlated with cognitive toxicity, intracranial control and radiation necrosis (hippocampal dosimetry will be retrospectively assessed).

• Collect imaging parameters and workflow details relating to the radiosurgery planning MRIs (including timing of MR prior to radiosurgery, magnet field strength, contrast type/dose/timing, use of image post-processing, and formal reviewed by radiology) to be prospectively correlated with tumour control outcomes (local control, intracranial control).

• Evaluate serial changes in imaging features found in routine MRI images (T2w changes, morphometry) that may predict tumour control and/or neurocognitive outcomes

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Breast Cancer


A Phase III Trial Of Stereotactic Radiosurgery Compared With Whole Brain Radiotherapy (WBRT) For 5-15 Brain Metastases

This is an international multi-centre, open-label, randomized phase III trial comparing stereotactic radiosurgery (SRS) to whole brain radiotherapy (WBRT) in patients with 5 to 15 brain metastases.

Primary Objectives

• To compare the overall survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive WBRT.

• To compare the neurocognitive progression-free survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive WBRT.

 

Secondary Objectives

Patient/treatment Related Secondary Outcomes

• To compare time to central nervous system (CNS) failure (local, distant, and leptomeningeal) in patients who receive SRS compared to patients who receive WBRT.

• To evaluate if there is any difference in CNS failure patterns (local, distant, or leptomeningeal) in patients who receive SRS compared to patients who receive WBRT.

• To evaluate number of salvage procedures following SRS in comparison to WBRT.

• To evaluate the individual cognitive test results following SRS in comparison to WBRT.

• To tabulate and descriptively compare the post-treatment adverse events associated with the interventions.

• To evaluate the time delay to (re-)initiation of systemic therapy in patients receiving SRS in comparison to WBRT.

• To prospectively validate a predictive nomogram for distant brain failure [Ayala-Peacock 2014].

Economic Endpoints

• To compare the estimated cost of brain-related therapies in patients who receive SRS compared to patients who receive WBRT:

- Comparison based on payer rates (Medicare for US / provincial heath authorities in Canadian jurisdictions with activity-based funding).

Quality of Life Endpoints

• To evaluate patient’s quality of life, as assessed by the EORTC QLQ-C30 + BN20, EQ-5D, ECOG performance status, for those who receive SRS compared to those who receive WBRT.

Translational Endpoints

• Collect plasma to evaluate whether detectable somatic mutations in liquid biopsy can enhance prediction of the overall survival and development of new brain metastases.

• Analysis of serum samples for inflammatory biomarker C-reactive protein and brain-derived-neurotrophic factor (BDNF) to elucidate molecular/genomic mechanisms of neurocognitive decline and associated radiographic changes.

Imaging/Dosimetric Endpoints

• Collect whole-brain dosimetry in SRS patients to be prospectively correlated with cognitive toxicity, intracranial control and radiation necrosis (hippocampal dosimetry will be retrospectively assessed).

• Collect imaging parameters and workflow details relating to the radiosurgery planning MRIs (including timing of MR prior to radiosurgery, magnet field strength, contrast type/dose/timing, use of image post-processing, and formal reviewed by radiology) to be prospectively correlated with tumour control outcomes (local control, intracranial control).

• Evaluate serial changes in imaging features found in routine MRI images (T2w changes, morphometry) that may predict tumour control and/or neurocognitive outcomes

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Epilepsy


A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Exploring the Efficacy, Safety, and Tolerability of Natalizumab (BG00002) as Adjunctive Therapy in Adult Subjects With Drug-Resistant Focal Epilepsy

This is a 6-month randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of natalizumab as adjunctive therapy in the treatment of adult subjects with drug-resistant focal epilepsy. The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency. 

