Active clinical trials for "Parkinson Disease"

Study J3Z-MC-OJAA is a Phase 1/2a, multicenter, open-label, ascending dose, first in-human study that will evaluate the safety of intracisternal LY3884961 administration in patients with moderate to severe Parkinson's disease with at least 1 pathogenic GBA1 mutation. Two dose level cohorts of LY3884961 are planned (Dose Level 1 and Dose Level 2). The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of LY3884961 on safety, tolerability, immunogenicity, biomarkers, and clinical efficacy measures. Patients will continue to be followed for an additional 4 years to continue to monitor safety as well as selected biomarker and efficacy measures.

Pre-Active PD is a randomized controlled feasibility study to evaluate the implementation of a telehealth-delivered physical activity behavior change intervention for people with early-mid stage Parkinson's disease. The program utilizes occupational therapists to provide one-to-one individualized support to facilitate and optimize exercise uptake as part of their disease self-management. The structure of the intervention is based on previous research in neurodegenerative disease including Parkinson's disease and Huntington's disease.

The ability to walk independently is a primary goal when rehabilitating an individual with Parkinson Disease (PD). Indeed, PD patients display a flexed posture that coupled with an excessive joint stiffness lead to a poor walking mechanics that increase their risk of falls. Although studies have already shown the many benefits of robotic-assisted gait training in PD patients, research focusing on optimal rehabilitation methods has been directed towards powered lower-limb exoskeleton. Combining the advantages delivered from the grounded devices with the ability to train in a real-world environment, these systems provide a greater level of subject participation and increase subject's functional abilities while the wearable robotic system guarantees less support. The purpose of the present work is to evaluate the effects of an Over-ground Wearable Exoskeleton Training (OWET) on gait impairments in comparison with a multidisciplinary intensive rehabilitation treatment. As gait is a complex task that involves both central (CNS) and peripheral nervous systems (PNS), targeted rehabilitation must restore not only gait mechanics (ST parameters) but also physiological gait pattern (joint kinematics and dynamics). To this aim the impact of OWET on both CNS and PNS will be evaluated. Thus, a quantitative assessment of an individual's gait and neuromuscular function to robustly evaluate recovery of altered sensorimotor function at both the PNS and CNS is proposed. To this aim, comprehensive GA (spatiotemporal (ST) parameter, joint kinematics, joint stiffness) and electromyography (EMG) will be combined to determine PNS improvements, and fMRI with EEG will be used to assess CNS improvements.

