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NCT07604883
This prospective observational study aims to identify and preliminarily validate molecular biomarkers, including microRNAs and metabolites, for the early differentiation of Parkinson's disease (PD) from atypical parkinsonian syndromes (APS). The study will enroll up to 100 patients with PD, 50 patients with suspected APS, and 50 healthy controls. Participants will undergo clinical assessments and provide blood, urine, and stool samples at baseline and after 12-18 months of follow-up. Molecular analyses, including microRNA profiling, metabolomics, RNA sequencing (RNA-seq), and microbiome analysis, will be performed to identify disease-specific diagnostic signatures. The primary objective is to detect differences in molecular profiles among patients with PD, patients with APS, and healthy controls. Secondary objectives include evaluating the diagnostic accuracy of biomarker panels and assessing longitudinal changes in these biomarkers over time. Although participants will not receive direct therapeutic benefits, the study may contribute to the development of non-invasive tools for the early diagnosis and improved differentiation of parkinsonian disorders.
NCT07554833
Parkinson's disease (PD) is a brain disorder that causes progressive problems with movement, such as slowness, stiffness, tremor, and difficulty walking. Many people with PD also develop problems with thinking and memory. Current medications can help control movement symptoms but often become less effective over time and may cause side effects. There is a need for additional treatment options that can address both movement and thinking difficulties in PD. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic pulses delivered to the scalp to stimulate specific areas of the brain. Previous research has shown that rTMS targeting the motor cortex (the part of the brain that controls movement) can improve motor symptoms in people with PD. The purpose of this pilot study is to evaluate whether an accelerated course of rTMS targeting the motor cortex can improve movement and thinking abilities in people with mild to moderate Parkinson's disease. The study will enroll 40 participants aged 50 to 90 years at the San Francisco Neurology and Sleep Center. Participants will receive 6 sessions of rTMS using the EXOMIND™ device, administered twice per week over approximately 3 weeks. Each session delivers high-frequency magnetic stimulation to the motor cortex on both sides of the brain. Participants will be assessed before treatment, at the last treatment session, and at 1-month and 3-month follow-up visits. The primary outcome measure is the change in motor symptoms as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) at 1 month after treatment. Secondary outcomes include additional measures of walking and gait, domain-specific cognitive testing using the Creyos cognitive battery (assessing memory, attention, reasoning, and other thinking skills), the Montreal Cognitive Assessment (MoCA), depression symptoms (PHQ-9), and quality of life (PDQ-39). This is a single-center, open-label study with no placebo or control group. Total participation duration is up to 139 days, including screening, treatment, and follow-up visits.
NCT07400731
This is a prospective, multicenter, randomized, two-period study designed to evaluate the safety and effectiveness of the EarStim System for intermittent relief of motor symptoms in patients with Parkinson's disease experiencing wearing-off phenomena. Adult patients with moderate to severe Parkinson's disease (MDS-UPDRS Part III score ≥33) receiving oral dopaminergic therapy will be enrolled. Period A is a randomized, double-blind, sham-controlled phase conducted in a clinical setting. Period B is an unblinded, standard-of-care-controlled phase evaluating the effectiveness of the EarStim System during home use over 90 days.
NCT07478146
This randomized controlled trial will investigate the effects of a 12-week supervised aerobic training program on cerebrovascular function, peripheral vascular health, cardiovascular autonomic modulation, cognition, non-motor symptoms, sleep, mood, gait biomechanics, quality of life, and body composition in patients with Parkinson's disease (Hoehn \& Yahr stages 1-3). Participants will be randomly allocated to aerobic training or usual care.
NCT07356414
The goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease. The aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study. Patients who are given the exercise training will be compared to participants who are treated using the usual standard treatment. Patients will have 6 weeks of twice-weekly SwallowFIT training. Each session will be an hour long.