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Healthy Volunteers


Objective Portable Diagnostics of Neurological Disorders using Visual Evoked Potentials

This study focuses on developing a new portable noninvasive system to aid in the diagnosis of the vision disorders Multiple Sclerosis and Optic Neuritis. This device combines images and patterns using a Head Mounted Display, similar to a virtual reality headset. The system measures brain responses to these images using a form of electroencephalography (EEG), which will give us information about how the brain and eyes communicate and how this may be affected by a vision disorder.

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Intracerebral Hemorrhage


Statins Use In Intracerebral Hemorrhage Patients

SATURN is a multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE) clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation of statin therapy (using the same agent and dose that they were using at ICH onset). Participating subjects will undergo baseline testing for APOE genotype and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or major adverse cerebro-/cardio-vascular events (MACCE) during the follow-up period.

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Intracranial Pressure


A pilot study to assess non-invasive near-infrared spectroscopy measurements of Coherent Hemodynamics Spectroscopy for the assessment of cerebral autoregulation and blood flow

This study is being done to find out if an external and painless method of measuring and monitoring the health of blood vessels within the head and the blood that flows in them is possible. This may be useful to clinicians as changes in cerebral blood flow are a frequent complication of neurological and neurosurgical disease and frequently need to be treated and monitored. Our goal is to show that this simple external monitor can improve the information that standard monitors provide, including surgically-implanted monitors. The way in which intracranial pressure (ICP) is monitored is by using a catheter inserted through the skull into the brain though a small incision made under local anesthesia at the bedside in the Intensive Care Unit (ICU) where you are staying. In contrast, our method of monitoring uses a small optical probe taped temporarily to the skin of your forehead. By comparing the data we will get from this study monitor to the standard monitors you already have, we hope to prove that this technology can be used to replace invasive procedures for these measurements.

The Near Infrared Spectroscopy (NIRS) device which will be taped to your forehead (ISS OxiplexTS), uses low energy light to measure oxygen levels in your blood.  It is similar to the probe that is placed on your finger to measure your oxygen levels.  The ISS OxiplexTX has been approved by the FDA to obtain NIRS measurements, but it has not been used in this way before.

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Prospective evaluation of non-invasive intracranial pressure monitoring

Patients who are admitted to the Tufts Medical Center ICU or PICU and are deemed to require placement of an intracranial pressure (ICP) monitor will be asked to enroll in our study. Patients agreeing will undergo the routine placement of an ICP monitor followed by placement of the study device; a non-invasive extracranial device (I PASS - Intracranial Pressure Assessment and Screening System, Vivonics, INC) containing near infrared probes placed on the ear, forehead and finger. The data will be recorded from IPASS as the routine ICP is recorded. Patients vital signs including heart rate, blood pressure, and SpO2 will also be routinely recorded. Once the patient is felt to no longer require the ICP monitor and it is removed, the IPASS device will also be removed.

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Low Blood Pressure


A clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of droxidopa therapy

This is a 36 week. multi-site, placebo-controlled, double-blind, randomized withdrawal, time to intervention of droxidopa study in adult patients with symptomatic NOH associated with primary autonomic failure including Parkinson’s Disease (PD), Multiple System Atrophy (MSA), or Pre Autonomic Failure (PAF), or Non-diabetic autonomic Neuropathy (NDAN) or dopamine beta hydroxylase (NBH) deficiency. The primary objective is to evaluate the time to treatment intervention.  The secondary objective is to determine the long-term efficacy of droxidopa in this patient population. 

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Multiple Sclerosis


Exploring the safety and tolerability of conversion from oral or injectable disease modifying therapies to dosetitrated Oral Siponimod in patients with advancing forms of relapsing multiple sclerosis: A 6-month open label, multicenter Phase IIIb study (EXCHANGE)

The purpose of this study is to assess early phase safety and tolerability of transitioning patients from approved oral and injectable RMS DMTs to siponimod. The results of this study will guide clinically relevant decisions related to the transition from frequently used RMS DMTs to siponimod and provide clinically relevant data on safety and tolerability for healthcare providers who are considering transitioning patients from currently approved RMS DMT to siponimod. The primary objective is to evaluate overall safety and tolerability profile of siponimod in advancing RMS patients (including a broader population that had not been previously studied with siponimod who are converting from currently approved oral or injectable RMS DMT).

