Active clinical trials for "Parkinson Disease"

The aim of this application is to compare and elucidate the effects of skill-based versus aerobic exercise versus control on mild cognitive impairment (MCI) of the executive function (EF) subtype in Parkinson's disease (PD); we hypothesize that skill-based exercise will result in the greatest improvement in EF and lead to modification of underlying neural substrates.

This is an an open label clinical trial of sustained-release Melatonin 2mg once daily for 12 weeks in patients with Parkinsons's Disease reporting nocturia, defined as getting up regularly at night > twice to pass urine. The primary objective of this study is to evaluate the effects of exogenous melatonin on bother related to nocturia. Secondary objectives are to evaluate: 1) Mean night time urinary frequency 2)Volume of urine voided at night 3)Incontinence and other lower urinary tract symptoms (LUTS) 3)Quality of sleep 4) Quality of life 5) Sleep disturbance of partners 6)Safety

Deep Brain Stimulation (DBS) of the Subthalamic nucleus (STN) is an established treatment for patients with advanced Parkinson's disease (PD). STN DBS improves dopaminergic drug-responsive motor symptoms, thus allowing a reduction of post-operative drug dose. However, a considerable variation in the extent of dopaminergic drug reduction has been reported, with values ranging from 20% to 100%. Both L-dopa and DAs can be used, however, there are no formal studies examining which type of antiparkinsonian medication may be more effective and/or better tolerated following STN DBS. Aim of our study is to compare the efficacy and the tolerability of L-dopa monotherapy versus DAs monotherapy after STN DBS over a 3-month follow up period. This study is a prospective, single blind parallel trial comparing L-dopa monotherapy and DAs monotherapy after STN DBS. Patients will be enrolled in pairs, with one patient randomly assigned to L-dopa monotherapy and the other to DA monotherapy after STN DBS (20 patients for each study arm). Treatment assignment will be unmasked for the patient but will be blinded for the neurologist programming DBS and evaluating the patient. Another neurologist will be in charge of medication adjustments. Primary outcome is the change in severity of non-motor symptoms as assessed by the Non-motor Symptoms Scale (NMSS) at 3-month follow up visit after surgery. In spite of an improvement of the motor condition many patients develop apathy and depression following surgery ("Neurosurgery in Parkinson's disease: the doctor is happy, the patient less so"). This study will shed light on the best way to manage patients after STN procedure, thus contributing to a further improvement of the surgical outcome in a population of young and motivated patients (those commonly receiving STN DBS), eventually bringing them closer to a normal personal and social life. Results of our study may provide new insights in the management of advanced PD after STN DBS, further leading to development of future larger trials.

Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past research indicated that more than half of the individuals with PD demonstrated fatigue symptom. The severity of fatigue was also correlated to the quality of life in individuals with PD. Finding the contributions of the central and the peripheral factors to fatigue and developing an effective training program for individuals with PD are very important. Fatigue can be categorized into peripheral or central causes. The central fatigue and voluntary activation failure originate from the decrease in motivation or the reduction of the conduction within corticospinal tracts. Long term activation failure and central fatigue will cause disuse of muscle and result in peripheral weakness and peripheral fatigue. Quantifying the weighting of central versus peripheral factors contributing to the fatigue in people with PD is important. Most of the conventional strength and endurance training programs were based on the researches of young groups. Almost no training program was design for enhancing the voluntary activation level and relief the central fatigue. Seeking an appropriate training program to enhance central activation is very important for individuals with PD who prone to fatigue. Previous studies have shown that increasing afferent input by peripheral electrical stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary sensory cortex, the excitability of corticospinal tracts, and the functional performance in young adults. Combining afferent input with strength training was more effective than strength training along. ES, which is easy to quantify the dose of afferent input, is a feasible method to provide such training. The purpose of this project is to investigate the effects of the combination of ES at sensory threshold and strength training on voluntary activation in the individuals with PD.

Despite its therapeutic effectiveness in Parkinson's disease (PD) the current deep brain stimulation (DBS) strategy could achieve an even better clinical result by adapting to patient's condition. As intracerebral activity analyzed by recording local field potentials (LFPs) from DBS electrodes correlates to PD symptoms, a new stimulation approach would be an "intelligent" adaptive DBS system able to change stimulation settings automatically to the patient's needs using LFPs as control variable.

The aim of this study is the development and implementation of a new protocol of a physical therapy training, based on a gait training associated with executive tasks, for treatment of individuals with Parkinson's Disease. The hypothesis is that this group of patients who will carry out training of this study protocol will show improvement in measured parameters (functionality of gait and cognitive ability), which allows this protocol to be improved and published as a proposal of physiotherapeutic treatment.

Gait initiation (GI) difficulty is common in people with Parkinson's disease (PD). Studies showed that the GI difficulty was related to impaired anticipatory postural adjustments (APA). In healthy people, two phases of APA related center of pressure (COP) shifting were observed before GI. In people with PD, delay and decrease amplitude of APA or abnormal multiple APAs were observed during GI. Conventional balance tests record the maximum displacement and/or velocity of Center of pressure (COP). However, these variables could not show the performance of APA. Previous studies suggested that balance and gait initiation were controlled by separate neural circuitries. This could explain why the conventional COP measurement did not correlate to GI very well. It is important to develop GI related APA tests and trainings. Researchers found that a perturbation applied before the COP displacement during GI could delay both GI and APA. This indicates that COP displacement has APA components. Our pilot study shows that there is a reverse direction of COP displacement before voluntary COP displacement, suggesting the existence of APA. This three year project will evaluate the relationship of the APA of voluntary COP displacement and the APA of GI, establish the APA test for PD, and investigate the effect of APA training on GI in people with PD. In the first year, 20 people without disability will be recruited. The APA before voluntary COP displacement test, APA before GI, and gait performance will be evaluated. In the second year, 15 people with PD and 15 healthy people will be recruited. Subjects will receive GI test, gait test, and APA before voluntary COP displacement test. The relationship between different types of APA will be established for PD and healthy people. In the third year, 30 people with PD will be randomized into APA training group, balance group, and control group. The different training effect will be evaluated especially on GI, gait performance, and freezing of gait. This project will advance the knowledge of mechanism of GI difficulty. The result of this project can be applied to clinical rehabilitation of people with GI difficulty.

The purpose of this study is to determine whether the gastric retentive Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's Disease patients.

this study is aimed to evaluate the effectiveness of an Multidisciplinary Intensive Rehabilitation Treatment in Advanced Stages of Parkinson's Disease. In the last years, several evidences highlighted the need of a multidisciplinary and intensive approach to achieve good results in early stage of disease. Hypothesis is that this approach is effectiveness also in moderate and advanced stages of disease

In order to observe the benefit, side effects, and patient preference of Mirapex ER when used in once-daily (QD) or twice-daily (BID) dosing In order to estimate the conversion rate of dopamine agonists into Mirapex ER