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Browse 1,410 clinical trials for parkinson's disease. Find studies that match your criteria and connect with research centers.
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NCT07505394
Impulse control disorders and related behaviors (ICDRBs) are characterized by pathological gambling, compulsive shopping or eating, and hypersexuality, but other related behaviors have been described, e.g. hobbyism, and punding. ICDRBs are frequent in Parkinson's Disease (PD), affecting up to 50% of the patients after 5 years with major medical, social, and legal impact, with life changing consequences for patients and caregivers. The main risk factor is dopaminergic therapy, particularly the cumulative dose of dopamine agonists (DA). On the other hand, the dopaminergic therapy is necessary to control motor symptoms, and DA have demonstrated efficacy in delaying motor complications occurring in PD. Ideally, dopaminergic therapy would have to be adjusted to the individual risk of developing ICRDBs to maximize the benefit/risk ratio of each drug. However, despite several clinical risk factors associated with the risk of ICDRBs (in addition to the dopaminergic therapy), it is still not possible to predict their risk at the individual level, and not every patient treated with dopaminergic medications will develop ICDRBs. A machine learning algorithm to predict ICDRBs, based on clinical data, validated by cross-validation on independent replication cohorts has been developed. The PREVENT-ICD study proposes to test the efficacy of a new application, ICD-Shield, based on an algorithm to predict and prevent ICDs,in a multicenter randomized controlled trial to prevent ICDRBs in PD patients by proposing to the clinician treatment adjustment according to the risk predicted by the algorithm, as compared to the standard of care (SoC)
NCT06508801
This study is being done to understand how reducing blood flow (BRT) during balance-challenging strengthening exercises (instability resistance training, or IRT) can help improve symptoms of Parkinson's disease.
NCT04650932
Deep brain stimulation (DBS) in the dorsal region of the subthalamic nucleus (STN) is very effective for reducing motor symptoms of Parkinson's disease (PD). Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, current stimulation parameters often lead to worsening in verbal fluency, executive function, and, particularly, cognitive control. There is evidence suggesting that low frequency oscillatory activity occurs across brain circuits important in integrating information for cognition. Preclinical studies and human recording studies indicate these low frequency theta oscillations drive cognitive control during cognitive tasks. Thus, the purpose of this study is to determine the safety, tolerability, and efficacy of low frequency stimulation (LFS) of the ventral STN alongside standard high frequency stimulation (HFS) of the dorsal STN in patients with PD.
NCT07502066
The goal of this one blind-randomized controlled clinical trial is to evaluate the clinical effectiveness of a telerehabilitation (TR) protocol focusing on balance rehabilitation in patients with neurodegenerative diseases (Parkinson's Disease, Multiple Sclerosis). The secondary objectives of the study are: 1. To evaluate the effects of clinical treatment on Health-Related Quality of Life (HRQOL) outcomes. 2. To collect data on process measures: user needs (patients and caregivers), treatment adherence, usability, satisfaction, technological acceptance. Participants will perform 20 rehabilitation session (physiotherapy) for balance improvement. Experimental group patients will be trheated through tele-rehabilitation performing exercise with an hospital physiotherapist. Researchers will compare telerehabilitation group to usual care group to see if there is a significant improvement in motor function, particularly in balance and mobility tests, as well as an improvement in quality of life.
NCT03454425
The objective of this study is to test the efficacy and safety of unilateral subthalamotomy performed using the ExAblate System for the treatment of Parkinson's disease (PD) motor features.
NCT06319118
Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson\'s disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson\'s disease and cognitive impairment were enrolled, and the treatment was followed up for 12 weeks: dihydroergotine mesylate sustained-release tablets + conventional treatment (treatment group patients, 80 cases), placebo + conventional treatment (control group patients, 40 cases), and the main indicators were observed: the improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was observed, and the secondary indicators were observed: the effect of dihydroergotine mesylate sustained-release tablets on the cognitive function of PD patients was observed. Expected results: The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group. The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients.
NCT07488351
The aim of this study is to evaluate the associations of self-compassion and self-efficacy levels with symptom severity, functional status, and quality of life in individuals with Parkinson's disease.