NCT07485218
With our study, the investigators aim to assess the impact of the fatigue experienced during daily life activities (tiredness) and whether there is a relationship with muscle fatigue during an exercise task. The results of this study may be used to improve the assessment of fatigue in older adults and enhance clinical management. 1. General information An increase in fatigue is considered one of the main causes of reduced quality of life in older adults and in people suffering from chronic diseases. However, the investigators still know little about the mechanisms underlying fatigue in older adults, mainly because most of the available tools were developed to assess this symptom in younger populations with specific diseases, without proper adjustments for physical activity or age. In 2015, the Pittsburgh Fatigability Scale (PFS) was developed as a self-administered questionnaire to assess both physical and mental fatigue in older adults. The PFS consists of 10 questions describing activities of varying duration and intensity. The other scale the investigators will ask participants to complete is called the Fatigue Severity Scale (FSS): a 9-item questionnaire that evaluates fatigue intensity in various situations over the past week. Participants' fatigue will also be assessed during two motor tasks simulating daily activities: a handgrip test and a seated leg exercise mimicking walking. If participants decide to take part in our research project, participants will complete the PFS and FSS questionnaires once (5-10 minutes) and perform two brief motor exercises to determine the onset and progression of muscle fatigue. The exercises will last about 20 minutes, with an additional 10 minutes for preparation. Each contraction will last a maximum of 2 minutes. The project will last 12 months (Swiss section) and will be conducted at \[(1) the nursing homes of the Multistruttura di Bellinzona, the Fondazione Parco San Rocco facilities in Morbio Inferiore and Coldrerio, and the Opera Charitas nursing home in Sonvico\] (period: December 2024 - May 2025); and (2) at the \[San Raffaele University Research Institute\] in Milan, Italy, where 40 older adults with Parkinson's disease will participate (September 2026 - March 2027). This research project is conducted in accordance with Swiss legislation and current international ethical guidelines. It has been reviewed and approved by the Ethics Committee of the Canton of Ticino. 2. Study procedure The testing session will last a maximum of 30 minutes and will include the following steps: Discussion of the study procedures. Verification of appropriate leg clothing. The exercise can be performed either by wearing shorts or by rolling up long trousers to expose the upper half of the thigh. Review of the completed Pittsburgh Fatigability Scale (PFS) questionnaire and completion of the Fatigue Severity Scale (FSS), both available in Italian. Performance of two motor exercises (a surrogate walking test and a handgrip test). 1. First, participants will be instructed on how to perform the surrogate walking test, which evaluates leg muscle fatigue. During the exercise, participants will push with their legs and foot on a movable platform that slides along rails within the device. The sliding motion is resisted by elastic bands that stretch and shorten as participants push. The exercise will be repeated for several cycles until participants are told to stop. To measure muscle fatigue, surface electrodes (non-invasive) will be placed on the skin over two thigh muscles. 2. After a 5-minute rest, participants will be asked to perform the handgrip test with participants' right hand (see Figure 3). The maximal handgrip test will be performed while seated, with participants' forearm resting on a table. The test will be repeated several times until participants are instructed to stop.
NCT07467460
In recent decades, advances in medicine have significantly improved both quality of life and life expectancy. However, these positive effects are also associated with a considerable increase in the prevalence of age-related diseases. Among these, Alzheimer's disease (AD), Parkinson's disease (PD), and type 2 diabetes (T2D) currently represent a major threat to human health. PD and AD are the most common neurodegenerative diseases in industrialized populations. In particular, AD accounts for 54% of all cases of dementia, with a prevalence of 4.4% among individuals over 65 years of age. PD has a prevalence of about 1% in people older than 60 years, reaching up to 4% in those over 80 years of age. AD and PD are highly disabling disorders with a slow but progressive course, caused by the degeneration and/or death of nerve cells. This results in impairments in the control of movement and balance, as in the case of PD, or in cognitive functioning, as in AD. To date, neither effective treatments nor early diagnostic tools are available to address these conditions in the initial phase of neurodegeneration. Likewise, there are no tools capable of monitoring disease progression and improving patients' adaptation to therapy. Moreover, although the association between T2D and the risk of PD and/or AD has long been recognized, these conditions were historically considered unrelated. Recent evidence from clinical and epidemiological studies suggests the existence of shared pathophysiological mechanisms associated with insulin resistance and persistent inflammation in several metabolically relevant tissues, such as adipose tissue and the brain. However, the mechanisms that increase the risk of PD and/or AD in individuals with T2D remain poorly understood. These data highlight how relevant these diseases are for the National Health System and demonstrate that they represent one of the most important priorities to be addressed, requiring substantial investments in both scientific research and early diagnostic strategies. Therefore, the present project proposal, which aims to develop new minimally invasive tools for the early prediction and monitoring of neurodegenerative diseases such as AD and PD, will help fill an important gap in the clinical and therapeutic management of these patients.
