Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD
RecruitingThis study aims to determine the effects of aerobic exercise as a primer to add-on virtual reality (VR)-based rehabilitation on balance, postural control and neuroplasticity (ability of brain to adapt in structure and function) in individuals with Parkinson's disease (PD). This study will utilize two groups - one group will receive the exercise and VR, while the other group will receive stretching exercise and VR over eight weeks. The study team will administer outcomes at baseline, post-intervention (8 weeks) and follow-up (6 weeks after post-assessment).
PhaseNA
TypeInterventional
Age18 Years – 85 Years
WhereSan Antonio, Texas, United States
SponsorThe University of Texas Health Science Center at San Antonio
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
NCT07216703 · Cervical Cancer
RecruitingResearchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and * If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment
PhasePhase 3
TypeInterventional
Age18 Years
WhereMiami Beach, Florida, United States + 114 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts The purpose of this study is to ascertain the functional profiles of the immune cells within the gastrointestinal tract and to determine how these cells contribute to autoimmune and neurologic diseases.
Phase—
TypeObservational
Age18 Years – 99 Years
WhereNorth Haven, Connecticut, United States
SponsorYale University
▾Tap for detailsClick for full details — eligibility, all locations, contacts EARLY-COGN^3 - Smart Digital Solutions for EARLY Treatment of COGnitive Disability: a Neuropsychological, Neurophysiological and Neurobiological Perspective in Chronic Neurological Diseases - PNRR-MCNT2-2023-12377069
NCT06657274 · Mild Cognitive Impairment (MCI), Subjective Cognitive Complaints (SCCs),
Parkinson Disease RecruitingThe increase in life expectancy in recent decades has led to a large number of people living into old age and an increased risk of developing Chronic Neurological Diseases (CNDs) such as neurodegenerative diseases. A higher cumulative risk of dementia has been largely demonstrated in Mild Cognitive Impairment (MCI) and Subjective Cognitive Complaints (SCCs) subjects and in Parkinson's Disease (PD) patients, as compared to the general population. These disorders result in an impairment of the individual's abilities to perform daily tasks. As their disease progresses, patients become dependent on medical services and on family support. Given the limited effectiveness of pharmacological treatments, non-pharmacological interventions to prevent and treat cognitive deficits and the associated difficulties with activities of daily living in neurodegenerative disease patients have gained attention in recent years and, among these, cognitive training offers a potential approach for dementia prevention and improvement of cognitive function. A critical aspect of cognitive training programs is that the most promising interventions have involved intensive in-person sessions that are unlikely to be cost-effective or feasible for large-scale implementation. Within the framework of non-pharmacological interventions, the use of technology to assist the person at risk and/or with mild dementia at home and to extend rehabilitation services in the treatment of dementia has gradually gained importance. Telerehabilitation technologies allow to provide services remotely in patients' homes, allowing access to health care to patients living in rural settings or with mobility difficulties. In addition, the telerehabilitation modality offers the advantage of providing rehabilitation within the natural environment of the patient's home, making the treatment more realistic and possibly more generalizable to the person's daily life. The present project proposes to test a home-based asynchronous cognitive telerehabilitation program aimed at enhancing the continuum of care for MCI, SCCs and PD, using technology. The proposed study is a single blind randomized controlled trial (RCT) involving subjects with CNDs randomly assigned to one out of two intervention groups: i) the tele@cognitive group, who will receive at-home cognitive telerehabilitation (tele@cognitive treatment); ii) the Active Control Group (ACG), who will receive at-home unstructured cognitive stimulation. The aim of the project will be threefold: \[1\] to test the short-term and long-term efficacy of tele@cognitive protocol as compared to an unstructured cognitive at-home rehabilitation in the treatment of a cohort of patients with CNDs; \[2\] to explore the changes induced by tele@cognitive intervention on biomolecular and neurophysiological markers; \[3\] to explore potential cognitive, neurobiological and neurophysiological predictors of response to tele@cognitive treatment.
