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NCT07521384
This prospective observational study collects real world data on participants receiving regenerative therapies administered internationally and delivered intranasally via the Kurve Therapeutics ViaNase device. The study does not assign treatment. Participants are enrolled after receiving, or electing to receive, therapy as part of routine clinical care outside the study. Participants are observed in one of three cohorts based on the therapy received: MuSE cell derived exosomes, MuSE stem cells, or combination therapy. The objective is to evaluate safety, tolerability, and changes in inflammatory biomarkers and clinical outcomes over time in a real world setting. The study also evaluates changes in inflammatory biomarkers, including serum tumor necrosis factor alpha (TNF-α), to better understand the biological effects of these therapies.
NCT07495462
Parkinson's Disease (PD) is a progressive brain disorder that affects movement and balance. It can cause slowed movements, stiffness, tremor, balance problems, and an increased risk of falling. Many individuals with PD develop fear of movement, also referred to as kinesiophobia, and fear of falling. This condition may lead to avoidance of physical activity, which can further worsen balance and movement abilities. This study aims to determine whether adding Motor Imagery (MI) to a standard rehabilitation program can improve balance and reduce fear of movement in individuals with PD. MI is a mental practice technique in which an individual rehearses movements cognitively without actual physical execution. For example, a person may imagine standing up, walking, or climbing stairs. Although the movement is not physically performed, the brain regions involved in movement are activated. MI is safe, does not require special equipment, and may help improve motor control. Eligible participants will be randomly assigned to one of two groups. One group will receive standard physical therapy and rehabilitation exercises, while the other group will receive the same therapy combined with additional MI training. The rehabilitation program will last six weeks. The study will primarily evaluate whether this combined approach improves balance and reduces fear of movement. In addition, the potential effects of the intervention on fall risk, functional mobility and performance, fear of falling, activities of daily living, and motor function will also be examined. Assessments will be performed at the beginning of the study, at the end of treatment, and again at 12 weeks. Researchers hope to determine whether combining MI with conventional rehabilitation provides greater benefits than conventional rehabilitation alone and may help improve rehabilitation strategies for people living with PD.
NCT07013214
The goal of this clinical trial is to learn if a rehabilitative pathway based on dual-task exercise improves balance in patients with Parkinson's disease, compared to a traditional rehabilitation program. It will also investigate the reduction of fall risk, and improvement in autonomy and quality of life. The main questions it aims to answer are: * Does dual-task exercise improve balance more effectively than traditional rehabilitation in Parkinson's patients? * Does dual-task exercise reduce the risk of falls? * Does dual-task exercise improve patient autonomy in daily activities? * Does dual-task exercise enhance the overall quality of life for Parkinson's patients? Researchers will compare a dual-task exercise program to a standard rehabilitation program. Both groups will receive 20 sessions, 2-3 times a week for two months, each lasting 45 minutes. The study will be double-blinded, meaning neither participants nor researchers involved in treatment administration and data collection will know group assignments. Randomization will be done using dedicated software to ensure unbiased group distribution. Participants will: * Have a confirmed diagnosis of Parkinson's disease (Movement Disorder Society criteria). * Be in an early to moderate stage of the disease (Hoehn and Yahr score \< 3). * Be over 30 years old. * Be able to provide informed consent. * Have a stable medication regimen for at least three months. Exclusions include: * Hoehn and Yahr score ≥3. * Severe cognitive or psychiatric disorders (e.g., dementia). * Use of interfering medications or treatments. * Participation in other clinical trials. * Pregnancy or breastfeeding. * Need for medication changes during rehabilitation. Evaluations will be conducted at baseline (T=0), after rehabilitation (T=1), and at a two-month follow-up (T=2). Assessments will include the Tinetti Balance and Gait scales, Timed Up and Go (TUG) test, VAS pain scale, TAMPA Scale for Kinesiophobia, Global Perceived Effect (GPE), Barthel Index, EuroQoL-5D-5L, and ABC Scale. UPDRS, Hoehn and Yahr scale, and MOCA Scale will be administered only at baseline (T=0).