NCT07440563
Parkinson's disease (PD) is a progressive, neurodegenerative movement disorder characterized by a combination of motor and non-motor symptoms. Auricular vagus nerve stimulation (aVNS), one of the physiotherapy methods used in PD, has been shown in studies to have a positive effect on symptoms such as motor symptoms, gait disturbance, freezing, and cognitive impairment, and is considered a safe and feasible method. The aim of this study is to investigate the effects of neurological physiotherapy and rehabilitation, in combination with aVNS application, on balance, gait, and clinical symptoms in individuals with PD.
NCT07422675
This is a randomized, placebo-controlled, single ascending dose (SAD) study of SER-252 in participants with Parkinson's Disease (PD) and motor fluctuations.
NCT07427498
The goal of this observational study is to better understand the mechanisms of hallucinations in patients with Parkinson's disease. The main question it aims to answer is: Do prior expectations increase the rate of false perceptions during a visual stimulus detection task more in Parkinson's disease patients with visual hallucinations compared to those without? Participants will undertake a computer task involving face detection and a battery of neuropsychological tests.
NCT07439926
The goal of this observational study is to investigate the causes of hospitalisation via emergency services in patients with degenerative parkinsonian syndromes. All causes of hospital admission through the emergency department among patients with Parkinson's-related disorders were analysed in order to understand their vulnerability and the factors that worsen their health status. Data from included patients were compared to those of age-matched individuals without Parkinson's disease.
NCT07217054
The goal of this observational study is to learn whether tissue samples taken from the colon during routine colonoscopy can detect signs of Parkinson's disease or REM Sleep Behavior Disorder (RBD). The main question it aims to answer is: Can doctors find a protein called alpha-synuclein in colon tissue samples from people with Parkinson's disease and RBD? Currently, Parkinson's disease is diagnosed by observing symptoms like tremors and movement problems and RBD by loss of muscle atonia during REM sleep, but by then the disease has already progressed significantly. Earlier detection could help doctors start treatment sooner.
NCT07399522
Parkinson's disease is a progressive neurodegenerative disorder with no curative treatment currently available. Its symptoms lead to increasing limitations in daily activities, with impairments in manual dexterity being particularly relevant. Handwriting difficulties are common in patients with Parkinson's disease; however, it remains unclear whether a rehabilitation program based on handwriting exercises can improve overall manual dexterity and daily functioning. This randomized, single-blind controlled trial aims to evaluate the effects of a 12-week home-based calligraphic handwriting exercise program on manual dexterity in patients with Parkinson's disease. Participants will be recruited from the Movement Disorders Clinic of Hospital 12 de Octubre (Madrid, Spain) and randomly assigned to either an intervention group or a control group. Manual dexterity will be primarily assessed using the Purdue Pegboard Test across scheduled study visits. Secondary outcomes will include measures of dexterity related to activities of daily living, quality of life, and motor function.
NCT07360977
Glucosinolates (GLs) are phytocompounds mainly found in the Cruciferae (Brassicacea) and Moringa oleifera plants. The hydrolysis of GLs by myrosinase led to the production of isothiocyanate (ITCs). ITCs consumption was associated with different health promoting effects, including to neuroprotective, anti-oxidant and anti-inflammatory capacities. In particular, they showed neuroprotective effects in experimental models of neurodegenerative diseases, including multiple sclerosis (MS) and Parkinson's disease (PD). From different GLs, different ITCs are originated. In particular, from glucoraphanin (GRA) the ITC sulforaphane (SFN) is obtained. The PI of the project is one of the proprietor of a patent (EP2908850B1) for the application of (Rs)-GRA with myrosinase in a buffered solution for the treatment of neurodegenerative diseases. The aim of this project is to evaluate the effects of the administration of bioactivated GRA in different cohorts of adult patients, affected by MS and PD, but also a cohort of pediatric patients affected by neuromuscolar and degenerative diseases. The effects of bioactivated (Rs)-GRA administration will be evaluated with a combination of clinical evaluations and a multiomic (metabolomic, genomic) approach.