Introduction: Parkinson's disease (PD) is the second most common neurodegenerative disease in the elderly. Chronic and progressive, it includes loss of dopamine, a neurotransmitter involved in the regulation of movement. Thus, functional changes, such as postural disorders, trunk flexor pattern, muscle activation deficits, impairment of gait, balance, and mobility are common findings in this population. Once there is dopaminergic depletion, it is important to identify mechanisms that act in the production and survival of nigral dopaminergic neurons, like the brain-derived neurotrophic factor (BDNF). Studies describe a correlation between serum BDNF levels and PD motor dysfunction. Still, it is presumed that physical therapy can positively regulate substances that act directly on the Central Nervous System, such as BDNF. Physical exercise, in addition to promoting biochemical modulations in PD, can provide benefits in motor symptoms that sometimes do not improve with drugs. Conventional physiotherapy performed on dry land is a therapeutic resource used in PD. The conventional physiotherapy is useful for management of functional changes caused by PD due to muscle strengthening exercises. These exercises can be adapted and performed in water, at different depths, shallow and deep water. Thus, aquatic physiotherapy has been shown to be able to interfere in PD motor disorders, with perspective of maximizing the rehabilitation program effects due to the physical properties of water. These reasons, in addition to the large use of these interventions in the clinical practice and their likely benefits in the PD alterations, suggest the importance of studies in this area. Furthermore, the immediate effects of strengthening interventions with global extensor musculature emphasis on global extensor musculature, and of high-intensity training protocols, which encompass different environments and different depths, on functional and biochemical measures of PD are poorly studied. Objectives: To verify the acute effects of a global extensor musculature strength training protocol, performed on dry land and shallow water, and of a high-intensity training protocol performed in shallow and deep water on functional and biochemical measurements of individuals with PD. Methods: This will be a single-blind crossover, cross-sectional study with a 24-hour follow-up. The sample will be composed of subjects between 50 and 70 years old, classified from 1 to 3 in the Hoehn and Yahr scale, with a PD diagnosis rigid-akinetic and/or tremor-dominant type in the "OFF" period of the medication. In this research there will be an intervention group (IG) composed of individuals with Parkinson's disease and a control group (CG) of healthy individuals. Both will be randomly distributed in a randomized way and submitted to two different training sessions, for 60 minutes, at different times, in order to analyze the acute effects and follow-up of the following interventions: a strength training of the global extensor musculature in dry land and shallow water (120 cm deep) and high-intensity training (Borg Scale), at different depths: shallow water (120 cm deep) and deep water. To characterize the sample, anamnesis and Motor Examination of Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS III) will be performed. The individuals will be submitted to pre, post and 24h evaluations after the intervention. Functional measures will be analyzed: postural stability, by stabilometry; strength, by isokinetic dynamometry; spatiotemporal gait variables, with kinematic analysis; balance, with Berg Balance Scale and functional mobility with Timed Up and Go test and biochemical analysis: venous blood collection and ELISA test will be performed measuring serum BDNF levels. In this way, the acute effects of the global extensor musculature strength training protocol and of high-intensity training on the different variables analyzed, environments, depths and moments of evaluation will be analyzed and compared.

Background: Parkinson's disease (PD) is a prevalent and debilitating condition. Conventional medications cannot control all symptoms and may inflict adverse effects. A survey reported that Chinese herbal medicine (CHM) is frequently sought. Existing CHM trials were contradictory and often of poor quality due to a lack of methodological rigor. A national clinical guideline was drafted in China with diagnostic criteria and treatment strategy of Chinese medicine (CM) patterns subgroups of PD. The suggested CHM was found to exhibit a neuroprotective effect in in vitro and in vivo studies. This trial aims to preliminarily assess the effect of CHM prescribed based on pattern differentiation on PD symptoms and patients' quality of life, and evaluate the feasibility of the trial design for a future large-scale trial. Methods: This trial will be a pilot assessor- and data analyst blind, add-on, randomised, controlled, pragmatic clinical trial. 160 PD patients will be recruited and randomised into treatment or control groups in a 1:1 ratio. The trial will be conducted over 32 weeks. PD patients in the treatment group will be stratified into subgroups based on CM pattern and receive CHM accordingly in addition to conventional medication (ConM). The control group will receive ConM only. The primary outcome will be part II of the Movement Disorder Society Sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Secondary outcomes will include part and total scores of MDS-UPDRS, domain and total scores of Non-motor symptom scale (NMSS). Adverse events will be monitored by monthly follow-ups and questionnaires. Mixed models will be used to analyse data by Jamovi and R. Expected outcomes: The success of our trial will show that the pragmatic design with subgroup differentiation is feasible and can produce reliable results. It will also provide preliminary data of the effect of CHM on improving clinical outcomes and quality of PD patients. Data collected will be used to optimize the study design of the future large-scale clinical study. Ethical clearance: Ethical clearance of this study was given by the Research Ethics Committee of Hong Kong Baptist University (REC/20-21/0206).

The purpose of this study is to investigate the brain activity associated with non-motor symptoms of movement disorders, including Parkinson's disease and essential tremor. These movement disorders commonly have significant non-motor features also, including depression, cognitive impairment, decreased attention, and slower processing speeds. The investigators are interested in the brain activity associated with these symptoms, and perform recordings of the surface of the brain, in addition to the typical recordings the investigators perform, during routine deep brain stimulation (DBS) surgery.