NCT07414290
A Phase I/II Clinical Study to Evaluate the Tolerability, Safety, and Efficacy of VGN-R08b Intra-cerebroventricular injection in Parkinson's Disease Patients with GBA1 Mutations
NCT07381907
Parkinson's disease can cause slow or unsteady walking and balance problems that raise the risk of falls. This study will test whether adding a gentle, non-invasive brain stimulation called transcranial direct current stimulation (tDCS) during a supervised Nordic Walking program improves mobility in people with Parkinson's disease. Participants will be randomly assigned to receive either active tDCS or an inactive (sham) procedure that feels the same but does not deliver current, while both groups complete the same supervised walking program. Sessions occur three times per week for four weeks. We will measure walking speed with a 10-Meter Walk Test as the main outcome, and also evaluate balance, motor symptoms, quality of life, and any side effects. We expect that tDCS given during the walking sessions will help people walk faster and feel steadier compared with the walking program alone.
NCT07308795
Parkinson's disease is a neurodegenerative disorder characterized by both motor and non-motor symptoms. The involvement of respiratory muscles can lead to impairments in respiratory function in these patients. In this study is to evaluate the thickness of abdominal accessory respiratory muscles using ultrasonography in patients with Parkinson's disease. Additionally, the relationship between disease severity and expiratory respiratory muscle strength will be examined. The study will include Parkinson's patients at different stages of the disease, with respiratory muscle thickness measured via ultrasonography. The collected data will then be compared with disease severity and expiratory muscle strength.
NCT07297368
This pilot study evaluates whether a structured, Parkinson's disease-specific Tai Chi programme ("Enhanced Tai Chi") can improve motor and non-motor symptoms in people with Parkinson's disease (PD). PD is a progressive neurological condition associated with motor impairments such as bradykinesia, rigidity, gait disturbance and postural instability, as well as non-motor symptoms including fatigue, pain, mood disturbance, sleep problems and cognitive changes. Although pharmacological treatments improve many motor symptoms, balance and postural control often respond poorly, contributing to falls and reduced independence. Enhanced Tai Chi is a tailored programme developed specifically for people with PD, incorporating elements of Tai Chi and Qi Gong focused on balance control, coordination, postural alignment, body awareness and confidence in movement. This single-site, randomised, controlled pilot trial will enrol 30 adults with idiopathic PD (Hoehn \& Yahr stages I-III), randomised in a 2:1 ratio to Enhanced Tai Chi plus usual clinical care or usual clinical care alone. Participants in the intervention group will complete 36 supervised one-hour sessions over 12 weeks (three sessions per week: one in-person and two delivered remotely), with optional independent practice encouraged. Adherence will be monitored through attendance records. Outcomes will be assessed at baseline, post-intervention and 3-month follow-up. Findings will inform feasibility, acceptability and preliminary efficacy estimates to support the design of a future definitive randomised controlled trial.
NCT07310238
This study aimed to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex on cognitive function and dual-task performance in individuals with Parkinson's disease. Participants completed ten rTMS sessions over two weeks or received sham stimulation. Cognitive status was assessed using the Montreal Cognitive Assessment, and mobility was evaluated through single-task and multiple dual-task Timed Up and Go tests. The study examined whether rTMS could enhance cognitive abilities and improve motor-cognitive performance, which are commonly impaired in Parkinson's disease and contribute to reduced functional independence. Findings indicated that rTMS led to improvements in cognition, single-task mobility, and complex dual-task performance. The intervention was well tolerated, and no adverse events related to the stimulation intensity were reported.