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Objective Portable Diagnostics of Neurological Disorders using Visual Evoked Potentials

This study focuses on developing a new portable noninvasive system to aid in the diagnosis of the vision disorders Multiple Sclerosis and Optic Neuritis. This device combines images and patterns using a Head Mounted Display, similar to a virtual reality headset. The system measures brain responses to these images using a form of electroencephalography (EEG), which will give us information about how the brain and eyes communicate and how this may be affected by a vision disorder.

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Myasthenia Gravis


A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis

This is a phase 3, randomized, double-blind, placebo-controlled, multicenter study that evaluates using ravulizumab infusions as treatment for patients with generalized Myasthenia Gravis. Participants will receive either ravulizumab for the duration of the study or placebo during the 26-week randomized-controlled period of the stufy and then enter the open-label extension period where they will receive ravulizumab. The main outcome will look at the change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at week 26 (end of randomized period).

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Neurogenic Orthostatic Hypotension


A clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of droxidopa therapy

This is a 36 week. multi-site, placebo-controlled, double-blind, randomized withdrawal, time to intervention of droxidopa study in adult patients with symptomatic NOH associated with primary autonomic failure including Parkinson’s Disease (PD), Multiple System Atrophy (MSA), or Pre Autonomic Failure (PAF), or Non-diabetic autonomic Neuropathy (NDAN) or dopamine beta hydroxylase (NBH) deficiency. The primary objective is to evaluate the time to treatment intervention.  The secondary objective is to determine the long-term efficacy of droxidopa in this patient population. 

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Neurologic Diseases


Developing an activity-dependent marker of upper motor neuron dysfunction in motor neuron disorders.

This study is evaluating the potential to use transcranial magnetic stimulation in diagnosis of diagnosis of neurologic conditions that effect movement. We are seeking healthy volunteers and participants with a neurologic condition that affects the ability to move parts of your body.

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Neuromuscular Disorders


Ulnar neuropathy at the the elbow: protective role of the Martin Gruber anastomosis

The purpose of this study is to understand why some patients with nerve entrapment at the elbow do better than others. This study is investigational because it attempts to address the problem comprehensively, using different techniques, something that is not usually done for routine diagnostic purposes.

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Optic Neuritis


Objective Portable Diagnostics of Neurological Disorders using Visual Evoked Potentials

This study focuses on developing a new portable noninvasive system to aid in the diagnosis of the vision disorders Multiple Sclerosis and Optic Neuritis. This device combines images and patterns using a Head Mounted Display, similar to a virtual reality headset. The system measures brain responses to these images using a form of electroencephalography (EEG), which will give us information about how the brain and eyes communicate and how this may be affected by a vision disorder.

More

Parkinson's Disease


A Randomized, Placebo Surgery Controlled, Double-blinded, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Advanced Parkinson’s Disease with Motor Fluctuations

The main purpose of this study is to test the safety and efficacy (how well it works) of an investigational product called VY-AADC02 on the severity of PD. VY-AADC02 involves placing a gene in the brain that programs brain cells to produce an enzyme (protein) called AADC (aromatic amino acid decarboxylase).

Genes are what make up our genetic code, aka DNA – the chemical structure carrying all the information that determines many human traits and characteristics such as the color of your eyes or hair. Each gene can be read by your cells (the building blocks of the human body) as a set of instructions to make a specific protein.

AADC is a naturally occurring protein found in the brain that converts levodopa (one of your current PD medications) to dopamine. Dopamine is a chemical “messenger” that allows the brain cells to communicate with each other and is involved with the normal function of movement control centers in the brain. As PD worsens, the amount of AADC in the brain decreases, and, in turn, this decrease reduces the amount of dopamine that is produced from each dose of levodopa that you take.

