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Parkinson Disease clinical trials

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NCT ID: NCT06447207 Not yet recruiting - Parkinson Disease Clinical Trials

Occupational Therapy Led Social Prescription for People With Parkinson Disease

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Loneliness is an epidemic that the U.S. Surgeon General implored must be addressed by society as a whole. Increased loneliness (i.e., distressing feelings of isolation) in people with Parkinson's disease (PD) has a pervasive impact and is associated with worsened motor and non-motor symptoms, and quality of life. The investigators expect that individuals participating socially in the community would experience less loneliness. However, for individuals with PD participating in community-based group exercise programs, the investigators have found that over one third still report being lonely. Therefore, an evidence-based program needs to be added to address a significant problem of loneliness for people with PD-and occupational therapy is the leading discipline to add the intervention because social participation is one of eight occupations that an occupational therapist is focused on optimizing. The chief executive officer at the Parkinson Association of the Rockies (PAR), members of the Colorado State University Occupational Therapy Department, and members of the University of Colorado's Parkinson's Exercise Research Consortium have teamed up to address pervasive loneliness. Social prescription is a prime evidence-based intervention to add to existing PD community-based exercise classes because it has been shown to reduce loneliness. For this project, the investigators detect participants in the 'lonely' range through a standardized assessment. The investigators will work with PAR staff who will refer individuals identifying as 'lonely' to an occupational therapist, who will complete an individualized occupational profile and write the appropriate social prescription from 11 different interventions (examples include: intergenerational intervention, animal companions, physical activity, occupational therapy) from established community resources recommended for social prescription. The proposed project is designed with three primary goals: (1) determine the reach of the social prescription program, (2) evaluate the effectiveness of the program at one site, and (3) determine implementation strategies for scalability.

NCT ID: NCT06444789 Not yet recruiting - Parkinson Disease Clinical Trials

AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)

dBM-DEV
Start date: July 15, 2024
Phase:
Study type: Observational

dBM-dev study is a multicentre low-intervention research study which concerns REM sleep behaviour disorder (RBD) who is the best predictor for neurodegenerative diseases including Parkinson's disease (PD). RBD can only be confirmed by polysomnography, which is a cumbersome procedure. The main objective of this study is to identify a novel, robust dBM for the detection of RBD using smartwatch-based recordings of passive data.The study is conducted step-wise on two subsequent cohorts referred to as the development cohort and the confirmation cohort.

NCT ID: NCT06442033 Not yet recruiting - Parkinson Disease Clinical Trials

Genetics and Aerobic Exercise to Slow Parkinson's Disease Trial

GEARS
Start date: June 15, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The proposed multi-site, Genetics and Aerobic Exercise to Slow PD (GEARS) Trial will, for the first time, determine the interplay between genetics and exercise in altering PD progression. In sum, 200 PD patients will be recruited from the Cleveland and Salt Lake City metro areas to participate in the Pedaling for Parkinson's (PFP) community-based exercise program. Participants will exercise at community-based sites 3x/week for 12 months. All participants will undergo genotyping using an array that includes the genome backbone and common risk variants associated to increase risk for multiple neurological disorders including PD.

NCT ID: NCT06438419 Not yet recruiting - Parkinson Disease Clinical Trials

Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range

MOVOSCILLCBGT
Start date: June 2024
Phase: N/A
Study type: Interventional

Expression of hypokinetic and hyperkinetic motor symptoms in Parkinson's disease (PD) is associated with pathological synchronous oscillations of neuronal activity (local field potential/LFP) in the cortico-subcortical network with a wide frequency range. In the present project, we propose to study cortico-subcortical oscillations and their synchronization in patients operated for PD (subthalamic deep brain stimulation (STN-DBS)) during distinct pharmacological and stimulation conditions (hypokinetic and hyperkinetic), using a simple motor task.

NCT ID: NCT06431971 Not yet recruiting - Parkinson Disease Clinical Trials

Estimates of the Short-term Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease

Start date: August 2024
Phase: Phase 2
Study type: Interventional

This study is double-blinded placebo controlled to estimate the short-term efficacy of Talineuren. The investigational Medicinal Product (IMP) is administrated 18 times intravenously as an add-on therapy to the standard of care Parkinson medication. Talineuren is a liposomal formulation containing GM1 (monosialotetrahexosylganglioside) as the pharmacological active substance. The results of this pilot study are essential for the sample size calculation of a subsequent larger phase II/III trial.