NCT07299240
This single-center, randomized, single-blind, sham-controlled clinical trial aims to evaluate whether remote ischemic conditioning (RIC) can improve sleep disturbances and other non-motor symptoms in patients with Parkinson's disease (PD). Forty-eight PD patients with insomnia will be randomly assigned in a 1:1 ratio to receive either active RIC (cuff inflation to high pressure) or sham RIC (cuff inflation to low pressure) for 7 consecutive days, in addition to their standard antiparkinsonian medications. Subjective sleep scales, sleep diaries, validated rating scales for motor and non-motor symptoms, and overnight polysomnography will be used to assess treatment effects at baseline, after the 7-day intervention, and during short-term follow-up. The study will also explore potential mechanisms of RIC by combining EEG, functional MRI, retinal optical coherence tomography, and blood biomarkers.
NCT07302386
The aim of this study is to examine the benefits that individuals with Parkinson's disease will gain from the rehabilitation program by enabling them to manage their exercise times independently using telerehabilitation method. The main research questions examined in this study are as follows: * Are the improvements in quality of life, walking speed and changes in functionality parameters achieved by individuals with Parkinson's disease through managing their own exercise plans as effective as those achieved through a supervised exercise programme? * Is it effective for Parkinson's patients to manage their own exercise plans in improving their adherence to exercise?
NCT07284823
This research will investigate the safety and usability of the Cionic Neural Sleeve Multistim System for Parkinson's Disease.
NCT07038590
This document is intended to provide participant with information about a research study in which the participant is invited to participate. This study was approved by the Research Ethics Committee of \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_. If the participant decide to participate, will receive personalized information from the investigator. Please read this document beforehand, and the investigator will ask you any questions you may have to understand the details. If the participant wish, the participant can take this document, review it with others, and take your time to decide whether or not to participate. Participation in this study is completely voluntary and free of charge. The participant can decide not to participate, participate, or change your mind by withdrawing your consent at any time during the project without giving any explanation. The investigators assure the participant that this decision will not affect any future participation with this research group. What is the purpose of the study? To analyze whether the use of a physical exercise program in immersive virtual environments (video games) has greater positive effects on Parkinson's symptoms than traditional rehabilitation programs. Why is the participant being offered to participate? The participant is invited to participate because the participant is a person diagnosed with Parkinson's and because, within the Open Science policies of the University of Vigo, the Galicia Sur Biomedical Foundation, and the Nóvoa Santos Foundation, where bringing research closer to the reality of patients is emphasized, the investigators have selected the specialized Parkinson's center of which the participant is a member to participate in this study. What does the participation consist of? The participation consists of carrying out 2/3 sessions per week on alternate days of physical exercise, and depending on whether the participant belong to the control or experimental group, the participant will do it regularly or recreated with a video game. The duration of each session will be 15 minutes. Be part of one group or another will depend on chance (like throwing a coin in the air and it comes up Heads or Cross). The total duration of the intervention in both cases is 3 months. During the project, 2 evaluations will be carried out: Initial evaluation and final evaluation. In all of them they will be collected information in relation to their pharmacological treatment linked to the pathology, autonomy functional balance, gait and risk of falls, functional balance, symptoms and disease monitoring and quality of life. Furthermore, in the experimental group the usability and security of the tool will be evaluated immersive virtual reality used. All these assessments will be carried out in your proximity center on the agreed day and time to optimize said process and will have an approximate duration of 30 minutes. What discomforts or inconveniences does the participation have? The participation requires travel to your reference center to carry out the study. This program, like any physical activity or exercise, may involve greater tiredness and/or musculo-articular discomfort due to the type of exercise to which you will be subjected. No relevant adverse effects have been recorded in the use of immersive virtual environments (video games).
