35 result(s) found
Aneurysms
The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration after cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome 90 days after patient discharge following in-hospital optimal intra-arterial drug treatment for cerebral vasospasm. This study is a prospective multicenter randomized trial.
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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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Glioblastoma
This is a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study, with the objective of comparing Progression-Free Survival (PFS) in newly diagnosed GBM patients treated with IGV-001 with patients treated with placebo.
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This is a phase I trial to see whether patients are able to adhere to a modified, high fat/low carbohydrate diet (the sHFLC + KetoPhyt Diet) with a supplement named KetoPhyt that includes ketones and anti-inflammatory properties.
The classic ketogenic diet (KD) is difficult for patients to adhere to due to its stringent nature. A modified KD has been developed that mimics the glucose lowering, ketone raising effects and the anti-cancer outcomes of the KD.
The sHFLC + KetoPhyt diet will be implemented in a cohort of 10 Glioblastoma patients, who will be trained and provided with sample meal plans so as to maintain their carbohydrate levels up to 33% of total caloric intake. The study will determine whether participants can maintain the diet and the ketogenic state.
This study will also conduct molecular analyses to determine the effect of the diet on the microbiome, inflammatory cytokines, and extracellular vesicle content.
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Glioblastoma Multiforme
This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Approximately 210 patients with Glioblastoma Multiforme (GBM) after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of overall survival
In this research study, an investigational medication named berubicin is being compared to lomustine (an approved chemotherapy medication) for the treatment of recurrent GBM.
The main purpose of this study is to investigate how effective berubicin is in treating GBM that has recurred after initial standard therapy, and comparing this with lomustine. The study also aims to assess the safety of berubicin and how it is absorbed by and cleared from the body. Both medications are designed to slow or stop the growth of cancer cells.
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Healthy Volunteers
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
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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ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.
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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
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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Migraine
The purpose of this study is to collect information about treatment patterns, effects, and outcomes in patients with migraines who are switching or initiating a pharmacologic treatment for migraine prevention. This is an observational study which means there will be no treatment added or taken away.
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Multiple Sclerosis
The purpose of the study is to assess the efficacy and safety of SAR442168 compared with teriflunomide (Aubagio) in participants with relapsing multiple sclerosis (RMS).
The experimental drug works in the blood and in the brain where it blocks a molecule called “Bruton's tyrosine kinase (BTK)”, which is present in some cells involved in multiple sclerosis (immune cells known as B-cells and microglial cells). This mechanism of action may help stop the formation of new brain lesions in MS.
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The purpose of the study is to see if the study drug, SAR442168, works to delay the progression of disability in people with NRSPMS compared to placebo and has an acceptable safety profile.
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The purpose of the study is to see if the study drug, SAR442168, works to delay the progression of disability in people with PPMS compared to placebo and has an acceptable safety profile.
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To demonstrate that remibrutinib is superior to teriflunomide in reducing the frequency of confirmed relapses.
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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
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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Neurologic Diseases
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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Optic Neuritis
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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Spine Injuries and Disorders
The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve function in patients with acute traumatic cervical spinal cord injury (SCI).
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Status Epilepticus
Status Epilepticus(SE) is a serious condition that needs fast treatment to stop the seizures and prevent permanent brain damage. The purpose of this research is to find out if ganaxolone can stop or decrease the seizure activity in participants who have SE and if ganaxolone is safe compared to placebo when given to participants who are on other anti-seizure medications.
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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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The purpose of this research is to enhance and support our understanding and evaluating actual response behaviors of cognitive disability in realistic tasks. We hope to obtain more information about the response behaviors to stimuli during simulated driving of a typical cohort compared to post-stroke cohorts.
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The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE)
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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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The purpose of this study is to learn if asundexian is safe for the participants, how it affects the body, and to look at how well it works to prevent future ischemic strokes in participants who already had had an acute non-cardioembolic ischemic stroke or high-risk TIA.
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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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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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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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This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight. The Halo Alert System consists of an EEG sensor headband (Muse-S headband from Interaxon, Inc., Toronto Canada) paired with a data transfer device (Zeit Loop, Zeit Medical, Inc., Redwood City, CA).
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Subarachnoid Hemorrhage
The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration after cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome 90 days after patient discharge following in-hospital optimal intra-arterial drug treatment for cerebral vasospasm. This study is a prospective multicenter randomized trial.
More
Transient Ischemic Attack
The purpose of this study is to learn if asundexian is safe for the participants, how it affects the body, and to look at how well it works to prevent future ischemic strokes in participants who already had had an acute non-cardioembolic ischemic stroke or high-risk TIA.
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Transthyretin Cardiac Amyloidosis
This is an observational study to assess the the burden of neuropathic involvement in wild-type transthyretin amyloidosis
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Tremor
To evaluate the efficacy and safety of Botulinum Toxin Type A PUrified Neurotoxin Complex (BOTOX) compared to placebo for the treatment of upper limb essential tremor.
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This is a global, multi-center, noninterventional study that will collect data on patients with PD under standard-of-care treatment according to local routine clinical practice. The primary objective of the study is to assess the impact of the frequency of assessments on the variability over time, reliability, and compliance for the PD diary in patients with PD in whom medications do not provide adequate control of symptoms. The secondary objectives of the study are to document changes in motor function as a measure of disease progression and characterize the stability or rates of change on motor function, quality of life, and use of standard PD medications in patients with PD in whom medications do not provide adequate control of symptoms.
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