NCT ID: NCT06425731 Not yet recruiting - Parkinson Disease Clinical Trials

Dance and Energy Expenditure Among Adults With Parkinson's

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The first purpose of the study is to develop and test new methods for quantifying dance among adults with a diagnosis of Parkinson's using various kinds of cameras, wearable activity monitors, and questionnaires. The second reason we are conducting the study is to better understand the relationship between the intensity of dance classes specifically designed for adults with Parkinson's and individual-level factors like the kinds of routine activities one does beyond dancing and one's health status. Participants in the study may be asked to engage in any of the following activities: - complete a small number of assessments on their physical and cognitive functioning - complete their routine group-based dance classes, specifically designed for adults with a diagnosis of Parkinson's, while being recorded Depending upon the group that a participant joins, one may also be asked to: - wear an activity monitor on their waist while engaged in their daily business as usual for nine (9) days - complete an iDXA scan - describe their perceptions on how the use of technology can integrated into their dancing

NCT ID: NCT06422208 Not yet recruiting - Parkinson Disease Clinical Trials

Autologous iPSC-Derived Dopamine Neuron Transplantation for Parkinson's Disease

Start date: June 2024
Phase: Phase 1
Study type: Interventional

This research study is evaluating an investigational cell product called autologous induced pluripotent stem cell (iPSC)-derived dopamine neurons. This research study is a single-center Phase 1 clinical trial, which will test the safety of injecting the investigational cell product into the brain of subjects with Parkinson's disease.

NCT ID: NCT06418802 Not yet recruiting - Parkinson Disease Clinical Trials

Study of the Effects of STN-DBS on Gait in Parkinson's Disease.

Start date: June 2024
Phase: N/A
Study type: Interventional

Objectives: Parkinson's disease (PD) is the second most common degenerative disease of the nervous system. Postural instability/gait disorder (PIGD) is one of the motor symptoms of Parkinson's disease, which affects the quality of life of patients with Parkinson's disease. At present, deep brain stimulation(DBS)can significantly improve tremor and bradykinesia, but whether deep brain stimulation is effective for gait disorders is still a controversial topic. In addition, the previous gait assessment mainly focused on scales or simple walking tests, and appropriate and effective evaluation methods are needed to evaluate the efficacy of intervention for gait disorders in PD patients. Therefore, in view of these problems, this study will use wearable devices and traditional scale evaluation to explore the effects of deep brain stimulation on gait in patients with Parkinson's disease. Methods: A total of 30 patients with Subthalamic nucleus DBS(STN-DBS)were expected to be enrolled. By adjusting the parameters of STN-DBS (voltage, frequency, pulse width), the effects of different parameters on PD gait were compared. Gait changes were mainly analyzed by wearable devices and MDS Unified Parkinson's Disease Rating Scale assessment(MDS-UPDRS). The (Timed Up and Go)TUG test, narrow channel task, circle task and trajectory analysis were performed in the unmedicated state. The wearable device was used to collect the motion information of 10 different positions of the human body, including the wrist, thigh, ankle, foot tip, chest and waist nodes. (1)Experiment 1: Patients were divided into pre-operation group and post-operation group. A case-control study was conducted, and patients were followed up at 1 month,3 months,6 months and 1 year after operation. (2)Experiment 2: This study was a single-center, randomized, double-blind, crossover trial of deep brain stimulation with a short pulse width (30s) versus conventional pulse width (60 s) in PD patients with bilateral STN-DBS. Gait data and MDS-UPDRS were collected at baseline, after 4 weeks and 8 weeks. (3)Experiment 3: By adjusting the frequency parameters of STN-DBS (30,100, and 130HZ), gait data and MDS-UPDRS were collected after 10 minutes of the washout period, and the best DBS parameters for gait improvement were maintained for 4-8 weeks and then evaluated again. Expected results: By adjusting the parameters (voltage, frequency, and pulse width) of STN-DBS, the potential mechanisms for improving gait disorders in PD were explored, meaningful digital biomarkers for PD gait prognosis were explored, and long-term programming of STN-DBS was guided.

NCT ID: NCT06416722 Not yet recruiting - Parkinson Disease Clinical Trials

Telerehabilitation Dual-Task Training for Parkinson's: A Multidimensional Evaluation

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

In this clinical study, the aim is to assess the effectiveness of telerehabilitation-based dual-task training in improving balance and gait function among individuals diagnosed with Parkinson's Disease. Parkinson's Disease is characterized by motor symptoms such as tremors and slowness of movement, as well as cognitive impairments. While medical treatments help manage symptoms, exercise programs are vital for enhancing physical and cognitive functions. Dual-task training involves combining motor and cognitive activities to enhance gait and balance control, and recent studies have shown its effectiveness in Parkinson's Disease rehabilitation. However, there's limited research on delivering dual-task training through telerehabilitation and determining the optimal content for maximum benefits. This project involves 30 Parkinson's Disease patients who will be randomly assigned to three groups receiving different dual-task exercise programs via telerehabilitation. Each program focuses on combining balance and functional exercises with either cognitive or motor secondary activities. The exercises will be performed three times a week for four weeks under the guidance of a physiotherapist via Zoom. Before and after the intervention, participants will be evaluated for feasibility, gait, balance, cognition, and activity levels. Researchers of this study hypothesize that telerehabilitation-based dual-task training will significantly improve balance and gait function in Parkinson's Disease patients, offering a convenient and effective treatment option to enhance their quality of life.

NCT ID: NCT06416345 Not yet recruiting - Parkinson Disease Clinical Trials

Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The majority of people with Parkinson's disease incur Freezing of Gait (FoG), which is not addressed adequately by medication. Cueing is a proven strategy to overcome FoG. The Cue2Walk is a device with automated detection of FoG and provision of rhythmic cues. In this study, the (cost-)effectiveness of the Cue2Walk device as compared to usual care is investigated.