NCT07221266
Parkinson's disease (PD) is a progressive neurological condition that can affect movement, balance, endurance, and overall quality of life. Exercise is widely recognized as one of the most effective non-pharmacological treatments to help people with PD maintain function and independence. However, not all exercise programs produce the same results, and more research is needed to understand which types of exercise offer the greatest physical and physiological benefits. This study is designed to examine how different types of structured exercise programs influence motor function, cardiorespiratory fitness, and markers of overall health in individuals with Parkinson's disease. The goal is to better understand how exercise can be used to improve movement, daily activities, and general well-being, as well as how it affects the body at a physiological level. Participants will be adults diagnosed with idiopathic Parkinson's disease who are medically stable and able to safely participate in exercise. Before beginning the study, participants will complete screening procedures to ensure safety and eligibility. Eligible participants will then be assigned to one of several supervised exercise interventions conducted over a defined period. Each exercise program is designed to improve movement and function but differs in structure or training emphasis (for example, aerobic, functional, or task-specific activity). Exercise sessions will take place under the supervision of licensed physical therapist. Each session will include warm-up, exercise, and cool-down components. Intensity will be monitored using heart rate and perceived exertion to ensure safety and appropriate challenge. Participants will attend sessions multiple times per week for 8 weeks. Researchers will collect information about movement abilities, balance, walking, endurance, and daily function using standardized physical therapy assessments such as gait tests, balance measures, and questionnaires related to quality of life at baseline, after 8-weeks of intervention and once more after a 4-week follow-up. In addition, blood samples will be collected to analyze physiological responses to exercise at the same 3 testing intervals. These samples will allow investigators to measure biomarkers related to cardiovascular health, nitric oxide availability, oxidative stress, and inflammation. These biological indicators can help identify how exercise affects underlying health mechanisms that may contribute to improved function in people with Parkinson's disease. All data will be collected by trained research personnel who are experienced in working with individuals with Parkinson's disease. Participants will be monitored for safety at each session, and any adverse events will be documented and reviewed by the principal investigator and the Institutional Review Board (IRB). By comparing changes across the different exercise programs, this study aims to determine which interventions have the most meaningful impact on mobility, endurance, and quality of life, as well as which ones produce measurable physiological benefits. Results from this research may help guide physical therapists, rehabilitation professionals, and people with Parkinson's disease in choosing the most effective exercise approaches for maintaining function and promoting overall health. Ultimately, this project seeks to contribute to the growing evidence that targeted, engaging, and appropriately dosed exercise can play a key role in improving the lives of people living with Parkinson's disease. The findings may also help inform future clinical practice guidelines, community exercise programs, and long-term wellness strategies for individuals with movement disorders.
NCT07167979
Age is one of the primary risk factors for falls, with risk increasing as people get older. Research on fall risk and prevention has identified hundreds of contributing factors, showing that falls have complex and multifactorial causes. Risk factors can be categorized as environmental, extrinsic, or intrinsic. Intrinsic factors include physiological aspects-such as reduced lower-limb strength, impaired gait and balance, weaker grip strength, diminished sensory function, and poorer sensorimotor control-as well as psychological aspects, including fear of falling, depression, and cognitive decline. Strongly associated intrinsic risk factors include a history of falls, physical weakness, gait and balance disorders, certain medications, and dizziness. While fixed factors like age and fall history cannot be changed, identifying and targeting modifiable risk factors is crucial for prevention. Among these, gait and balance impairments are considered the most important modifiable intrinsic factors.
NCT07157345
Parkinson's disease (PD) poses a severe threat to human health, and its incidence is rising year by year. Current therapeutic options are limited by significant shortcomings. Pathological aggregation of α-synuclein and the consequent death of dopaminergic neurons are the primary drivers of PD pathogenesis. While siRNA-mediated knockdown of α-synuclein can offer some protection to dopaminergic neurons, its clinical utility is hampered by low cellular uptake, off-target effects, and transient activity. These drawbacks underscore the urgent need for novel strategies that can efficiently and specifically degrade α-synuclein to delay or even halt PD progression. Our prior work identified tat-βsyn-deg (PDR-001), a three-segment peptide that selectively targets α-synuclein. When packaged into AAV9 capsids and delivered via bilateral stereotaxic injection into the subthalamic nucleus, this peptide effectively reduces α-synuclein within the target region. Pre-clinical studies in both human-α-synuclein-expressing mice and non-human primate models of PD have demonstrated robust α-synuclein clearance and marked improvements in motor deficits (see Research Foundation). The present project will advance PDR-001 into first-in-human studies to evaluate safety and explore preliminary efficacy. Unlike conventional symptomatic therapies, this approach targets the root cause of PD, setting the stage for disease-modifying treatment. Successful translation would establish a new therapeutic paradigm capable of slowing or preventing PD progression.
