Clinical Trials in the Spotlight

Returning 42 results

Acute Ischemic Stroke

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

SHINE is a multicenter, randomized, controlled clinical trial of 1400 participants that will include approximately 60 sites across the country. The trial will evaluate if blood sugar control is safe and effective for improving stroke recovery. The research sites will be testing the current standard treatment against the administration of a controlled IV insulin infusion therapy within 12 hours of the onset of stroke symptoms. The treatment lasts for up to three days.

ALS

Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation

The purpose of the Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation study (13-N-0188) is to describe the natural history of disease in people who carry a repeat expansion mutation in the C9ORF72 gene. This gene can cause amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). The second goal of this study is to find out if C9ORF72 biomarkers relate to how the disease progresses.

Benzodiazepine Refractory Status Epilepticus

Established Status Epilepticus Treatment Trial

The primary objective is to determine the most effective and/or the least effective treatment of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and valproic acid (VPA). The second objective is comparison of three drugs with respect to secondary outcomes. The final objective is to ensure that the trial is informative for treatment of established SE in children by describing the effectiveness, safety, and rate of adverse reactions of these drugs in children.

Brain and Spinal Tumors

Evaluation and Treatment of Neurosurgical Disorders

The Evaluation and Treatment of Neurosurgical Disorders research study (03-N-0164) will evaluate people with a variety of neurosurgical disorders in order to provide standard expert care and physician training. In the study, doctors will assess and treat people who have disorders of the brain, spinal cord, peripheral nerves, or pituitary gland that may or may not require surgery. This study will not test new treatments. Participants will receive standard care.

Tumor Related Epilepsy

The Tumor Related Epilepsy research study (16-N-0041) will evaluate and offer surgery to people with tumor-related epilepsy, and explore how surgery affects seizures. Some people who have brain tumors have seizures related to the tumor, which is a condition called tumor-related epilepsy. The standard treatment for people with brain tumors is surgery to remove as much of the tumor as possible without causing additional neurological problems. Researchers think this method of treatment may improve the outcome for people with brain tumors because it may completely relieve or greatly reduce the...

Brain Neoplasm

Tumor Related Epilepsy

The Tumor Related Epilepsy research study (16-N-0041) will evaluate and offer surgery to people with tumor-related epilepsy, and explore how surgery affects seizures. Some people who have brain tumors have seizures related to the tumor, which is a condition called tumor-related epilepsy. The standard treatment for people with brain tumors is surgery to remove as much of the tumor as possible without causing additional neurological problems. Researchers think this method of treatment may improve the outcome for people with brain tumors because it may completely relieve or greatly reduce the...

Cancer

Tumor Related Epilepsy

The Tumor Related Epilepsy research study (16-N-0041) will evaluate and offer surgery to people with tumor-related epilepsy, and explore how surgery affects seizures. Some people who have brain tumors have seizures related to the tumor, which is a condition called tumor-related epilepsy. The standard treatment for people with brain tumors is surgery to remove as much of the tumor as possible without causing additional neurological problems. Researchers think this method of treatment may improve the outcome for people with brain tumors because it may completely relieve or greatly reduce the...

Carotid Stenosis

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)

Carotid revascularization for primary prevention of stroke (CREST-2) consists of 2 parallel, randomized clinical trials.  One trial will compare intensive medical management to carotid endarterectomy plus intensive medical management.  The parallel trial will compare intensive medical management to carotid artery stenting plus intensive medical management. Intensive medical management will involve a lifestyle intervention to monitor and manage risk factors such as blood pressure, cholesterol, smoking cessation, weight loss, and physical activity.

Cryptococcal Meningitis

Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

This is a phase III trial to determine whether adjunctive sertraline will lead to improved survival 18-week survival. There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF concentrations in 172 persons conducted from August 2013 to August 2014..

Dementia

Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation

The purpose of the Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation study (13-N-0188) is to describe the natural history of disease in people who carry a repeat expansion mutation in the C9ORF72 gene. This gene can cause amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). The second goal of this study is to find out if C9ORF72 biomarkers relate to how the disease progresses.

