39 Clinical Trials for Various Conditions
Balance and aerobic training show promise as treatments for degenerative cerebellar diseases, but the neural effects of both training methods are unknown. The goal of this project is to evaluate how each training method impacts the brain, and particularly, the degenerating cerebellum. Various neuroimaging techniques will be used to accomplish this goal and test the hypothesis that balance training impacts brain structures outside the cerebellum whereas aerobic training causes more neuroplastic changes within the cerebellum.
The cerebellum has been linked to cognitive and emotional functions and there is increasing evidence that damage to posterior portions of the cerebellum can result in frontal-executive, visuospatial, and verbal deficits, including dysprosodia, and affective changes including blunting of affect or disinhibited and inappropriate behavior. Based on preliminary clinical observations and tests performed in the investigator's clinic, disorders of emotional communication may also be associated with cerebellar dysfunction. Emotional communication includes the production and comprehension of facial and prosodic expressions and is critical to maintaining positive and supportive relationships. Deficits in emotional communication can have devastating effects on relationships and on quality of life for those affected. Although deficits in affect and prosody have been reported in association with posterior cerebellar disorders, there are currently no studies systematically investigating emotional communication in individuals with cerebellar dysfunction. It is known that the cerebellum has strong connections with the cerebral cortex, especially the frontal lobes, and that cortical damage from stroke or neurodegenerative disease can result in disorders of emotional communication. Impairments in the integrity of cerebellar-cerebral networks from cerebellar disease may produce similar deficits in emotional communication. The purpose of this study is to systematically investigate and describe deficits in emotional communication in a series of patients with cerebellar disease. Participants will be individuals diagnosed with posterior cerebellar degeneration or damage from a non-hemorrhagic infarction, and age-matched neurologically healthy controls. Assessment will include a battery of tests of neuropsychological function as well as tests of emotional communication. Comprehension of emotional facial and prosodic expressions will be assessed as well as production of emotional communication. The expected outcomes will be to identify and describe deficits in production and comprehension of emotional prosodic and facial expressions and to describe the relationship between deficits in emotional communication and cerebellar atrophy with magnetic resonance imaging imaging (MRI) using voxel based morphometry (VBM).
Imaging studies of the brain have revealed the different areas involved in the processes of learning and reasoning. However, the specific role these regions play in these processes, or if stimulating these areas can improve these processes is unknown. Researchers would like to use repetitive transcranial stimulation (rTMS) to better understand the roles of individual brain regions on the processes of learning and reasoning. Repetitive transcranial magnetic stimulation (rTMS) involves the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp, and rapidly turning on and off the magnetic flux. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses. The purpose of this study is to use rTMS to help determine the roles of different brain regions in the development of implicit learning of motor sequences and analogic reasoning. In addition, researchers hope to evaluate if stimulation of these regions speeds up the process of learning or analogic reasoning.
The proposed study aims to characterize ataxia occurring in essential tremor and essential tremor with DBS.
This study will examine the role of certain areas of the brain in blepharospasm, a type of dystonia (abnormality of movement and muscle tone) that causes unwanted or uncontrollable blinking or closing of the eyelids. The study will compare brain activity in healthy volunteers and in people with blepharospasm to find differences in the brain that may lead to better treatments for dystonia. Healthy volunteers and people with blepharospasm who are 18 years of age and older may be eligible for this study. All candidates are screened with a medical history. People with blepharospasm also have a physical examination and blepharospasm rating. Participants undergo transcranial magnetic stimulation (TMS) and electromyography (EMG) in two 4-hour sessions, separated by 1 to 7 days. TMS A wire coil is held on the subject s scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the face, arm or leg. During the stimulation, subjects may be asked to tense certain muscles slightly or perform other simple actions. Repetitive TMS involves repeated magnetic pulses delivered in short bursts of impulses. Subjects receive 60 pulses per minute over 15 minutes. EMG Surface EMG is done during TMS to measure the electrical activity of muscles. For this test, electrodes (small metal disks) are filled with a conductive gel and taped to the skin of the face.
Episodic ataxia (EA) is a rare genetic disease characterized by episodes of imbalance, incoordination, and slurring of speech. The underlying cause of EA is only partly understood, and currently there are no established treatments. There is also little information about the link between EA's clinical features and its genetic basis. The purpose of this study is to better characterize EA and disease progression. In turn, this may direct the development of future treatments.
The aim of the research is to improve motor function in people with cerebellar ataxia by using neuroimaging methods and mental imagery to "exercise" motor networks in the brain. The relevance of this research to public health is that results have the potential to reduce motor deficits associated with cerebellar atrophy, thereby enhancing the quality of life and promoting independence.