In order to deliver the AADC gene into the brain cells, the gene is delivered inside a transporter called adeno-associated viral vector (AAV). To explain this, think about the AADC gene like a letter that carries the information that the brain will read. The AAV acts as the envelope that contains this information, and the combined AADC and AAV can be thought of as the complete package (the letter and envelope that the brain will receive). AAV is used because it is not known to cause disease or spread to others. The combined package of AADC and AAV will be referred to as the “study product” in the remainder of this document. The study product will tell the brain cells to make more AADC, which may increase dopamine levels in your brain when you take levodopa. An increase in dopamine levels may provide improvement in the movement areas in the brain and may help with your PD symptoms.

The investigators hope to learn more about the delivery and distribution of the study product, including the delivery device used in the surgery (called a cannula), the imaging substance (gadolinium) used to visualize the infusion of the study product during the surgery, and how the body reacts to the study product over time using PET (positron emission tomography) scans to determine the change in the level of the AADC gene in your brain. Gadolinium is routinely used for the purpose of imaging, in this study it is considered experimental as it is infused directly into the tissue of the brain, and not through a vein.

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Stroke


A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Add-On to Standard-of-Care Study of n-Butylphthalide (NBP) Softgel Capsules for Treatment of Mild to Moderate Acute Ischemic Stroke in Adult Subjects

The main purpose of this study is to learn the how safe the study drug, n-butylphthalide (NBP) is when added to your routine care. Other purposes of the study are to determine how the study drug is absorbed, distributed, broken down, and removed from the body, how well it works compared to placebo as measured by improvement of disability, recovery, and physical function after a stroke. Patients are randomized to either the study drug or a placebo and take pills twice daily for a month starting 12 hours from last-known well after stroke.

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A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke

The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve cognitive and/or motor functioning in an individual following the occurrence of acute ischemic stroke. This is a 52-week, Phase 2a, randomized, double-blind, parallel-group, placebo-controlled, multicenter proof-of concept study.

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Sleep for Stroke Management And Recovery Trial

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

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AMPLATZER PFO Occluder Post Approval Study (PFO PAS)

Abbott developed the AMPLATZER™  PFO Occluder as a minimally invasive, transcatheter PFO closure treatment to further reduce the risk of recurrent stroke among patients with PFO and cryptogenic stroke beyond that achieved with medical management. This additional risk reduction is achieved by blocking the pathway for a venous embolism from reaching the body's arterial system and the brain. 

The safety and effectiveness of the AMPLATZER PFO Occluder was evaluated in RESPECT, a randomized controlled clinical trial conducted under an investigational device exemption (IDE), which was the largest trial of a transcatheter PFO closure device, with the longest follow-up. RESPECT demonstrated that the AMPLATZER PFO Occluder is effective in reducing recurrent ischemic stroke in subjects implanted with the device and can be implanted safely. The AMPLATZER PFO Occluder received market approval by FDA on October 28, 2016.

The purpose of this study is the continued evaluation of the long-term safety and effectiveness of the AMPLATZER PFO Occluder in a post approval setting. 

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AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke

ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NIH StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.

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Stroke and Young Adults: A qualitative assessment of the hospitalization for acute stroke, shared decision-making, and perception of risk

The purpose of this research study is to explore the challenges of recognizing stroke in young adults, the process of making treatment decisions, and the patient’s understanding of the risk of recurrence and long term consequences of stroke. This study consists of a 30 to 60 minute interview of patients with prior stroke (ischemic stroke, transient ischemic attack, or intracerebral hemorrhage) who were 18-50 years of age at the time of stroke onset.

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Ulnar Neuropathy


Ulnar neuropathy at the the elbow: protective role of the Martin Gruber anastomosis

The purpose of this study is to understand why some patients with nerve entrapment at the elbow do better than others. This study is investigational because it attempts to address the problem comprehensively, using different techniques, something that is not usually done for routine diagnostic purposes.

More