NCT07148700
Introduction: Falls are common in Parkinson's disease (PD), affecting 30-90% of patients annually, with more than half experiencing recurrent falls. Identifying balance assessment tools that are both practical and predictive of fall risk is therefore essential. This study aimed to investigate the relationship between fall frequency and three balance assessment tools: the Biodex Balance System (objective), the Falls Efficacy Scale-International (FES-I) (self-reported), and the Mini-Balance Evaluation Systems Test (Mini-BESTest) (functional). Methods: Patients with PD at Hoehn and Yahr stages 1-3 will be included in the study. Fall data will be collected using a fall diary, while objective balance will be assessed with the Biodex Balance System, functional performance will be evaluated with the Mini-BESTest, and self-reported balance confidence will be measured with the FES-I.
NCT06602544
Freezing-of-gait (FoG) in Parkinson Disease (PD) is one of the most vivid and disturbing gait phenomena in neurology. Often described by patients as a feeling of "feet getting glued to the floor," FoG is formally defined as a "brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk." This debilitating gait phenomena is very common in PD, occurring in up to 80% of individuals with severe PD. When FoG arrests walking, serious consequences can occur such as loss of balance, falls, injurious events, consequent fear of falling, and increased hospitalization. Wearable robots are capable of augmenting spatiotemporal gait mechanics and are emerging as viable solutions for locomotor assistance in various neurological populations. For the proposed study, our goal is to understand how low force mechanical assistance from soft robotic apparel can best mitigate gait decline preceding a freezing episode and subsequent onset of FoG by improving spatial (e.g. stride length) and temporal features (e.g. stride time variability) of walking. We hypothesize that the ongoing gait-preserving effects can essentially minimize the accumulation of motor errors that lead to FoG. Importantly, the autonomous assistance provided by the wearable robot circumvents the need for cognitive or attentional resources, thereby minimizing risks for overloading the cognitive systems -- a known trigger for FoG, thus enhancing the repeatability and robustness of FoG-preventing effects.
NCT06921122
Parkinson's Disease affects the brain and causes several movement problems. These problems include stiff muscles, slow movements, shaking when resting, and trouble keeping balance. As the disease gets worse, it can also affect how people speak. Doctors and therapists have found better ways to test how Parkinson's affects speech. There's one special therapy method that's considered the best for helping people with Parkinson's speak better. Now, they're also using a new tool called IOPI (Iowa Oral Performance Instrument) to help test and treat speech problems. This research project wants to see if using IOPI can help people with Parkinson's speak better. Here's how they'll do it: First, they'll split people with Parkinson's into two groups randomly. Everyone will take speech tests, like: Holding an "a" sound as long as they can; Saying "pataka" repeatedly; Counting from 1 to 15; Reading sentences; Speaking freely about a topic; They'll also measure how strong their tongue is using IOPI. Then, one group will get therapy using the IOPI tool, while the other group won't. After the therapy is done, they'll test everyone again to see if the IOPI therapy helped improve their speech. The researchers hope this study will show that IOPI is a helpful new tool for speech therapy, giving therapists more ways to help people with Parkinson's speak better.
NCT06858254
The purpose of this study is to measure outcomes using intranasal and intravenous autologous bone marrow mesenchymal stem cells (BM-MSCs) for Parkinson Disease (PD) and Parkinson's Plus (PPS) patients.
NCT06745011
Description of a method to detect Parkinson's disease or Parkinson's-like disease at an early stage (Prodromal Parkinson's Disease) where damage is still confined to the peripheral nervous system damage. Simultaneous collection of biological material to establish a biobank for use as prognostic biomarkers for the development of Parkinson's disease and other neurodegenerative diseases in which pathological alpha-synuclein deposits accumulate.