This project will study the feasibility of motor rehabilitation in people with cerebellar ataxia using real-time functional magnetic resonance imaging neurofeedback (rt-fMRI NF) in conjunction with motor imagery. To do so, data will be collected from healthy adults in this protocol, to be compared with data from cerebellar ataxia participants.
The first aim is to show aerobic training improves degenerative cerebellar patients functionally The second aim is to compare the effects of balance and aerobic training on degenerative cerebellar disease.
Gait and balance disturbances are one of the most incapacitating symptoms of Parkinson's disease (PD) (Boonstra et al. 2008). They can cause falls and are therefore associated with the negative spiral of (near) falls, fear of falling, fractures, reduced mobility and social isolation; hence, having a profound negative impact on quality of life (Lin et al. 2012). Originally, symptoms of PD were ascribed to dopamine deficiency and basal ganglia dysfunction (Wu et al. 2013). However, in the last decades it has become clear that other brain structures are also involved in the pathophysiology of PD (Snijders et al. 2011; Stefani et al. 2007). An intriguing, emerging insight is that the cerebellum may be involved in the pathophysiology of PD (Wu et al. 2013). That is, the cerebellum is hyperactive in PD patients during different motor tasks (Yu et al. 2007; Hanakawa et al. 1999; del Olmo et al. 2006). However, whether cerebellar hyperactivity is pathological or compensatory and how it affects gait and balance in PD patients remain open questions. Here, the investigators aim to elucidate the role of the hyperactive cerebellum in gait dysfunction in PD patients by modulating cerebellar excitability with state-of-the-art non-invasive brain stimulation techniques and investigate the effects on gait.
The goal of this observational and interventional study is to better understand the involvement of the cerebellum in the brain reward system in persons with alcohol use disorder (AUD). The main questions it aims to answer are: 1. What is the nature of cerebellar input to the ventral tegmental area (VTA) in the brain reward system, and how is it perturbed in AUD? 2. What is the relationship between measures of cerebellar integrity and magnitude of reward activation to alcohol-related cues in cerebellar, VTA and other brain reward structures? 3. What is the therapeutic potential of cerebellar transcranial direct current stimulation (tDCS) for modulating alcohol cue reactivity, associated alcohol craving, and cerebellar - VTA functional connectivity in the brain reward system? Persons with AUD will be compared with healthy control participants.
The purpose of this study is to test the safety of placing Deep Brain Stimulators (DBS) in a part of the brain called the cerebellum and using electrical stimulation of that part of the brain to treat movement symptoms related to cerebral palsy. Ten children and young adults with dyskinetic cerebral palsy will be implanted with a Medtronic Percept Primary Cell Neurostimulator. We will pilot videotaped automated movement recognition techniques and formal gait analysis, as well as collect and characterize each subject's physiological and neuroimaging markers that may predict hyperkinetic pathological states and their response to therapeutic DBS.
The purpose of this research study is to investigate whether tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults with autism spectrum disorders (ASD) is safe and to examine its effects on some of the symptoms of ASD, such as repetitive behaviors and hyperactivity.
Parkinson's disease (PD) is the second most common neurodegenerative disorder and affects approximately 1 million people in the United States with total annual costs approaching 11 billion dollars. The most common symptoms of PD are tremor, stiffness, slowness, and trouble with balance/walking, which lead to severe impairments in performing activities of daily living. Current medical and surgical treatments for PD are either only mildly effective, expensive, or associated with a variety of side-effects. Therefore, the development of practical and effective add-ons to current therapeutic treatment approaches would have many benefits. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can affect brain activity and can help make long-term brain changes to improve functions like walking and balance. While a few initial research studies and review articles involving tDCS have concluded that tDCS may improve PD walking and balance, many results are not meaningful in real life and several crucial issues still prevent tDCS from being a useful add-on intervention in PD. These include the selection of stimulation sites (brain regions stimulated) and tDCS electrode placement. Most studies have targeted the motor cortex (brain region that controls intentional movement), but there is evidence that the cerebellum - which helps control gait and balance, is connected to several other brain areas, and is easily stimulated with tDCS - may be a likely location to further optimize walking and balance in PD. There is also evidence that certain electrodes placements may be better than others. Thus, the purpose of this study is to determine the effects of cerebellar tDCS stimulation using two different placement strategies on walking and balance in PD. Additionally, although many tDCS devices are capable of a range of stimulation intensities (for example, 0 mA - 5 mA), the intensities currently used in most tDCS research are less than 2 mA, which is sufficient to produce measurable improvements; but, these improvements may be expanded at higher intensities. In the beginning, when the safety of tDCS was still being established for human subjects, careful and moderate stimulation approaches were warranted. However, recent work using stimulation at higher intensities (for example, up to 4 mA) have been performed in different people and were found to have no additional negative side-effects. Now that the safety of tDCS at higher intensities is better established, studies exploring the differences in performance between moderate (i.e., 2 mA) and higher (i.e., 4 mA) intensities are necessary to determine if increasing the intensity increases the effectiveness of the desired outcome. Prospective participants will include 10 people with mild-moderate PD that will be recruited to complete five randomly-ordered stimulation sessions, separated by at least 5 days each. Each session will involve one visit to the Integrative Neurophysiology Laboratory (INPL) and will last for approximately one hour. Data collection is expected to take 4-6 months. Each session will include walking and balance testing performed while wearing the tDCS device. Total tDCS stimulation time for each session will be 25 minutes.