PhaseNA
TypeInterventional
Age18 Years – 85 Years
WhereBrescia, IT, Italy + 2 more
SponsorIRCCS Centro San Giovanni di Dio Fatebenefratelli
▾Tap for detailsClick for full details — eligibility, all locations, contacts Plasma a-Synuclein Aggregation Seeding Activity as a Novel Biomarker for Neurodegeneration Disease
NCT07498686 · RT-QuIC
RecruitingSynuclein disease, also known as Synucleinopathies, is a general term for a class of degenerative diseases. It mainly includes Parkinson's disease (PD), Dementia with lewy bodies (DLB), Multiple system atrophy (MSA) and so on. The disease is characterized by the abnormal folding of alpha-synuclein (α-syn) in the peripheral and central nervous system, resulting in the production of lewy bodies, lewy neurites, neurons, and glial cytoplasmic inclusion bodies in neurons or glial cells. The intracellular location and accumulation pattern of α-syn vary in different synuclein diseases. There are overlapping conditions between synuclein diseases, which also makes the accuracy of clinical diagnosis of synuclein diseases very low. A definitive diagnosis can be made only after the patient has died and brain samples are evaluated using immunohistochemical staining. Therefore, in order to intervene and save synuclein disease in advance, it is necessary to develop more accurate and less invasive diagnostic methods. Real-Time Quaking Induced Conversion (RT-QuIC) is a method for in vitro amplification of pathogenic protein seeds, which can enable seed proteins with in vitro amplification ability to transform substrates into misfolded seeds under specific conditions. RT-QuIC was originally used in the diagnosis of patients with prion protein. The technique can identify the prion protein in the misfolded form in the cerebrospinal fluid of patients with Creutzfeldt-Jakob disease with a specificity of 100% and a sensitivity of 95-98%, so it has been incorporated into the clinical diagnostic criteria for sporadic Creutzfeldt-Jakob disease. Studies have shown that pathogenic seeds extracted from patients' cerebrospinal fluid or other biological fluids or tissues are incubated with recombinant protein substrates, and the use of intermittent shaking to promote the interaction between the seed and substrate can force the substrate to transform into pathogenic protein seeds. The RT-QuIC reaction process is monitored in real time by a detector inside the machine for thioflavin, a fluorescent dye that fluoresces when bound to the beta lamellar layer, which is also typical of amyloid fibrils. Studies have shown that testing patients' cerebrospinal fluid with RT-QuIC can accurately distinguish lewy body dementia from non-Parkinson's dementia In this study, RT-QuIC technique was used to amplify the misfolded α-syn in clinical samples to explore the differences in protein characteristics among synuclein diseases, and to try to diagnose synuclein diseases by this method. Firstly, clinical cases of synucleoprotein disease were enrolled, and plasma of 100 control subjects, 221 cases of PD patients and 127 cases MSA patients, 10 cases of PSP patients, were established. Using RT-QuIC technology, we used aSyn (successfully prepared in our laboratory) to amplify the plasma of normal subjects and Synucleinopathies patients. It was found that the maximum fluorescence intensity (extreme value), peak time, K/2 (slope at extreme value/2) and Tmax/2 (time of reaching extreme value/2) can be used as diagnostic and differential diagnostic indicators for Synucleinopathies.
Phase—
TypeObservational
Age18 Years – 95 Years
WhereBeijing, Beijing Municipality, China + 1 more
SponsorXuanwu Hospital, Beijing
▾Tap for detailsClick for full details — eligibility, all locations, contacts It is hypothesize that patients with clinically diagnosed neurodegenerative diseases will have significantly different receptor occupancy of 5HT2A receptors compared to a healthy age/sex-matched control group. This will be tested by measuring 5HT2A receptor density using the PET radioligand (R)-\[18F\]MH.MZ in both populations.
PhasePhase 4
TypeInterventional
Age50 Years – 85 Years
WhereNashville, Tennessee, United States
SponsorVanderbilt University Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Multicontext Approach for Cognitive Function in Parkinson Disease
RecruitingMild cognitive decline is common in early Parkinson disease (PD) and is associated with disability, reduced quality of life (QOL), and increased risk for dementia. Medical treatments for PD do not prevent or treat cognitive decline and may even exacerbate the problem. Unfortunately, existing cognitive interventions for PD, which focus on restoring deficient cognitive skills through cognitive training (repetitive practice of tasks that challenge specific cognitive skills), provide limited benefit for daily function and QOL. To overcome this limitation, the investigators use strategy training. the investigators help people develop targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish daily activities. Contemporary cognitive rehabilitation evidence supports strategy training for other neurological conditions and mild cognitive impairment (MCI), but it has not been well-studied in PD. By teaching strategies for everyday cognition, the investigators hypothesize that our interventions will improve functional outcomes for people with PD. Study participants will complete a baseline cognitive testing session, 10 cognitive treatment sessions with a trained occupational therapist, then have follow-up visits with the study team at 1-week, 3-months, 6-months, and 12-months after completing the study intervention.
PhaseNA
TypeInterventional
Age50 Years
WhereSt Louis, Missouri, United States
SponsorWashington University School of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease
NCT07106021 · Idiopathic Parkinson´s Disease, Parkinson's Disease
RecruitingThis clinical trial is designed to test the safety and tolerability of the study intervention, RNDP-001, which will be implanted into the brain of study participants during a surgical procedure.