NCT07384429
The aim of this study is to explore the effects of the dual orexin receptor antagonist Lemborexant on improving motor and sleep comorbidity in patients with Parkinson's disease. This study will provide clinical evidence for the application of dual orexin receptor antagonists in the treatment of Parkinson's Disease.
NCT06006247
This is a multicenter, 12-week, placebo-controlled clinical trial of CVN424 150 milligrams (mg) tablets in early, untreated Parkinson's Disease (PD). Participants will be randomized in a 1:1 ratio to CVN424 150 mg or placebo at the Baseline Visit. The purpose of this study is to measure effect on motor features with CVN424 tablets compared to placebo in early, untreated PD and to evaluate the potential of CVN424 to improve motor and non-motor functions in participants with early PD who are not taking dopaminergic or anti-PD therapies.
NCT02119611
Background: \- In deep brain stimulation (DBS), a device called a neurostimulator is placed in the chest. It is attached to wires in parts of the brain that affect movement. DBS might help people with movement disorders like Parkinson s disease (PD), dystonia, and essential tremor (ET). Objective: \- To provide DBS treatment to people with some movement disorders. Eligibility: \- Adults 18 years and older with PD, ET, or certain forms of dystonia. Design: * Participants will be screened with medical history and physical exam. They will have blood and urine tests and: * MRI brain scan. The participant will lie on a table that slides in and out of a metal cylinder with a magnetic field. They will be in the scanner about 60 minutes. They will get earplugs for the loud noises. During part of the MRI, a needle will guide a thin plastic tube into an arm vein and a dye will be injected. * Electrocardiogram. Metal disks or sticky pads will be placed on the chest, arms, and legs. They record heart activity. * Chest X-ray. * Tests of memory, attention, concentration, thinking, and movement. * Eligible participants will have DBS surgery. The surgery and hospital care afterward are NOT part of this protocol. * Study doctors will see participants 3 4 weeks after surgery to turn on the neurostimulator. * Participants will return every month for 3 months, then every 3 months during the first year, and every 6 months during the second year. Each time, participants will be examined and answer questions. DBS placement will be evaluated with MRI. The neurostimulator will be programmed. At two visits, participants will have tests of movements, thinking, and memory....
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.
NCT07310264
This is a first-in-human (FIH) study of orally administered VT-5006 (also known as AX-5006) in healthy adult volunteers (HVs) and adult participants with Parkinson's disease (PD). The goal of this clinical trial is to learn if VT-5006 is safe and tolerable in healthy volunteers and in participants with PD. It has three Parts (A, B, and C). Part A: Healthy volunteers aged 18-54 will attend a screening visit, take a single dose of VT-5006 or matching placebo after an overnight fast, stay in the clinic for three nights, and complete a follow-up visit. One group of participants in Part A will be asked to return to the clinic after approximately two weeks, take a single dose of VT-5006 or matching placebo after consuming a high-fat meal and stay in the clinic for another three nights. Part B: Healthy volunteers aged 18-54 will attend a screening visit, take one dose of VT-5006 or matching placebo each day for seven days after fasting overnight, stay in the clinic for 10 nights, and complete a follow up visit. Part C: Participants with PD aged 40-80 will attend a screening visit, take one dose of VT-5006 (high dose), VT-5006 (low dose), or matching placebo each day for 28 days, complete two overnight stays in the clinic, attend three clinic visits, one phone call and a follow up visit.
NCT04370665
This clinical trial focus on the delivery of Cerezyme® in Parkinson's Disease (PD) patients using MR-guided focused ultrasound (MRgFUS) induced opening of the blood-brain barrier (BBB).
