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Parkinson Disease clinical trials

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NCT ID: NCT02611713 Completed - Clinical trials for Advanced Parkinson's Disease

Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease

DUOGLOBE
Start date: January 4, 2016
Phase:
Study type: Observational

This study is a non-interventional post-marketing observational study (PMOS) of participants with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical setting. Effectiveness of treatment will be collected with physician and participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6 months thereafter up to 36 months. An additional cohort of participants will be enrolled who in addition will be evaluated with a wearable device.

NCT ID: NCT02611167 Completed - Parkinson's Disease Clinical Trials

Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's Disease

Start date: November 1, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, feasibility, and efficacy of intravenous allogeneic bone marrow-derived mesenchymal stem cell (MSC) therapy for idiopathic Parkinson's disease (iPD).

NCT ID: NCT02610634 Completed - Parkinson's Disease Clinical Trials

Visual Function During Gait in Parkinson's Disease: Impact of Cognition and Response to Visual Cues

Start date: July 2013
Phase: N/A
Study type: Observational

Parkinson's disease (PD) is associated with problems of gait such as veering, difficulty turning, an inability to perceive doorways or obstacles, and negotiate uneven terrain. Gait problems, especially veering, may be exacerbated by visuospatial dysfunction which predispose to falls, freezing and festination of gait. Visuospatial dysfunction is common in PD and likely involves peripheral features (e.g. contrast sensitivity) as well as central cognitive mechanisms (e.g. attention). Central neuro-degeneration in PD, PD dementia, and dementia with Lewy Bodies may influence visual function, as impaired visual sampling has been reported in these conditions. Visual sampling is measured via saccadic (fast eye movement) activity, as saccades are the mechanisms through which people orientate and explore the environment. The use of objective devices to reliably measure saccades is important to detect disease related eye movement changes. Emerging visuomotor research has measured visual sampling in PD using devices such as electrooculography and infra-red eye tracking, revealing reduced amplitude, speed and frequency of saccades during various tasks. Despite recent increases in visuomotor research it remains unclear how PD influences visual sampling of the environment during gait and the influence of attentional and cognitive deficits. Recent work demonstrated that people with PD sample their environment less frequently than controls, despite a slower gait. Saccadic timing was unchanged in response to environmental cues. Despite this, environmental visual cues (transverse lines on the floor) have been shown to increase the number of fixations made during gait. However the mechanisms of this response remain unclear. Cognition is likely of importance, with response potentially influenced by attentional control. This observational study aims to examine the influence of cognition on visuomotor control during gait in PD. This aim will be achieved by observation of visual sampling under several environmental challenges (straight walk, doorways, turns, visual cue) and a dual task.

NCT ID: NCT02610257 Completed - Parkinson's Disease Clinical Trials

Somatosensory Dysfunction as the Underlying Mechanism of Upper Limbs Motor Blocks in People With Parkinson's Disease

Start date: January 2016
Phase: N/A
Study type: Interventional

Motor blocks during gait and upper limb movements (FOULs) are a disabling and common motor impairment in mild to severe stages of Parkinson's disease (PD). However, the main mechanism underlying these phenomena is still an open debate. Apart from the motor correlates, cognitive-attentional impairment and somatosensory deficits (especially in the proprioceptive system) may underlie these motor blocks. The current study aims to unravel whether the proprioceptive system is involved by manipulating task-relevant or non-relevant proprioceptive stimuli. Hence, the main aims of this study are: (i) to assess the somatosensory function in people with PD that experience freezing of gait FOG and (ii) to investigate the effects of manipulating both proprioception and attentional resources on FOUL severity. Forty-five people will be assigned to three age-matched groups (N=15 each): healthy elderly, PD patients that experience FOG (FOG+) and PD patients that do not experience FOG. Cutaneous sensory function and kinesthetic ability will be assessed by means of standardized user-friendly methods and precise repositioning measures using the VICON motion analysis. Additionally, participants will perform a newly developed task that can successfully elicit FOULs (a handwriting freezing-provoking task) on a custom tablet (Heremans et al 2015). The task will be performed without and with the use of muscle vibration (a well-known method to stimulate the proprioceptive system). The investigators will manipulate both the timing of vibration (relevant - after FOUL onset; or non-relevant: before FOUL onset) and the region of stimulation (neutral: on a bone-mark where there is little if any proprioceptive stimulation; and on a non-neutral spot: on the forearm muscles). It is believed that FOG+ will present with worse somatosensory function than those who do not experience motor blocks (especially in the proprioceptive system). Additionally, the Investigators expect a reduction in FOUL severity (e.g. FOUL duration) when vibration is applied in a task-relevant way, independently of the region stimulated. In contrast, it is also expected that when vibration is applied in a non-relevant way and it may act as a distractor, FOUL duration will increase. This study will thus be able to distinguish between the contribution of attentional and proprioceptive resources to the mechanism of motor blocks in PD.

