Active clinical trials for "Parkinson Disease"

This is multicentre, proof of concept, randomized, double-blind, parallel-group, placebo-control study in 40 Parkinson's Disease (PD) patients. Patients will be randomized in 2 groups receiving Bumetanide or placebo for 4 months: Group 1 (20 PD patients): bumetanide Group 2 (20 PD patients): placebo intake identically to group 1.

The main objective of this study is to evaluate whether people whose PD symptoms are uncontrolled who are managed with the aid of objective measurement and use of target ranges have improved PD symptoms and outcomes as compared to individuals treated using only standard of care (medical history, neurological examination).

The objective of this study is the longitudinal prospective clinical evaluation in patients with motor predominant PD; it will assess the individual disease progression (change) of the clinical and imaging parameters measured at 6-month interval over a minimum of 12 months.

Parkinson's disease (PD), one of the most common neurological disorders, affects at least 10 million people worldwide. The cardinal motor impairments are tremor, bradykinesia, muscle rigidity, and postural instability. While dopaminergic medication and surgical treatment have been shown to suppress tremor, bradykinesia, and muscle rigidity, they do not prevent the progression of the disease or effectively treat postural instability. The latter impairment, which often leads to frequent falls, substantially restricts motor performance and daily activities. PD is commonly managed in outpatient neurology or movement disorder clinics. Clinical studies have shown that physical and balance rehabilitation regimens supervised by physical therapists can improve postural stability in people with PD for short (hours to days) and long (weeks to months) periods. Cost, limited availability of physical therapists, etc., however, often prohibit many people with PD from undertaking such regimens. Evidence is mounting that periodic and continuous exercising is important for people with PD who are under care at home. Nevertheless, when given a rehabilitation regimen to practice at home, compliance (i.e., adherence) and engagement generally decrease in the absence of real-time therapeutic feedback. The PI has developed a smartphone-based, wearable balance rehabilitation system, known as the Smarter Balance System (SBS), which supplies real-time feedback to people with PD practicing balance rehabilitation regimens at home. The objectives of this study are to assess and compare the results of long-term rehabilitative balance training for people with PD performing in-home balance training regimens with assistive guidance via the SBS (intervention group) to people following a typical paper-based regimen (control group). The carry-over effects of long-term rehabilitative training by the intervention group and the control group on static/dynamic balance performance, daily activities, and confidence in less fear of falling are analyzed quantitatively and qualitatively.

To determine the effectiveness of group therapy along with transcranial direct current (tDCS) stimulation on motor symptoms, balance and quality of life in patients with Parkinson's disease(PD). 128 patient with PD will be recruited by the cluster sampling method for the two group pretest-posttest randomized controlled trial. The patient with PD will be allocated in two groups, Group therapy only (GTO) group and Group therapy with tDCS (GT-tDCS) treatment group by block randomization technique. Both GTO group and GT-tDCS group will receive the structured group therapy programme for one hour duration, twice a week for 6-weeks. In addition to the structured group therapy programme, GT-tDCS group will receive 20 minutes of tDCS application once a week for the 6-week duration. Data will be analysed at baseline, 3 weeks and 6 weeks of post intervention.