Dystonia

Deep Brain Stimulation Surgery for Movement Disorders

The Deep Brain Stimulation Surgery for Movement Disorders study (11-N-0211) uses deep brain stimulation (DBS) to treat Parkinson’s disease, dystonia, and essential tremor. DBS is an approved surgical procedure for these neurological conditions which do not respond well to other treatments. The objective of this research is to study normal human biology and disease pathogenesis (natural history) and to collect physiology and efficacy data related to DBS therapy and motor and cognitive function in the study population.

Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity

Background: - It is hard for people with arm spasticity and focal hand dystonia to control their arm and hand muscles. They are often treated with botulinum toxin (BoNT) injections. Electromyography with electrical stimulation (e-stim) and ultrasound are used to find muscles for BoNT injection. Researchers want to learn which method is faster and more comfortable. Objective: - To compare 2 ways of finding muscles for BoNT injection for the treatment of focal hand dystonia and upper limb spasticity. Eligibility: - Adults 18 and older with focal hand dystonia or arm spasticity who have been...

Epilepsy

Established Status Epilepticus Treatment Trial

The primary objective is to determine the most effective and/or the least effective treatment of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and valproic acid (VPA). The second objective is comparison of three drugs with respect to secondary outcomes. The final objective is to ensure that the trial is informative for treatment of established SE in children by describing the effectiveness, safety, and rate of adverse reactions of these drugs in children.

Surgery as a Treatment for Medically Intractable Epilepsy

Medically-intractable or uncontrolled epilepsy is a type of epilepsy that cannot be controlled with medication. Some people whose seizures do not respond to medication may respond to surgery. The purpose of the Surgery as a Treatment for Medically Intractable Epilepsy study (11-N-0051) is to learn more about medically-intractable or uncontrolled epilepsy and its treatment. Standard epilepsy treatment, including the possibility of surgery if needed, will be provided to participants.

PRX-00023 Therapy in Localization-Related Epilepsy

The purpose of the PRX-00023 Therapy in Localization-Related Epilepsy study (11-N-0039) is to find out if an experimental drug called PRX-00023 reduces the frequency of seizures in people with localization-related epilepsy. Localization-related epilepsy is a type of epilepsy that starts in only one part of the brain.

Tumor Related Epilepsy

The Tumor Related Epilepsy research study (16-N-0041) will evaluate and offer surgery to people with tumor-related epilepsy, and explore how surgery affects seizures. Some people who have brain tumors have seizures related to the tumor, which is a condition called tumor-related epilepsy. The standard treatment for people with brain tumors is surgery to remove as much of the tumor as possible without causing additional neurological problems. Researchers think this method of treatment may improve the outcome for people with brain tumors because it may completely relieve or greatly reduce the...

Focal Dystonia

Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity

Background: - It is hard for people with arm spasticity and focal hand dystonia to control their arm and hand muscles. They are often treated with botulinum toxin (BoNT) injections. Electromyography with electrical stimulation (e-stim) and ultrasound are used to find muscles for BoNT injection. Researchers want to learn which method is faster and more comfortable. Objective: - To compare 2 ways of finding muscles for BoNT injection for the treatment of focal hand dystonia and upper limb spasticity. Eligibility: - Adults 18 and older with focal hand dystonia or arm spasticity who have been...

Frontotemporal Dementia

Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation

The purpose of the Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation study (13-N-0188) is to describe the natural history of disease in people who carry a repeat expansion mutation in the C9ORF72 gene. This gene can cause amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). The second goal of this study is to find out if C9ORF72 biomarkers relate to how the disease progresses.

Fungal Meningitis

Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

This is a phase III trial to determine whether adjunctive sertraline will lead to improved survival 18-week survival. There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF concentrations in 172 persons conducted from August 2013 to August 2014..

Intracerebral Hemorrhage

Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III (MISTIE III)

The Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III (MISTIE III) trial will test a minimally invasive surgical procedure with a drug called rt-PA (recombinant tissue plasminogen activator) as a treatment for intracerebral hemorrhage (ICH). ICH occurs when a blood vessel in part of the brain bursts open, causing blood to leak into the brain and clot.  Currently, there is no standard treatment for ICH and most people with ICH face a long recovery and have long term deficits.

Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial

The Intracerebral Hemorrhage Deferoxamine (iDEF) trial will study the effects of deferoxamine on brain or intracranial hemorrhage (ICH). This trial also will help researchers learn more about the safety of the drug. ICH occurs when a blood vessel in the brain bursts open. This causes blood to leak into the brain and may lead to a hemorrhagic stroke. A hemorrhagic stroke occurs when blood flow to a part of the brain stops. The blood in the brain also contains iron, which damages the brain. The focus of this multi-center, double-blind, placebo-controlled study is to evaluate deferoxamine...

Ischemic Stroke

Safety Evaluation of 3K3A-APC in Ischemic Stroke (RHAPSODY)

The Safety Evaluation of 3K3A-APC in Ischemic Stroke (RHAPSODY) trial will determine if the drug 3K3A-APC is safe at different dose levels in people who have had a stroke and received treatment with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy (clot removal with a device), or both.

Muscle Spasticity

Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity

Background: - It is hard for people with arm spasticity and focal hand dystonia to control their arm and hand muscles. They are often treated with botulinum toxin (BoNT) injections. Electromyography with electrical stimulation (e-stim) and ultrasound are used to find muscles for BoNT injection. Researchers want to learn which method is faster and more comfortable. Objective: - To compare 2 ways of finding muscles for BoNT injection for the treatment of focal hand dystonia and upper limb spasticity. Eligibility: - Adults 18 and older with focal hand dystonia or arm spasticity who have been...

Musician's Dystonia

Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity

Background: - It is hard for people with arm spasticity and focal hand dystonia to control their arm and hand muscles. They are often treated with botulinum toxin (BoNT) injections. Electromyography with electrical stimulation (e-stim) and ultrasound are used to find muscles for BoNT injection. Researchers want to learn which method is faster and more comfortable. Objective: - To compare 2 ways of finding muscles for BoNT injection for the treatment of focal hand dystonia and upper limb spasticity. Eligibility: - Adults 18 and older with focal hand dystonia or arm spasticity who have been...

Myasthenia Gravis

Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy

The purpose of this trial is to determine if thymectomy combined with prednisone therapy is more beneficial in treating non-thymomatous myasthenia gravis than prednisone therapy alone.

Parkinson's Disease

Deep Brain Stimulation Surgery for Movement Disorders

The Deep Brain Stimulation Surgery for Movement Disorders study (11-N-0211) uses deep brain stimulation (DBS) to treat Parkinson’s disease, dystonia, and essential tremor. DBS is an approved surgical procedure for these neurological conditions which do not respond well to other treatments. The objective of this research is to study normal human biology and disease pathogenesis (natural history) and to collect physiology and efficacy data related to DBS therapy and motor and cognitive function in the study population.

Study of Urate Elevation in Parkinson's Disease, Phase 3 (SURE-PD3)

The Study of Urate Elevation in Parkinson's Disease, Phase 3 (SURE-PD3) trial will determine if taking inosine at doses that raise urate levels can slow the progression of Parkinson’s disease (PD).

Sickle Cell Disease

Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II

The overall goal of this proposal is to conduct a partial double-blind randomized Phase III clinical trial for primary stroke prevention in children with sickle cell anemia (SCA) in sub-Saharan Africa.

Stroke

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)

Carotid revascularization for primary prevention of stroke (CREST-2) consists of 2 parallel, randomized clinical trials.  One trial will compare intensive medical management to carotid endarterectomy plus intensive medical management.  The parallel trial will compare intensive medical management to carotid artery stenting plus intensive medical management. Intensive medical management will involve a lifestyle intervention to monitor and manage risk factors such as blood pressure, cholesterol, smoking cessation, weight loss, and physical activity.

THrombolysis for Acute Wake-up and Unclear-onset Strokes With Alteplase at 0.6 mg/kg Trial (THAWS)

The purpose of this study is to clarify efficacy and safety of MRI-based intravenous thrombolysis with alteplase for patients with acute wake-up ischemic stroke and those having acute ischemic stroke with unknown time of symptom onset.

Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III (MISTIE III)

The Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III (MISTIE III) trial will test a minimally invasive surgical procedure with a drug called rt-PA (recombinant tissue plasminogen activator) as a treatment for intracerebral hemorrhage (ICH). ICH occurs when a blood vessel in part of the brain bursts open, causing blood to leak into the brain and clot.  Currently, there is no standard treatment for ICH and most people with ICH face a long recovery and have long term deficits.

Safety Evaluation of 3K3A-APC in Ischemic Stroke (RHAPSODY)

The Safety Evaluation of 3K3A-APC in Ischemic Stroke (RHAPSODY) trial will determine if the drug 3K3A-APC is safe at different dose levels in people who have had a stroke and received treatment with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy (clot removal with a device), or both.

Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT)

The Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial will determine if the drug clopidogrel (used to reduce or prevent blood clots) combined with aspirin is effective in preventing ischemic stroke and myocardial infarction (heart attack).

The Neurotrophic Effects of Lithium Carbonate Following Stroke: A Feasibility Study

Stroke is the leading cause of adult disability and the third leading cause of death in Canada. Most stroke survivors live with residual impairments that diminish independence and quality of life. This may include vascular cognitive impairment (loss of ability to plan, think and reason) which can lead to dementia and loss of mental and functional independence. The current treatment to reduce stroke induced brain tissue injury is limited to thrombolytics (clot busters), a therapy useful only if given in the first hours following stroke. One major new approach aims to reduce cell death after...

Telerehabilitation in the Home vs. Therapy In-Clinic for Patients with Stroke

The Telerehabilitation in the Home vs. Therapy In-Clinic for Patients with Stroke trial will determine if a home-based telerehabilitation therapy system is as good as in-clinic rehabilitation in helping people recover from stroke. This trial also will discover if providing educational materials improves understanding of stroke prevention and risk factor control.

Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II

The overall goal of this proposal is to conduct a partial double-blind randomized Phase III clinical trial for primary stroke prevention in children with sickle cell anemia (SCA) in sub-Saharan Africa.

Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial

The Intracerebral Hemorrhage Deferoxamine (iDEF) trial will study the effects of deferoxamine on brain or intracranial hemorrhage (ICH). This trial also will help researchers learn more about the safety of the drug. ICH occurs when a blood vessel in the brain bursts open. This causes blood to leak into the brain and may lead to a hemorrhagic stroke. A hemorrhagic stroke occurs when blood flow to a part of the brain stops. The blood in the brain also contains iron, which damages the brain. The focus of this multi-center, double-blind, placebo-controlled study is to evaluate deferoxamine...

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

SHINE is a multicenter, randomized, controlled clinical trial of 1400 participants that will include approximately 60 sites across the country. The trial will evaluate if blood sugar control is safe and effective for improving stroke recovery. The research sites will be testing the current standard treatment against the administration of a controlled IV insulin infusion therapy within 12 hours of the onset of stroke symptoms. The treatment lasts for up to three days.

Traumatic Brain Injury

Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury

The purpose of the Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury (TBI) study is to determine if bone marrow mononuclear (or white blood) cells (BMMNCs) can improve brain structure and neurocognitive or functional outcomes in children with severe TBI. BMMNCs are made up of a mixture of cells, including stem cells. Stem cells are cells that have the potential to develop into some or many different cell types in the body.

ADAPT

The ADAPT study will evaluate the effectiveness of different medical therapies on children with severe traumatic brain injury (TBI).

Each year TBI contributes to a substantial number of deaths and cases of permanent disability.   In fact, TBI is a contributing factor to a third of all injury-related deaths in the United States. 

Transforming Research and Clinical Knowledge in Traumatic Brain Injury

Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) is a large, multi-center study that aims to improve both the classification methods for diagnosis of TBI and the evaluation of patient outcomes and clinical practices in order to improve the design of clinical trials.

Tremor

Deep Brain Stimulation Surgery for Movement Disorders

The Deep Brain Stimulation Surgery for Movement Disorders study (11-N-0211) uses deep brain stimulation (DBS) to treat Parkinson’s disease, dystonia, and essential tremor. DBS is an approved surgical procedure for these neurological conditions which do not respond well to other treatments. The objective of this research is to study normal human biology and disease pathogenesis (natural history) and to collect physiology and efficacy data related to DBS therapy and motor and cognitive function in the study population.