NCT ID: NCT02610231 Completed - Clinical trials for Idiopathic Parkinson's Disease

Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

Start date: December 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination (levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for eligibility for the study. Eligible subjects will be treated with istradefylline at a starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on the Investigator's judgment of each subject's response and tolerability. If deemed necessary, one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment visit if there are tolerability issues. The istradefylline dose should remain fixed between Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any unscheduled dose adjustment visits. A subject may discontinue from the study at any time.

NCT ID: NCT02608424 Completed - Hypertension Clinical Trials

Effects of Feet Mechanical Stimulation on Cardiovascular Autonomic Profile and Inflammation in Parkinson's Disease

parkgo-1
Start date: March 2015
Phase: N/A
Study type: Interventional

In the present study, investigators test the hypothesis that a controlled mechanical pressure applied on specific sites of both fore-feet (ES) can reduce the inflammatory state and arterial blood pressure in patients with Parkinson's Disease by increasing the overall parasympathetic activity and reducing vascular sympathetic modulation.

NCT ID: NCT02605161 Completed - Parkinson's Disease Clinical Trials

Imaging Blood Brain Imaging Dysfunction in Parkinson's Disease

Start date: November 2015
Phase:
Study type: Observational

The purpose of this study is to evaluate the blood brain barrier in the striatum of patients that have other types of movement disorders compared to patients with Parkinson's Disease that are receiving similar treatment, to determine if a there is a disruption of the blood brain barrier in patients with Parkinson's Disease.

NCT ID: NCT02604914 Completed - Parkinson's Disease Clinical Trials

A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects

Start date: May 29, 2015
Phase: Phase 1
Study type: Interventional

An Open-Label Study in Healthy Male and Female Subjects to Identify the Concentration that Provides Optimal Bioavailability of Levodopa Infused Subcutaneously via a Pump System; and to Compare the Bioavailability of Levodopa/Carbidopa Solution to that of Levodopa/Carbidopa Intestinal Gel (LCIG), Infused via a Naso-Jejunal Tube

NCT ID: NCT02601586 Completed - Parkinson Disease Clinical Trials

Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease

OXYDOPA
Start date: September 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study will be conducted in three parallel groups receiving oxycodone, levodopa or placebo, administered as an add-on therapy, in addition to the usual antiparkinsonian treatment. As this study focuses on chronic central neuropathic pain caused by PD, the effects of study treatments will be evaluated after a 10-week treatment period

NCT ID: NCT02601144 Completed - Parkinson's Disease Clinical Trials

Variable Frequency Stimulation of Subthalamic Nucleus for Freezing of Gait in Parkinson's Disease

Start date: October 2015
Phase: Phase 1
Study type: Interventional

This is the first study on the effect of the variable frequency stimulation (VFS) on Freezing of gait (FOG) in Parkinson's disease (PD) patients with STN DBS. FOG has responded poorly to High frequency stimulation (HFS) but can be alleviated by relatively VFS. This study would have significant clinical implications in the management of Freezing of gait (FOG) in these PD patients with subthalamic nucleus (STN) DBS. The investigators hypothesize that VFS could have better effect on FOG than HFS and low frequency stimulation (LFS).