NCT06821230
The proposed two-arm randomized waitlist-controlled trial will use a mixed-methods design to investigate the effects of dyadic mindfulness on physio-psycho-spiritual outcomes in people with Parkinson's Disease (PwPD) and their family caregivers. One hundred Chinese patient-caregiver dyads will be randomized to receive eight weekly 90-minute dyadic mindfulness sessions or usual care. Outcome measures include negative emotions (primary outcome), patient-caregiver relationship, mindfulness, HRQOL, gut microbiome, PD-related symptoms, and caregiving burden. An actor-partner interdependence model will be used to explore the interactions of treatment effects within the dyads. The dyads will be assessed at baseline(T0), post-intervention(T1), and 4-months post-intervention(T2). The investigators will also invite 25 dyads to attend in-depth interviews exploring their experiences, perceived changes, and factors attributable to the effectiveness/ineffectiveness of the intervention. Generalized linear mixed-effects (GLME) with intention-to-treat analysis will be used to compare the changes in outcomes over time within and between the two arms. The findings will be triangulated to provide a comprehensive evaluation of the intervention's effectiveness. This study will generate rigorous scientific evidence to inform the application of dyadic mindfulness as a public health practice preventing the progression of psychological distress in PwPD and caregivers to clinically severe levels. Its self-help nature also enriches the primary care for this clinical cohort.
NCT03526991
Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using SCS has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD. The purpose of this study is to evaluate the effectiveness of spinal cord stimulation (SCS) for the management of freezing of gait (FOG) that does not respond to conventional treatments in subjects with Parkinson's disease (PD). The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD. 1. Assess the safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients. 2. Explore the effects of two SCS programming paradigms on motor, nonmotor and quality of life measures in PD patients with freezing of gait.
NCT07106242
The purpose of the study is to evaluate the efficacy of aDBS (preferred mode, single or dual threshold) vs standard continuous DBS (cDBS) in decreasing Total Electrical Energy Delivered (TEED). Prospective randomized, single-blind, crossover, multicenter study of aDBS in subjects with Parkinson's disease.
NCT07213232
The aim of the study is to examine the effects of a structured, cognitive dimension-specific cognitive training combined with dual-task balance and gait training on balance, gait, and cognition in individuals with Parkinson's disease.
NCT04701177
The study is carried out as part of the GR2021 Priority project "Healthy Brains for life (Age 20-99): Digitally-enhanced personalized medicine study ANANEOS" and code numbered GR-00546 and it will look at the decentralized and remote assessment of the symptoms of preclinical stages in Alzheimer's disease and movement disorders, e.g. Parkinson's. For this study we are looking for participants aged over 45 without cognitive complaints or with subjective perception of cognitive decline or with mild cognitive complaints. Specific aims for the proposed study: a) to develop novel sensitive measures that can provide an early identification of those SCD and MCI individuals harboring AD pathology that are at high risk of cognitive worsening over time; b) to track pre-motor stages in Parkinson's disease and trials that enable active digital functional biomarkers; c) to track disease progression during pre-dementia and pre-motor stages in clinical practice and trials with measures that enable to capture subtle changes.
NCT06671626
Humans can rapidly regulate actions according to evolving environmental demands, however, impairments of action regulation have been identified across a number of neurological disorders including Parkinson's Disease (PD). A key component of action regulation is action inhibition that occurs when stopping unwanted or inappropriate actions. There is mounting evidence that action inhibition also plays a critical part in selecting between competing alternative actions and switching to new actions in response to environmental changes. The investigators hypothesize that stop circuitry (involving frontal-subthalamic nucleus (STN) pathways) are involved in inhibiting unselected actions during action selection with competing alternatives (in the absence of overt stopping) and that switching motor plans also engages stopping circuitry (involving prefrontal-STN pathways) for cancelling the ongoing action, before changing to new one. The overall goal is to delineate the neural circuitry underlying a broad array of action regulation functions that involve inhibitory control, how these functions interrelate, and how they are implemented within brain networks. In this research, the investigator will take advantage of the unique opportunity provided by awake deep brain stimulation surgery to learn more about how the brain functions in a diseased state and how deep brain stimulation changes these networks to make movement more normal. The investigator will simultaneously assess cortical and subcortical electrophysiology in relation to clinical symptoms and behavioral measures and in response to deep brain stimulation in patients undergoing Deep Brain Stimulation (DBS) implantation surgery.
NCT03021031
The goal of this project is to provide comprehensive longitudinal assessments of a cohort of PD patients before, during, and after DBS surgery, including neurological, neurophysiological, and neuropsychological data.