NCT07327645
Parkinson's disease (PD) is a neurological disease that includes four main findings: resting tremor, bradykinesia, postural instability, and rigidity, in addition to many motor and non-motor symptoms . PD, the most common form of Parkinsonism, is a chronic and progressive disease characterized by the loss of dopaminergic neurons located in the pars compacta region of the substantia nigra. Its degenerative prognosis, characterized by motor and non-motor problems such as bradykinesia, tremor, rigidity, abnormal postural control, gait disorders, depression, and cognitive impairment, makes the management of the disease difficult . The incidence of PD, which typically begins around the ages of 55-60, varies between 15-250/100,000. Studies conducted in Turkey have indicated an incidence of 202/100,000 . In PH, as the disease progresses, there is a decrease in trunk mobility, forward flexion posture, and consequently loss of postural stability, particularly due to axial rigidity. Trunk stiffness and decreased trunk muscle strength are greater in individuals with PH compared to healthy controls. It has been noted that the decrease in trunk mobility impairs both anterior-posterior and lateral balance, and that individuals with PH experiencing these symptoms have difficulty in timing and scaling effective corrective movements, resulting in an increased risk of falls. Gait disorders are considered one of the most disabling aspects of PH and can strongly affect the patient's independence and quality of life. The underlying mechanisms of gait disorders are multifactorial and usually result from a multisystem lesion involving both dopaminergic and non-dopaminergic mechanisms . In addition to the clinical and functional effects of gait disorders, a more important issue is that this impairment in gait can result in falls and trauma. The fact that gait disorders are affected by the motor and non-motor symptoms of the disease, and that they are parallel to longevity and cognitive decline, increases the importance of treatment . Therefore, rehabilitation interventions aimed at treating or alleviating gait disorders should be one of the main focuses in individuals with PH . Falls are one of the most important causes of morbidity for PH . Approximately 60% of PH patients fall at least once a year, and falls are recurrent in at least one-third of these patients . Falls, which occur as a result of various factors, lead to injuries, fear of falling, decreased independence, decreased quality of life, and increased healthcare costs in patients. Fear of falling leads to a decrease in the patient's self-confidence, withdrawal from social life, and the choice of an inactive lifestyle, resulting in an increased risk of falling. This situation becomes a vicious cycle over time. While 28-55% of elderly people living at home fear falling, this rate increases to 50-65% in those who have fallen before . In PH patients, this rate is much higher than in healthy controls and is important in predicting future falls . Therefore, it is stated that fear of falling should be included in the assessment and treatment programs of individuals with PH . Quality of life is a multidimensional outcome measure consisting of three areas: physical, mental, and social, which are influenced by the individual's personal characteristics and environmental factors . Since chronic and progressive diseases affect every aspect of an individual's life, health-related quality of life is taken into consideration in the management of such diseases . PH affects the individual's ability to independently perform almost all daily living activities and causes negative consequences in quality of life. PH affects the individual not only physically, mentally, and socially, but also economically for the individual and their family due to the additional financial burden brought about by care and treatment costs . Therefore, the assessment of quality of life in individuals with PH is important and necessary . Proprioceptive Neuromuscular Facilitation (PNF) is a method frequently used by physiotherapists to facilitate the emergence of motor responses through the stimulation of proprioceptors and to improve voluntary control in the central nervous system . The International PNF Association defines the PNF philosophy under 5 subheadings: positive approach (mental participation in therapy), functional approach (integrating real tasks from daily life), mobilizing reserves (radiation principle), holistic treatment of the individual, motor learning, and control principles using motor learning. PNF fully complies with the International Classification of Functioning, Disability and Health (ICF) because it addresses the relevant patient with their personal and environmental context components of deficiencies, activity limitations, and participation restrictions .
NCT07351032
The purpose of this study is to understand how a specific brain area, the Posterior Parietal Cortex (PPC), plays a role in movement transfer from walking on a split-belt treadmill (SBT) to walking on the ground in people with Parkinson's disease (PwPD). Here, investigators will apply repeated transcranial magnetic stimulation (rTMS) to upregulate the PPC. Then, the differences in the gait parameters between pre- and post-interventions will be compared between the TMS-active and the TMS-sham.