Hypothesis: Will the use of tDCS brain modulation in the cerebellum assist in restricted behaviors, social cognition and cognitive flexibility in women with anorexia nervosa in addition to other therapies? Primary Outcomes: 1. To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by Cyberball and Trust Game. 2. To observe the neuropsychological impacts of cerebellar tDCS through fMRI imaging as well as looking at the Region of Interest (ROI) of changes in the Default Mode Network and Cerebellum circuits and their activation levels in those networks. Secondary Outcomes: 1.To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) measuring the differences between anodal and cathodal stimulation. To observe potential increases in responses to social stimuli, decreases in eating disorder/depressive symptomology via cathodal stimulation. To also observe potential little to no changes in social stimuli and eating disorder/depressive symptomology via anodal stimulation.
The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks). Participants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.
The purpose of this research study is to investigate the effects of transcranial direct current stimulation (tDCS) on some of the challenges faced by children with Autism Spectrum Disorder (ASD).
The primary goal of this study is to address the need for targeted therapeutic interventions for impairments that impact walking in related neurodegenerative diseases.
This is a single-site, sham-controlled, randomized trial in a total of 60 subjects between ages 18 and 40 years with schizophrenia. This study will investigate the effects of 4-week rTMS treatment on brain and cognitive functions in patients. Subjects will be randomized to one of the following arms: Arm 1: Standard of Care (SOC) and active rTMS Arm 2: Standard of Care (SOC) and sham rTMS Each participant will receive rTMS five days per week, for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at baseline, end of the 2nd week, and end of the 4th week.
Engage-Ataxia will implement a physical activity coaching program for people with cerebellar ataxia at Teachers College, Columbia University. This program expands upon the current Engage program for people with Parkinson's disease (Engage-PD), an exercise coaching program for people with early stage Parkinson's disease to target individuals with early stage cerebellar ataxia. Engage-Ataxia will utilize a physical or occupational therapist to provide up to five one-on-one coaching sessions for individuals newly diagnosed with cerebellar ataxia. Therapists will work with participants to provide individualized structured support to facilitate and optimize exercise uptake as one part of comprehensive disease management. Participants will undertake two assessments three months apart, and will receive coaching interventions via Zoom healthcare platform. The primary objective of this program is to increase physical activity and exercise engagement in individuals with early stage cerebellar ataxia. This feasibility study will provide preliminary data and insight into the benefits of a remote coaching intervention for people with cerebellar ataxia.
The purpose of this study is to create a repository for cerebellar ataxia and nucleotide repeat diseases in order to fully investigate the genetic and phenotypic presentations of both.
This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested. Funding Source- FDA OOPD
The objective of the current study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) on self-reported negative affect, cerebellar brain activation and alcohol use outcomes in alcohol use disorder (AUD).
The first aim is to show balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression. The second aim is to demonstrate aerobic exercise improves balance and gait in DCD persons by affecting brain processes and slowing cerebellar atrophy.
Emerging neuroimaging studies have shown that the cerebellum contributes to different aspects of timing, prediction, learning, and extinction of conditioned responses to aversive stimuli, factors that may be relevant to the success of exposure based behavioral therapy. Our goals are to determine the cerebellar contributions to fear extinction by attempting to modulate key pathways in this process by theta burst stimulation. The long term goal is to lay the foundation for future studies in which neuromodulation is used to augment exposure therapy.
The purpose of this study is to examine whether cerebellar stimulation can be used to improve cognitive deficits and mood in patients with schizophrenia, autism, bipolar disorder, Parkinson's disease, and major depression.