PhasePhase 1 / Phase 2
TypeInterventional
Age45 Years – 75 Years
WhereTucson, Arizona, United States + 2 more
SponsorKenai Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)
NCT05853367 · Metastatic Solid Tumors, Advanced Solid Tumors
RecruitingThe purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereChicago, Illinois, United States + 24 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts First-in-Human Single and Multiple Dose of HL-400
RecruitingThis is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics of HL-400 (a NLRP3 inhibitor) following oral single and multiple ascending dose administration.
PhasePhase 1
TypeInterventional
Age18 Years – 65 Years
WhereBaltimore, Maryland, United States
SponsorHighlightll Pharmaceutical (USA) LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease
RecruitingThe goal of this observational study is to learn if immunosuppressive drug treatment influences the clinical course of Parkinson's disease. Recent research suggests that Parkinson's disease may have an inflammatory background. Numerous studies have identified elevated levels of pro-inflammatory markers in people with Parkinson's disease. Therefore, immunosuppressive drugs may potentially affect the course of this disease. The investigators will recruit people with Parkinson's disease, who receive long-term immunosuppressive treatment for other chronic illnesses, into the study group. The study will also recruit people with Parkinson's disease with no history of immunosuppressive drug treatment into the control group. The main question this study aims to answer is: \> Does immunosuppressive drug treatment slow down the onset and/or progression of Parkinson's disease? Researchers will compare Parkinson's disease progression rates and serum inflammatory marker levels between the study and control group, to see if immunosuppressive drug treatment influences the course of Parkinson's disease. The study requires each participant to attend one hospital appointment. This appointment will be approximately one hour long, and will involve: 1. clinical Parkinson's disease motor assessments conducted by the research team -\> participants will be evaluated in the OFF state, meaning they will not have taken their Parkinson's disease medication the day of the assessment; 2. completion of Parkinson's disease symptom scales; 3. a one-time serum sample collection; 4. detailed medical history obtainment from the participant by the research team, with a primary focus on the patient's immunosuppressive treatment history and individual clinical course of Parkinson's disease.
Phase—
TypeObservational
AgeAny
WhereWarsaw, Poland
SponsorMedical University of Warsaw
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pain in Parkinson's Disease: Exploration of the Serotonin System in Positron Emission Tomography (PET [18F]-MPPF)
RecruitingThis project will explore the involvement of the serotonin system in the pathophysiology of PD-related central pain. Thus, the serotonin system will be evaluated in PD patients with and without central pain who will benefit from brain positron emission tomography (PET) allowing in vivo imaging of 5HT1A receptors and multimodal brain MRI including morphometric imaging and functional connectivity (resting state acquisition).
PhaseNA
TypeInterventional
Age40 Years – 80 Years
WhereToulouse, Haute-Garonne, France
SponsorUniversity Hospital, Toulouse
▾Tap for detailsClick for full details — eligibility, all locations, contacts Abbott DBS Post-Market Study of Outcomes for Indications Over Time
NCT04071847 · Movement Disorders,
Parkinson Disease, Essential Tremor
RecruitingThe purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.
Phase—
TypeObservational
AgeAny
WhereTucson, Arizona, United States + 47 more
SponsorAbbott Medical Devices
▾Tap for detailsClick for full details — eligibility, all locations, contacts Simplified, Scalable, 24-hour Adaptive DBS in Parkinson's Disease
RecruitingThe purpose of this study is to test a new way to treat Parkinson's disease (PD). Subjects will be implanted with deep brain stimulator (DBS) devices and electrodes placed under the scalp. The main questions it aims to answer are: * Is there a less invasive method to collect useful brain signals? Find out if these brain signals can be related to movement and/or sleep symptoms. * How to use these brain signals to tailor adaptive deep brain stimulation settings for movement and/or sleep symptoms Researchers will compare study derived adaptive DBS settings to subject's clinically programmed continuous DBS settings to see which is better at treating patients PD symptoms.
PhaseNA
TypeInterventional
Age18 Years
WhereSan Francisco, California, United States
SponsorUniversity of California, San Francisco
▾Tap for detailsClick for full details — eligibility, all locations, contacts Patients referred to neurosurgery routinely and safely undergo deep brain stimulation (DBS) for treatment of neurological conditions, most commonly Parkinson's disease. The investigators have observed that respiratory problems (breathlessness) sometimes occur subsequent to DBS of the subthalamic nucleus (STN). This study aims to determine whether this is indeed a consequence of STN stimulation. Secondary objectives include identification of the respiratory physiological mediators of any interoceptive neuromodulation observed, changes in daily physical activity and MRI structural connectivity analysis.
