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Parkinson Disease clinical trials

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NCT ID: NCT05514379 Enrolling by invitation - Parkinson Disease Clinical Trials

Effect of Cognitive Training on Gait in Parkinson's Disease

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Physiotherapy and targeted rehabilitation are routinely performed in order to influence disorders of posture, gait and stability in Parkinson´s disease (PD), but their effects have been controversial (Keus et al. 2014; Walton wt al. 2014). Recently, several studies suggested that cognitive training can improve gait in patients with PD (Peterson et al. 2016, Heremans et al. 2013), similar to the effects seen in the elderly (Yogev-Seligmann et al. 2008; Amboni et al. 2013). Specific training programs including dual tasking with automatic verbal series, counting etc. have led to increased walking speed and improved stepping cadence, length, and duration in patients with dementia (Schwenk et al. 2010). However, since in advanced PD patients dual-task gait training has to be supervised by therapists, it is not a suitable type of therapy to be performed at home. Therefore, this study aims to verify and extend the encouraging results of the single study which showed a positive effect of cognitive function training on gait in PD (Milman et al. 2014) by exploring this effect in advanced PD patients, by assessing the effect on gait using more targeted clinical and instrumental evaluation, and by comparing two modes of therapy delivery, group and computer-based.

NCT ID: NCT05511597 Enrolling by invitation - Parkinson Disease Clinical Trials

Split-belt Treadmill Training for Freezing of Gait in Parkinson's Disease

SBT FOG-TRAIN
Start date: December 16, 2022
Phase: N/A
Study type: Interventional

A split-belt treadmill (SBT) is a treadmill with two belts, whereby each leg can be driven at a different speed. Previous work by the investigators showed that one session of SBT training improved turning while multi-tasking and reduced FOG in PwPD tested in the laboratory. However, subsequent work raises questions as to whether treadmill improvements following repeated SBT training generalize to overground situations in the long term. Therefore, in this study, the investigators will perform a four-week SBT intervention with added practice of everyday turning scenarios (SBT+CP) or placebo exercise (SBT+PL), and study its effects on FOG in both the laboratory and at home.

NCT ID: NCT05504902 Enrolling by invitation - Parkinson Disease Clinical Trials

Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease

Start date: August 30, 2023
Phase: N/A
Study type: Interventional

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on advanced stage Parkinson's symptoms. VCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. Patients will be followed for two years.

NCT ID: NCT05450237 Enrolling by invitation - Stroke Clinical Trials

Psychometric Evaluation in Patients With Brain Damage During Neuroinflammation (NeuroPsyc)

NeuroPsyc
Start date: May 18, 2022
Phase:
Study type: Observational [Patient Registry]

The presence of a damage to the central and / or peripheral nervous system resulting from diseases of a different nature (such as, Multiple Sclerosis, Parkinson's disease, dementia, head trauma, stroke, epilepsy or other neurological syndromes) is commonly cause of both physical than mental disability. The evaluation of certain domains may be more difficult so, specific assessment tools are necessary to analyze them.

NCT ID: NCT05319795 Enrolling by invitation - Parkinson Disease Clinical Trials

Effortful Swallow Maneuver for Swallowing Impairment in People With Parkinson Disease

Start date: March 9, 2022
Phase: N/A
Study type: Interventional

Context: Many people with Parkinson Disease (PwPD) experience swallowing difficulties, particularly with food/liquid going down the wrong way or remaining in the throat after swallowing. Prior studies suggest that exercise-based treatments targeting swallowing strength may be effective in reducing these difficulties. Research question: Does an exercise-based treatment involving the effortful swallow maneuver improve swallowing function in PwPD? Study plan: The investigators will study the effects of a four-week intensive swallowing rehabilitation program in PwPD, over a 2-year period.