Patients with atypical parkinsonism often show gait and mobility impairment manifesting in early disease stages. In order to maintain mobility and physical autonomy as long as possible for these patients, we will examine the effect of two types of physiotherapy in patients with multiple system atrophy (MSA), progressive supranuclear gaze palsy (PSP) and idiopathic Parkinson's disease (IPD). The study is divided into an ambulant daily in-patient physiotherapy phase, followed by a home-based training phase. At the beginning and the end of the study, the patients daily activity will be recorded for one week using Physical Activity Monitoring (PAM) sensors. The aim of this double-blind, randomized-controlled study is to determine effective physiotherapy in patients with atypical parkinsonian syndromes in order to maintain mobility for as long as possible.

The goal of this intervention is to explore the effectiveness of a Turning Intervention (TURN-IT) to improve quality of turning in participants with Parkinson's Disease (PD). An unique exercise program has been developed - TURN-IT - in which participants practice exercises that focus on physiological constraints that impair turning ability, such as axial rigidity, narrow base of support, bradykinesia, and inflexible set-shifting. The 60 participants with PD and a history of falls in the previous 12 months, will be randomized into a 6-week, 3x/week, one-on-one TURN-IT group or No-Intervention Control group. This pilot intervention study will determine the number of subjects needed for a future clinical trial and will determine the sensitivity to change with rehabilitation our daily-life turning quality measures (such as, mean and variability of number of steps to turn, turn amplitude, turn velocity). The investigators predict that the TURN-IT program will improve turning in daily life enough to justify a larger clinical trial.

Parkinson's disease (PD) is characterized by many non-motor symptoms that occur several years before the diagnosis, in particular idiopathic REM behavior disorder (iRBD), which is associated with autonomic impairment. The purpose of this study is to investigate the effect of treatment with the selective post-synaptic a1-adrenergic blocker terazosin on 123I-MIBG myocardial uptake in a population of subjects with defined pre-motor PD risks (i.e. hyposmia and RBD) and abnormal baseline 123I-MIBG uptake, with or without 123I-Ioflupane uptake abnormality or PD motor symptoms. Scintigraphic changes will be correlated to motor and non-motor severity of PD, measured by validated clinical scales and cardiac autonomic function tests.

Introduction: Parkinson's Disease (PD) is characterized as a neurodegenerative disorder associated with the progressive loss of dopamine in the basal ganglia region, resulting in classic motor symptoms such as bradykinesia, rigidity, postural instability and tremor. Such symptoms end up affecting the functionality of the upper limbs (ULM) in this population. In recent years, therapy based on Virtual Reality (VR) has been gaining popularity, but studies in the area are still lacking. Objective: To verify the benefits of immersive and non-immersive virtual reality in the functionality of the upper limbs in individuals with PD, and to identify possible differences between them. Methodology: This is a randomized clinical trial, in which the evaluators will be separate from the experimental groups (single-blind). Subjects with PD will be randomized into two groups: Immersive group (IVR), which will receive treatment with virtual reality games in an immersive environment through Leap Motion Controller (LMC) devices together with image projection on a Head-mounted -display (Oculus Quest) and the non-immersive group (RVnI) in which they will receive treatment with the CML on a flat screen. Both treatments will focus on broad and fine upper limb tasks, in a protocol with 4 activities and duration of 27 minutes, twice a week, for eight weeks. The two groups will be evaluated in three moments: before the intervention, immediately after 8 weeks and 60 days after the end of the interventions. They will be analyzed in terms of ADLs, through the TEMPA test and part II of the unified assessment of PD (MDS-UPDRS II); motor assessment (part III) of the MDS-UPDRS and motor staging of PD (Hoehn & Yahr); manual dexterity through the Box and Block test and through the Nine Hole Peg Test; cognition by Montreal Cognitive Assessment (MoCA); quality of life through the PD questionnaire (PDQ-39); the usability of the system (SUS); and possible side effects (Simulator Sickness Questionnaire). This study is expected to show that treatment with immersive VR has greater positive effects than non-immersive VR on the functionality of the upper limbs of individuals with PD.