Freezing of gait (FoG) is defined as a brief, episodic absence or reduction of forward progression of the feet despite the intention to walk. It is one of the most disabling and intractable motor symptoms in patients with Parkinson's disease (PD) as it often causes falls and loss of independence. The pathophysiology of FoG remains unclear but it seems differ from other cardinal motor symptoms in PD. The therapeutic efficacy of medical and surgical treatments for FoG are usually suboptimal. Deep brain stimulation (DBS) in the subthalamic nucleus (STN) is a well established treatment for advanced PD with motor fluctuation. It alleviates tremor, bradykinesia and rigidity and improved the quality of life. However, the therapeutic effects of DBS are impeded by high cost of device, stimulation induced adverse effects and partial treatment for some parkinsonism symptoms, particular gait disturbance and FoG. Recently, a new mode of stimulation is proposed. Differing from the conventional DBS which is operated in open loop so that stimulation remains fixed over time and is delivered at regular and high frequencies, the new adaptive DBS (aDBS) detects the pathological activities and only deliver stimulation when it is necessary. Recent studies in MPTP-primate and patients with PD demonstrate that the aDBS is superior to standard continuous DBS. However, the therapeutic efficacy is only shown in "appendicular symptoms" such as bradykinesia, rigidity and tremor. There is no report about the effect of aDBS on gait disturbance, particular FoG in PD so far. The aim of the current project is to test whether the therapeutic efficacy of aDBS is superior to conventional DBS in PD patients with FoG. To this end, 20 advanced PD patients who undergo STN DBS implantation for the treatment of their disorders will be examined. The gait of patients will be assessed during conventional open loop stimulation and aDBS and the therapeutic efficacy for FoG will be defined. The results of this study will also contribute to better understanding of pathophysiology of FoG and to future development of embedded aDBS system for PD.

There are experimental evidences of the important role of high intensity physical exercise in Parkinson's disease (PD) treatment, that induces similar effects to pharmacotherapy. So far, the mechanisms of the impact of these changes on the brain subcortical and cortical regions functioning, motor activities and cognitive functions are still not clear. The aim of this longitudinal (prospective) human experiment is to examine the effects of two cycles of 12-weeks high-intensity interval training (HIIT) on: (i) the level of dopamine (DA) in putamen in striatum, (ii) neurophysiological function of subcortical and cortical motor structures and skeletal muscle activity, (iii) psychomotor behaviors critically associated with dopamine dependent neural structures functioning and (iv) neurotrophic factors' secretion level in blood. The investigators will recruit 40 PD individuals, who will be divided into two groups: one of them will perform two 12-weeks cycles of HIIT (PD-TR), and the other will not be trained (PD-NTR) with HIIT. The investigators will also recruit 20 age-matched healthy controls (H-CO) as additional control group who will not perform the HIIT. The PD-TR group will perform the two 12-weeks cycles of the HIIT, that induces beneficial, neuroplastic changes and alleviates the PD symptoms, what was found in earlier studies. All PD subjects (PD-TR and PD-NTR) will be examined during their medication "OFF-phase" (it means after dopaminergic drugs withdrawal) before (Pre) and after (Post) training cycles (first training cycle - HIIT 1; second training cycle - HIIT 2), and namely: Pre HIIT 1, 1 week-, 1.5 month- and 3 months-Post HIIT 1; and then similarly 1 week-, 1.5 month- and 3 months-Post HIIT 2. The subject from H-CO will be tested only once. To examine the assumed HIIT-induced changes in brain functioning the investigators will apply: (i) the positron emission tomography (PET), (ii) the functional magnetic resonance imaging (fMRI), (iii) electroencephalography (EEG) and (iv) an analysis of neurotrophic factors secretion level in blood. The investigators will also assess motor and non-motor symptoms of PD and psychomotor behaviors based on neuropsychological tests of cognitive functions and manual dexterity. The results of this project will help to answer the fundamental questions about HIIT induced mechanisms of neuroplasticity in PD patients, what is important from scientific and treatment-strategy point of view.

This will be a Phase II single center, double-blind, randomized, placebo-controlled, efficacy study. Subjects will complete six visits. The first will be a screening visit. There will be four assessment visits: baseline, 2 weeks after the double-blinded trial begins, the end of the blinded trial, and after 4 weeks of washout. There will also be an additional randomization and medication dispensing visit immediately following the dose optimization period and preceding the double-blinded trial.

In order to find the most effective rehabilitative therapies for Parkinsonian patients, the present study is aimed to evaluate whether, in a multidisciplinary intensive rehabilitation treatment, the dance therapy, applied to the motor learning, promote additional benefits.

The purpose of this study is to assess the PK of AP-CD/LD given at dose of 50/500mg three times daily compared to CD/LD immediate release (Sinemet) 1.5 tablets of dose of 25/100 given 5 times per day in Parkinson's Disease patients.