NCT ID: NCT05173701 Enrolling by invitation - Parkinson's Disease Clinical Trials

Effects of Probiotics on Peripheral Immunity in Parkinson's Disease

Start date: November 22, 2021
Phase: N/A
Study type: Interventional

Parkinson's Disease (PD) is a common neurodegenerative disease, with no disease-modifying treatment available, therapy is therefore only symptomatic. The pathophysiology of the disease is still unclear, but inflammatory mechanisms are reported to play a prominent role. An involvement of peripheral adaptive immunity, with an imbalance in T cell subpopulations and in the expression of transcriptional factors (TF) in Cluster of Differentiation (CD) 4 positive T cells has been reported. An initial aggregation of α-synuclein (α-syn) in the gut with subsequent propagation along the vagus nerve to the brain has also been hypothesised. Interestingly, in an α-syn overexpressing murine model, the absence of gut microbiota prevented both microglia activation and motor impairment, pointing to a fundamental role of the microbiota in the development of PD. It has been shown that in Peripheral Blood Mononuclear Cells (PBMC) of PD patients, probiotics modulate the in vitro production of cytokines toward an anti-inflammatory profile. The investigators developed a clinical trial protocol for the evaluation of probiotics' effects on the peripheral immune system profile in Parkinson's Disease patients. ROS, Lymphocyte subpopulations, TF levels in PBMC will be assessed at baseline and after treatment with a mixture of probiotics in PD patients to assess immunomodulatory effects of said treatment. Motor and non-motor symptoms of PD will also be monitored through the trial period.

NCT ID: NCT05142085 Enrolling by invitation - Parkinson Disease Clinical Trials

Efficacy of Nano-PSO in Parkinson's Disease.

Start date: September 20, 2021
Phase: N/A
Study type: Interventional

The present research aims to carry out a double-blind, placebo-controlled clinical trial to study the efficacy of a new antioxidant. The primary outcome variables will be the changes observed in PD-motor and non-motor symptoms scales, as well as quality of life during a 6-months period. Global impression on the treatment will be rated after this period. Likewise, presynaptic changes will be studied in positron emission tomography studies, using 2 radiotracers and a dynamic image processing in patients with Parkinson's disease. 125 patients who have a definite diagnosis of PD will be included; 25 of them will be subjected to a triple-blind, clinical and molecular study. In addition, 25 other subjects from the same Institution and from 4 other collaborating centers will be part of the clinical arm of this study during the period September 2021- September 2022. During the first visit, various clinical data of the participants will be recorded such as: age, gender, family history, current medical conditions, and drugs dosage in addition to a comprehensive neurological examination. Subsequently, the signing of the informed consent will be obtained, and general laboratory tests and a brain RMI in 3dT1 and SWI sequences will be performed. A series of disease-specific scales will be applied in order to assess motor functional capacity, cognition, sleep, and other non-motor symptoms before drug delivery. Randomization will be made in blocks of 5 treatments: 3 nano-PSO and 2 placebos. Treatments will be delivered in form of bottles containing 100 capsules each after baseline and intermediate visit. 25 patients will also give their consent to perform 2 PET studies (positron emission tomography) to assess presynaptic dopaminergic function. This implies conducting these studies on 2 occasions (at the beginning and at the end of treatment), with emphasis on striatal activity to study the effect of treatment with Nano-PSO.

NCT ID: NCT05008094 Enrolling by invitation - Parkinson Disease Clinical Trials

The Epidemiology of Parkinson's Disease in Croatia and the Influence of Genetic Factors and Microbiota on the Progression and Treatment Outcomes of the Disease (GiOPARK)

