Active clinical trials for "Parkinson Disease"

This study occurs during five visits that are already scheduled as part of "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688). If participants have dystonia associated with Parkinson's disease, the investigators will consent and administer one additional rating scale (Burke-Fahn-Marsden Dystonia Rating Scale) to assess the severity of dystonia.

The aim of the study is to constitute a proof of concept study for a larger study investigating the effect of mindfulness on anxiety and agitation in Parkinson's disease (PD) based on the results of a preliminary feasibility.

In patients with Parkinson's disease, the characteristic motor symptoms, i.e., slowness of movement (bradykinesia), tremor and rigidity, are consequences of the progressive degeneration of neurons containing and releasing dopamine. The first-line treatment of Parkinson´s is oral administration of levodopa - a precursor to dopamine that (unlike dopamine) passes the blood brain barrier. After the first few years of treatment with levodopa, many patients do however develop a highly variable response to the drug characterised by rapid shifts between impaired locomotion and drug induced dyskinesias (referred to as the on-off syndrome). This is cased by the marked variation in serum levodopa levels following per oral administration, and it is known that intravenous administration of levodopa give a more stable level of levodopa with improved on-off symptoms. Levodopa-carbidopa intestinal gel (LCIG) - under the name of Duodopa® - is delivered directly to the proximal jejunum via a tube connected to a portable infusion pump. Infusion of Duodopa in the jejunum bypasses gastric emptying, helping to avoid the fluctuation in plasma levodopa levels. However, while clearly confirming that an even administration of levodopa is of considerable benefit to Parkinson patients with on-off symptomatology, the LCIG approach is marred by the need for surgery (for the insertion of the intestinal tube) and various possible complications following this, as well as by side effects such as abdominal pain. Researchers have now succeeded in producing a physiologically acceptable levodopa solution (called Infudopa) in a concentration allowing for a continuous intravenous (i.v.) or subcutaneous (s.c.) administration of therapeutic doses to humans. Early experience of this strategy confirms that both s.c. and i.v. administration of this solution results in even serum levodopa levels and markedly improved motor functioning. The aim of this study is to compare the pharmacokinetic profile of Infudopa administered i.v. and s.c. with that of Duodopa administered enterally in parkinsonian patients with on-off complications.

Recently, Mark Morris Dance Group, and created Moving Through Glass (MTG), a project that was funded by Google, as a portable, round-the-clock extension of the internationally acclaimed Dance for Parkinson's Disease (PD)®. When a user activates Glass, participants can choose from a variety of different exercises, like "warm me up" or "balance me." Once selected, they see the founder instructors of the Dance for PD® projected in front of them. As a single site research study at Syracuse University, researchers are conducting the pilot phase of the research project. The purpose of the study is to investigate the impact of MTG on quality of life and motor functions (i.e. balance, gait, fall efficacy). Participation in the study required three visits to Women's Building in a period of four weeks and about 1-3 hours of the participant's time at each visit. During the first visit, 1 participants reviewed the consent form, completed Montreal Cognitive Assessment (MOCA) and if qualified participated in a face-to-face interview. Participants were given survey package to fill out at home and were given a week to complete all the paperwork. On the second visit, they returned the completed survey package, were given physical assessments and were taught how to use Google Glass. The participants left with Google Glass, log sheet, and survey package. After 3 weeks, participants came to Women's Building for the last visit and the physical assessments were repeated, followed by an exit interview.

The purpose of this study is to measure neural activity during deep brain stimulation (DBS). There are two types of neural activity that we will record from DBS electrodes during this study: DBS local evoked potentials (DLEPs) and spontaneous, local field potentials (LFPs). We will measure the effects of varying stimulation parameters on both the neural activity and changes in motor symptoms -- bradykinesia and tremor -- in subjects with Parkinson's disease (PD). Correlating neural activity characteristics with changes in symptoms will improve our understanding of the mechanisms of action of DBS. This intraoperative study will specifically compare our ability to record neural activity using circuitry developed at Duke for this purpose [Kent et al, 2015] to a new, implanted pulse generator (IPG; RC+S) developed by Medtronic. These intraoperative studies will specifically test a preliminary version of the RC+S (that is not designed for implantation), and will lead to a clinical trial assessing the efficacy of the implantable RC+S IPG in PD patients once this device is available and approved for this trial.

The pathology of Parkinson's disease (PD) and the mechanism of Deep Brain Stimulation surgery (DBS) are not completely understood. The recording data that is used routinely as part of the procedure to map the target structures, however, may be analyzed in order to better understand the neural network dynamics in PD. The purpose of the study is to perform simultaneous neural recordings from sub-cortical structures (e.g. subthalamic nucleus [STN] or globus pallidus internus [GPi]) and the cerebral cortex. These simultaneous recordings may provide insight in the pathology of PD and the mechanism of DBS. The researchers will also study the effects of anesthesia level on neuron synchronization . Recordings with micro-ECoG grid electrodes in the cortex show improved spatial resolution and these will be used to gain better understanding of cortical network dynamics and the synchronization with subcortical structures.

The purpose of the study is to evaluate the safety and tolerability after administration of multiple doses and the pharmacokinetics (PK) of single and multiple doses of UCB0599 in healthy study participants and participants with Parkinson's Disease (PD).

Non-pharmacological therapies become more important in the management of Parkinson's disease (PD). Among these, mindfulness meditation is the subject of high expectations. This intervention, such as the Mindfulness-Based Stress Reduction-based (MBSR) stress reduction program, have shown effects on psychological distress, motor and non-motor disorders, and quality of life. However, the data is still very frail and the conditions for practical use are still very uncertain. The objective of the study is to determine the feasibility of a standardized MBSR program in Parkinsonians patients.

Treatment of sleep disturbances is mainly attempted through drug administration. However, certain drugs are associated with unwanted side effects or residual effects upon awakening (e.g. sleepiness, ataxia) which can increase the risks of falls and fractures. In addition, there can be systemic consequences of long-term use. An alternative method of manipulating sleep is by stimulating the brain to influence the electroencephalogram (EEG). To date, there have been mixed results from stimulating superficial areas of the brain and, as far as we know, there has been no systematic attempt to influence deep brain activity. Many patients suffering from movement disorders, such as Parkinson's Disease (PD) and Multiple Systems Atrophy (MSA), also have disrupted sleep. Currently, at stages where drug treatment no longer offers adequate control of their motor symptoms, these patients are implanted with a deep brain stimulation system. This involves depth electrodes which deliver constant pulse stimulation to the targeted area. A similar system is used in patients with severe epilepsy, as well as some patients with chronic pain. The aim of this feasibility study is to investigate whether we can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep. We will only use stimulation frequencies that have been proven to be safe for patients and frequently used for clinical treatment of their disorder. We will examine the structure and quality of sleep as well as how alert patients are when they wake up, while also monitoring physiological markers such as heart rate and blood pressure. Upon awakening, we will ask the patients to provide their subjective opinion of their sleep and complete some simple tests to see how alert they are compared to baseline condition which would be either stimulation at the standard clinical setting or no stimulation. We hope that our study will open new ways of optimising sleep without the use of drugs, in patients who are implanted with depth electrodes. We also believe that our findings will broaden the understanding of how the activity of deep brain areas influences sleep and alertness.

The study is an open-label trial to validate the local field potential (LFP) activity in the subthalamic nucleus (STN) for slow-wave detection during acoustic stimulation during nighttime sleep in Parkinson's disease patients that receive deep-brain-stimulation (DBS) therapy with the novel PERCEPT™ DBS system.