NCT07190235
This study aims to investigate the effects of high-frequency and low-frequency repetitive transcranial magnetic stimulation (rTMS) over the supplementary motor area (SMA) on gait performance, especially gait initiation, in individuals with Parkinson's disease (PD). Furthermore, the investigators will explore the impact of rTMS over the SMA on walking speed, functional mobility, and limits of stability in PD. It is hypothesized that rTMS over the SMA will improve gait performance in PD.
NCT07306104
The goal of this clinical trial is to learn to what extent daily stimulation of the brain with transcranial pulsed electromagnetic fields (T-PEMF) works to treat persons with Parkinson's Disease. The main questions it aims to answer are: * How does 6 months of daily treatment (30 minutes/day) with T-PEMF affects neuro-mechanical and molecular biological factors compared with placebo treatment in persons with Parkinson's disease? * How does 12 months of daily treatment (30 minutes/day) with T-PEMF affects neuro-mechanical and molecular biological factors in persons with Parkinson's disease an does 12 months of T-PEMF alters the need for medication intake? The neuro-mechanical outcomes are compared with the "natural" progression of the disease as well as with a healthy reference group. Furthermore, it will be examined whether 12 months of T-PEMF treatment alters the need for medication intake. Participants in the intervention group will: * receive one 30 min treatment session daily for 12 months * receive either T-PEMF or sham treatment for the first 6 months * receive active T-PEMF treatment the last 6 months * visit for tests before treatment initiation, after 6 months of treatment and after 12 months of treatment.
NCT07180004
Parkinson's disease (PD) is the second most common neurodegenerative disease, characterized pathologically by the progressive loss of dopaminergic neurons in the substantia nigra and clinically by the presence of motor symptoms such as bradykinesia, resting tremor, and/or rigidity.Patients with Parkinson's disease (pwPD) often exhibit poor manual dexterity and decreased strength. Fine motor deficits seen in PD include an inability to control cognitive power/force, poor manual dexterity, and motor dysfunction, which includes difficulties achieving the angles, speed, and coordination required for basic movements. Anatomical strength, as detailed in activities of daily living (ADL), is an important indicator of motor characteristics and vitality.Studies have shown a strong relationship between postural control and fine motor functions. For high-quality distal movement, better proximal stabilization is necessary. During upper extremity functions, the body's center of gravity must shift with arm movements, allowing adaptation to changing gravity. Good trunk control is essential in this dynamic process of maintaining balance. Studies examining this link between trunk control, balance, and hand functions are available in the literature. Among these studies conducted in diverse populations, studies involving PD are very few. Investigating parameters such as grip strength, upper extremity dexterity, and reaction time in PD will fill the gap in the literature. Meta-analysis studies have shown that muscle strength and strength in individuals with PD are lower than in healthy individuals. Furthermore, muscle strength in PD has been shown to be related to functional capacity and disease severity. In light of all this information, our study was designed to investigate the relationship between upper body muscle strength, particularly proximal and distal, and manual dexterity in PD. In this direction, the aim of this study is to determine the relationship between proximal and distal muscle strength and upper extremity functional abilities in PD.
NCT07193303
Parkinson's disease (PD) is the second most common neurodegenerative disease, characterized pathologically by the progressive loss of dopaminergic neurons in the substantia nigra and clinically by the presence of motor symptoms such as bradykinesia, resting tremor, and/or rigidity. Among the motor deficits frequently observed in PD, patients are known to frequently report difficulties with manual dexterity. Many upper extremity and manual dexterity deficits are present in PD. Motor imagery (MI) is the imaginal execution of motor activities or the activation of specific muscles in the absence of any explicit feedback. This area of rehabilitation has been shown to be effective in improving and developing motor skills in many neurological conditions where patients exhibit motor recognition and execution impairments. MI can be applied at all stages of recovery from PD, is highly effective in movement-related pathologies, and can be performed independently.There is sufficient evidence that MI improves motor performance and learning in individuals with neurological disorders such as multiple sclerosis, stroke, and spinal cord injury. The study was designed to investigate the immediate effects of mental imagery, which is thought to be effective in controlling difficulties in planning and initiating movements in PD, on upper extremity skills. Therefore, the aim of this study was to determine the effect of mental imagery on upper extremity skills in PD.