Current Studies
ClinicalTrials.gov Identifier: NCT05836987
The Rhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation (REACT-AF) clinical trial compares the current standard of care for AF versus a novel strategy of precise, time-delimited, direct oral anticoagulation (DOAC) guided by an AF-sensing smartwatch.
Muscle Stiffness
ClinicalTrials.gov Identifier: NCT03306615
Peripheral Modulation of Muscle Stiffness and Spasticity (also called Muscle Stiffness) is a cross-over trial of hyaluronidase to reverse upper limb muscle stiffness in patients who have suffered neurologic injury (stroke, spinal cord injury, etc.). Participants will be injected with hyaluronidase, which is an enzyme that helps break down hyaluronic acid (hyaluronan). A cross-over trial is a type of clinical trial comparing two or more interventions in which the participants, after completing the course of one treatment, are switched to another treatment. For this trial, subjects will be randomized to either the study drug or placebo in phase 1 and will switch to the other treatment in phase 2.
ClinicalTrials.gov Identifier: NCT04039464
Kids MoD PAH (Mono- vs. Duo Therapy for Pediatric Pulmonary Arterial Hypertension) will be the first investigator-initiated multicenter randomized clinical trial in North America to study the best initial therapy for children with pulmonary hypertension. Pulmonary hypertension is a rare kind of high blood pressure that affects the heart and lungs.
ClinicalTrials.gov Identifier: NCT03734640
OPTIMISTmain (Optimal Post Tpa-Iv Monitoring in Ischemic Stroke) is an international trial comparing the impact of different intensities of nursing care monitoring for acute ischemic stroke patients who have received treatment with recombinant tissue plasminogen activator (rtPA). When conducted in a timely manner, treatment with rtPA can offer acute ischemic stroke patients a life without major disability.
REST
ClinicalTrials.gov Identifier: NCT05282550
Targeting Cognition in Early Alzheimer’s Disease by Improving Sleep with Trazodone (REST) is a phase 2 clinical trial examining trazodone’s effect on sleep in patients with amnestic mild cognitive impairment (aMCI). Secondary outcomes include assessments of the treatment’s effect on cognition, memory, biomarkers of Alzheimer’s disease (AD) pathology, and hippocampal function and excitability (brain structure involved with memory and learning). Healthy sleep is crucial for hippocampal-dependent memory consolidation. Studies have shown that improving sleep can positively alter the course of AD.
ClinicalTrials.gov Identifier: NCT05020535
Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) is a trial studying the safety and tolerability of MW01-6-189WH, a small-molecule drug called MW189, in patients with intracerebral hemorrhage (ICH). There currently is no approved treatment for ICH, a condition that results in high rates of mortality and long-term disability.
ClinicalTrials.gov Identifier: NCT03101891
Renal Anhydramnios Fetal Therapy (RAFT) is a clinical trial focused on helping combat the effects of early pregnancy renal anhydramnios (EPRA). EPRA is a condition where there is no amniotic fluid around the fetus in the womb. It occurs either because the fetus does not have kidneys or the kidneys do not function, preventing the fetus from producing urine, which typically makes up most of the amniotic fluid. EPRA is thought to be universally fatal at birth because lungs cannot develop in utero without amniotic fluid.
ClinicalTrials.gov Identifier: NCT04098666
The Metformin in Alzheimer’s dementia Prevention (MAP) trial is a randomized controlled phase 2/3 trial comparing the effects of long-acting metformin (reduced mass Glucophage XR), which is a drug approved to treat diabetes, versus placebo in the prevention of cognitive decline. The study will measure changes over 24 months in verbal memory performance in persons with mild cognitive impairment who are at risk of developing Alzheimer’s. The trial is supported by the Trial Innovation Network and funded by the NIH National Institute on Aging. BIOS CTCC serves as the data coordinating center, site start-up manager, and central imaging center.
ClinicalTrials.gov Identifier: NCT03500328
The Traditional versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) Trial is a randomized controlled trial that will recruit 900 patients across approximately 45 sites within the United States. It will help inform patients and the broader healthcare community on whether patients would most benefit from early, possibly more risky aggressive therapy or if starting with a less aggressive (and, often, less risky) therapy, followed by a switch if breakthrough disease activity occurs, is warranted. In addition, this study will help identify if there is a specific patient population or short-term biomarker(s) that is strongly predictive of long-term disability that can result from MS. This trial is supported by the Trial Innovation Network, and BIOS CTCC is serving as the coordinating center.
ClinicalTrials.gov Identifier: NCT05081128
Placebo-Controlled Efficacy in iNPH Shunting (PENS) is a multi-institutional, randomized, double-blinded, placebo-controlled clinical trial funded by the National Institute of Neurological Disorders and Stroke. PENS is assessing the effectiveness of surgical cerebrospinal fluid shunting for idiopathic normal pressure hydrocephalus (iNPH) treatment.
Brain cavernous angiomas with symptomatic hemorrhage (CASH) are rare, but they exact a heavy burden of neurologic disability from recurrent bleeding, for which there is no proven therapy. This is an observational cohort study with no intervention. This project will address gaps in knowledge and barriers to clinical trial readiness.
The Atorvastatin Treatment of Cavernous Angiomas With Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) trial is a phase 1/2a randomized, placebo-controlled, double-blinded, single-site clinical trial. It is investigating the effect of atorvastatin versus placebo on cavernous angioma lesional iron deposition using validated quantitative susceptibility mapping MRI studies in patients who suffered a symptomatic bleed within the past year.
The Type 2 Diabetes Prevention with Airway Pressure trial (DPAP Trial) is a prospective multicenter randomized trial sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. The trial, which is in its planning phase, will investigate whether treatment of obstructive sleep apnea with positive airway pressure therapy is associated with a decrease in the incidence of type 2 diabetes in people with prediabetes. BIOS CTCC serves as the data coordinating center.
ClinicalTrials.gov Identifier: NCT02483429
AVERT is a randomized multicenter clinical trial evaluating video-oculography (VOG), nystagmography, and audiometry in patients presenting to an emergency department with dizziness or vertigo. The study is designed to determine if these non-invasive tests of eye movement and hearing when combined with a structured treatment plan, resulting in a better diagnosis. BIOS CTCC serves as the clinical trial coordinating center and data management center.
ClinicalTrials.gov Identifier: NCT01389024
HU Prevent is a clinical study that aims to compare the drug hydroxyurea to a placebo in children with sickle cell disease. The goal of this clinical trial is to determine if hydroxyurea can prevent brain injury. Some of the most devastating complications of sickle cell disease, including stroke, silent stroke, and fast blood flow to the brain, can occur early in a child’s life. Through information gained from the HU Prevent Study, we hope to help prevent these common problems in children with sickle cell disease. BIOS CTCC is serving as the national coordinating center.