Phase—
TypeObservational
Age18 Years
WhereOxford, Oxfordshire, United Kingdom
SponsorUniversity of Oxford
▾Tap for detailsClick for full details — eligibility, all locations, contacts Long-term Longitudinal Imaging of Presynaptic Terminals in PD
RecruitingAIM: To investigate whether SV2A loss spreads from brainstem to cerebral cortex with progression of Parkinson's disease (PD) and to determine whether longitudinal cortical SV2A loss correlates with cognitive decline in PD. STUDY DESIGN: The investigators will re-invite participants (both patients with PD and healthy controls) of a previous longitudinal study (NCT04243304, S61477) to undergo evaluation approximately 7 years after the initial baseline study visit (i.e. on average 10 years since the first motor symptoms). All participants will undergo clinical assessment of motor and non-motor symptoms (including cognitive testing), as well as 11C-UCB-J PET-CT (targeting synaptic density marker SV2A), 18F-FE-PE2I PET-CT (targeting DAT) and brain MRI.
PhaseNA
TypeInterventional
Age30 Years
WhereLeuven, Belgium
SponsorUniversitaire Ziekenhuizen KU Leuven
▾Tap for detailsClick for full details — eligibility, all locations, contacts RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
NCT07002034 · Adjustment Disorder
RecruitingThe purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.
PhasePhase 2
TypeInterventional
Age18 Years – 80 Years
WhereBirmingham, Alabama, United States + 29 more
SponsorReunion Neuroscience Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy of Split Gait in the Treatment of Dynamic Asymmetries in Subjects With Pathologic Claudication
NCT04635436 ·
Multiple Sclerosis, Poststroke/CVA Hemiparesis,
Parkinson Disease RecruitingWalking on a split-belt treadmill (each of the two belts running at a different speed) imposes an asymmetrical gait, mimicking limping that has been observed in various pathologic conditions. This walking modality has been proposed as an experimental paradigm to investigate the flexibility of the neural control of gait and as a form of therapeutic exercise for hemi-paretic patients. However, the scarcity of dynamic investigations both for segmental aspects and for the entire body system, represented by the centre of mass, challenges the validity of the available findings on split gait. Compared with overground gait in hemiplegia, split gait entails an opposite spatial and dynamic asymmetry. The faster leg mimics the paretic limb temporally, but the unimpaired limb from the spatial and dynamic point of view. These differences suggest that a partial shift in perspective may help to clarify the potential of the split gait as a rehabilitation tool. The aim of the present study is to investigate the dynamic asymmetries of lower limbs in adults with unilateral motor impairments (e.g. hemiplegia post-stroke, Parkinson's disease, multiple sclerosis, unilateral amputation, surgical orthopedic interventions) during adaptation to gait on a split-belt treadmill. The sagittal power provided by the ankle and the total mechanical energy of the centre of mass will be thoroughly studied. The time course of phenomena both during gait when the belts are running at different speed and when the belts are set back to the same speed (i.e. the after-effect) will be investigated. A greater dynamic symmetry between the lower limbs is expected after split gait. The question whether this symmetry will occur when the pathological limb is on the faster or the lower belt will be disclosed. Some alterations of the motion of the centre of mass during split gait are also expected.
PhaseNA
TypeInterventional
Age18 Years – 70 Years
WhereMilan, MI, Italy
SponsorIstituto Auxologico Italiano
▾Tap for detailsClick for full details — eligibility, all locations, contacts Improving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling
NCT06529744 · Dementia,
Alzheimer Disease, Dementia With Lewy Bodies
RecruitingTo develop a model to predict disease progression in a large cohort of patients across a variety of neurodegenerative diseases, including Mild Cognitive Impairment (MCI) and dementia due to any neurodegenerative disease, including Alzheimer's Disease (AD), Lewy Body Disease (LBD), Vascular Disease (VaD) and Frontotemporal lobar degeneration (FTLD).
Phase—
TypeObservational
Age30 Years – 95 Years
WhereNorth York, Ontario, Canada + 3 more
SponsorUniversity Health Network, Toronto
▾Tap for detailsClick for full details — eligibility, all locations, contacts Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting
NCT07410598 ·
Parkinson Disease, Deep Brain Stimulation
RecruitingThe primary objective of the proposed pilot study is to assess the safety and tolerability of active patterned Deep Brain Stimulation (pDBS) when administered in a home setting for patients with Parkinson's disease (PD) who have had stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS.
PhaseNA
TypeInterventional
Age18 Years – 80 Years
WhereGainesville, Florida, United States
SponsorUniversity of Florida
▾Tap for detailsClick for full details — eligibility, all locations, contacts