GiOPARK
Start date: May 1, 2020
Phase:
Study type: Observational

Parkinson's disease (PD) is the second most common neurodegenerative disease, which affects 2-3% of the general population above 65 years. There are significant differences in incidence depending on geographical location, race, and ethnicity. The exact cause of the disease is still unknown, but the role of genetic and environmental factors has already been established. Certain genetic forms of the disease make up for a small percentage, so it is thought that environmental factors have a more significant impact on the development of the disease. The incidence of PD is higher in people exposed to significant quantities of pesticides and traumatic brain injury, while there is a smaller incidence in smokers and people consuming more significant quantities of caffeine. The project will finish in four years, with the first 20 months dedicated to the first phase (genetic-epidemiological research), and the entirety of the 48 months for the second phase of the project (prospective clinical research). The main goal of the first phase of the project is to determine which genetic mutations are the ones most represented in the Croatian population afflicted with the familial form of PD. In the second phase the main goal is to determine the influence of genetic factors and microbiological factors on the disease's progression as well as on the treatment outcomes. Specific goals of this part of the project are to determine how many patients in the general population of PD patients present with a genetic disorder and which genes have a role in that disorder, as well as determine the composition of intestinal and oral microbiota both in the patient test group and the healthy control group. Furthermore, specific goals are to evaluate the effects of standard PD treatment on the composition of microbiota, neurodegeneration progression and the activity of neuroinflammation in the central nervous system (CNS) and to examine whether there is a link between the physiological and the pathophysiological function of microbiota, using markers of disease progression and glial activity. Last specific goal is to analyze potential pathological conformation protein forms that could be used as a biomarker in early stages of the disease and a biomarker of disease progression. The first phase of the study will provide the first epidemiologic data on the familial form of PD, as well as the mutations most represented in patients with PD in Croatia. Additionally, the prospective clinical study will contribute to enlightening the intertwined effects of genetic and environmental factors in the emergence and progression of the disease, as well as their effect on treatment outcome. Intestinal and oral microbiota composition analysis will determine whether there is a difference between PD and the healthy population while using the short-chain fatty acid profile will determine the metabolic differences between the two groups. Analyzing the markers of CNS homeostasis, inflammation, and neuroglial function will determine the progression of the disease and also correlate them to genetic factors as well as the microbiota function and composition. Analyzing the pathological conformation forms of alpha-synuclein could lead to the discovery of novel biomarkers in the early stages of the disease, as well as to follow the progression of the disease

NCT ID: NCT04963894 Enrolling by invitation - Parkinson Disease Clinical Trials

Effects of Home Rehabilitation of Balance Based on Functional Exercises in People With Parkinson's Disease

balanceHOME
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Balance rehabilitation programs in people with Parkinson's disease (PD) that include functional exercises, i.e. using tasks of daily living in training, show improvements in variables related to balance and gait. In previous studies, the advantage of taking into account the specificity of the task and the inclusion of specific objectives for the motor rehabilitation of people with PD has been observed. The interventions with the best results are usually carried out in hospital centers or rehabilitation gyms and, in groups of people. Due to the situation experienced since last March 2020, due to the Covid-19 pandemic, group rehabilitation programs have been affected, especially in those pathologies that involve older age groups such as PD. For this reason, the need to transfer therapies to the home is considered, as well as to make people aware of the importance of continued rehabilitation, even from other settings. In the present study, we propose a rehabilitation program at home for people with Parkinson's disease based on balance with functional exercises, which will be compared with a home control group of people with PD that stay at home without any physical rehabilitation, and a conventional group physiotherapy program carried out in a rehabilitation gym in groups of 6 people. The effects of the experimental intervention and the control groups will be evaluated on outcomes related to balance using a dynamometric platform and outcomes related to gait through 3D photogrammetry.

NCT ID: NCT04928079 Enrolling by invitation - Parkinson Disease Clinical Trials

6-year Follow-up of Dysphagia in Patients With Parkinson's Disease

Start date: January 1, 2014
Phase:
Study type: Observational

We recruited 116 patients with idiopathic PD who were from the Neurology clinic of the Second Affiliated Hospital of Zhejiang University, School of Medicine from January 2014 to November 2014. Perform videofluroscopic swallowing study and psychiatric and neurological evaluations and followed up after 6 years.