Multiple system atrophy (MSA) is a disorder of the nervous system of unclear cause. In MSA there is degeneration (progressive loss) of nerve cells in several brain and spinal cord regions. The result is a variety of symptoms, from physical (parkinsonism, ataxia, incoordination, falls, slowness) to autonomic (fainting, bladder incontinence, sexual dysfunction) to sleep problems (dream enactment, sleep apnea). This research aims to help us better understand the patterns and timing of nerve degeneration relatively early in the disease, and how this affects symptoms and progression. For instance: 1. Does MSA affect certain nerves that stimulate heart pumping? If so, does the severity of loss of heart nerves affect disease progression and survival? 2. It is thought that MSA does not affect memory and thinking much, unlike other diseases (such as Parkinson's). Is this accurate? Is there loss of nerves that transmit acetylcholine (a neurochemical important in mental functioning)? 3. What can we learn about mood and sleep in MSA, through visualizing the serotonin system in the brain? How does this relate to symptoms that subjects report in these often underappreciated areas? To answer these and other questions, investigators will take images of specific nerves in the brain and heart using Positron Emission Tomography (PET) scans. Such imaging gives us information that cannot be obtained from MRIs and CT scans. We will measure the levels of several nerve cell types: serotonin, acetylcholine, and norepinephrine. Subjects will also have many standardized assessments including quality-of-life and symptom assessments, neurological examination, autonomic assessments, neuropsychological assessments, coordination tests, and even assessments of vision and sense of smell. By pooling these results from many MSA patients, and comparing with other diseases (such as Parkinson's disease) we hope to gain a better understanding of what is happening early in MSA. Such knowledge could be very valuable in future efforts to develop better therapies in this rare disease.
The purpose of this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor functions.
This phase II trial studies the side effects and how well carmustine, etoposide, cytarabine and melphalan together with antithymocyte globulin before a stem cell transplant works in treating patients with autoimmune neurologic disease that did not respond to previous therapy. In autoimmune neurological diseases, the patient's own immune system 'attacks' the nervous system which might include the brain/spinal cord and/or the peripheral nerves. Giving high-dose chemotherapy, including carmustine, etoposide, cytarabine, melphalan, and antithymocyte globulin, before a stem cell transplant weakens the immune system and may help stop the immune system from 'attacking' a patient's nervous system. When the patient's own (autologous) stem cells are infused into the patient they help the bone marrow make red blood cells, white blood cells, and platelets so the blood counts can improve.
This study will screen patients with cerebellar ataxia to check for antibodies that indicate allergy to gluten (wheat protein) and will study the effect of a gluten-free diet in patients with these antibodies. Patients with cerebellar ataxia have problems with coordination, resulting in "clumsiness" and unsteadiness of posture and walking. There are many known causes of cerebellar ataxia, but in many patients the cause is unknown and there are no available treatments. Cerebellar ataxia has been recognized as a complication of celiac disease, a syndrome characterized by sensitivity to gluten. Recognizing gluten sensitivity in patients with cerebellar ataxia would be important for two reasons: it would be one of the rare causes of the disease that are potentially treatable, and it would identify patients at risk for developing gastrointestinal cancers, particularly intestinal lymphoma. Patients with cerebellar ataxia of known or unknown cause and normal healthy volunteers of any age are eligible for this study. All participants will have a medical history, physical examination, blood drawn (30 milliliters, or 2 tablespoons) to check for celiac disease antibodies, and possibly other lab tests. This completes the participation of normal volunteers. All patients will have magnetic resonance imaging (MRI) of the brain. This diagnostic tool uses a strong magnetic field and radio waves instead of X-rays to show structural and chemical changes in tissues. During the scanning, the patient lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member via an intercom system at all times during the procedure. Scanning times vary from 20 minutes to 2 hours. Patients who have celiac disease antibodies will have an upper gastrointestinal (GI) endoscopy intestinal biopsy. For this procedure, a flexible tube is inserted into the mouth and down the throat into the stomach and duodenum (the upper part of the small intestine), where a small tissue sample is taken for microscopic examination. Patients with these antibodies will be put on a gluten-free diet and will be followed at NIH every 3 months for 12 months. On the first visit, patients will have their ataxia evaluated using NINDS's ataxia scale and will meet with a dietitian for instructions for a gluten-free diet. On the second through fifth visits (after 3, 6, 9 and 12 months, respectively, on the gluten-free diet), patients will have their ataxia evaluated, speak with a dietitian to assess their nutritional status, weight, and compliance with the diet, and provide a blood sample for celiac disease antibody testing. At the completion of the study, patients may choose to continue or stop the gluten-free diet. If the ataxia assessments show improvement, patients will be advised to continue the gluten-free diet permanently.