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Parkinson Disease clinical trials

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NCT ID: NCT05922046 Not yet recruiting - Parkinson Disease Clinical Trials

The Impact of Virtual Reality on Upper Limbs at Different Ages of Subjects With Parkinson's Disease

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

ntroduction: Parkinson's disease (PD) is characterized as a neurodegenerative disorder associated with progressive loss of dopamine in the basal ganglia region, resulting in classic motor symptoms such as bradykinesia, rigidity, postural instability and tremor. Such symptoms end up affecting the functionality of the upper limbs (MMS) in this population. In recent years, Virtual Reality (VR)-based therapy has been gaining popularity, but studies in the area are still lacking. Objective: To verify the benefits of virtual reality in individuals with PD above 65 years of age and in individuals below 65 years of age in the functionality of the upper limbs and to identify possible differences between them. Methodology: This is a randomized clinical trial, in which the evaluators will be separated into two experimental groups (single-blind). Subjects with PD will be randomized into two groups: Group Over 65 years of age (GI1), and Group below 64 years of age (GI2). Both will receive treatment with virtual reality games in a non-immersive environment (flat screen) through the Leap Motion Controller (LMC) device. Both treatments will focus on large and fine upper limb tasks, in a protocol with 4 activities and duration of approximately 27 minutes, twice a week, for eight weeks. The two groups will be evaluated in three moments: before the intervention and immediately after 8 weeks. They will be analyzed at the ADL level, through the TEMPA test and part II of the unified PD assessment (MDS-UPDRS II); motor assessment (part III) of the MDS-UPDRS and motor staging of PD (Hoehn & Yahr); manual dexterity through the Box and Block test and the Nine Hole Peg Test; cognition by Montreal Cognitive Assessment (MoCA); quality of life through the PD questionnaire (PDQ-39); the usability of the system (SUS); and possible side effects (Simulator Sickness Questionnaire). It is expected that this study will show that the treatment applied to the younger population presents better results when applied to the older population.

NCT ID: NCT05882487 Not yet recruiting - Parkinson Disease Clinical Trials

Safety and Efficacy Study of KL002 in the Treatment of Advanced Primary PD

Start date: June 1, 2023
Phase: Early Phase 1
Study type: Interventional

This is a non-randomized, open label, dose-escalation study to evaluate the safety and efficacy of KL002 in the treatment of advanced primary Parkinson's disease. Condition or disease: Parkinson's Disease Intervention/treatment: Drug: KL002 Phase: NA

NCT ID: NCT05855577 Not yet recruiting - Parkinson Disease Clinical Trials

Motor Function Efficacy of Pharmacological Treatments Targeting Energy Metabolism, in Parkinson's Patients

Start date: December 2023
Phase: Phase 4
Study type: Interventional

Consistent evidence suggests that mitochondrial dysfunction plays a crucial role in Parkinson¿s disease pathogenesis. Inhibition of complex I of the mitochondrial electron transport chain is sufficient to reproduce biochemical and pathological features of Parkinson¿s Disease in animal models (PD). Alterations of mitochondrial energy metabolism may intervene in PD pathogenesis by inducing inflammation, generation of reactive oxygen species (ROS), and neurodegeneration. The Nuclear factor erythroid 2-related factor 2 (Nrf2) is a regulator both of mitochondrial function and biogenesis, and of cellular resistance to oxidative stress, and may represent a novel target of PD disease-modifying therapies. The aims of the present study are to validate indicators of energy metabolism as biomarkers in PD patients and to evaluate the efficacy of drugs and natural food supplements acting on the Nrf2 pathway in improving motor impairment and Gait in PD patients.

NCT ID: NCT05854524 Not yet recruiting - Parkinson Disease Clinical Trials

Exercise Neuroprotection in Parkinson's Disease

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

This purpose of this study is to explore the relationships of exercise on inflammation in the body in older adults and people with Parkinson's disease (PD). This is important research for older adults and but is especially important for people with PD because neuroinflammation is the main pathological mechanism that is responsible for neuron cell death in this neurodegenerative disease. As PD is a progressive disease, halting or slowing the degeneration is an important research target. Halting or slowing the disease progress is known as neuroprotection. Exercise is an attractive therapeutic treatment for people with PD as it has a lot of multi-systemic benefits but also there is a lot of evidence to suggest that it helps improve symptoms and slow the progression of the disease. Exercise has been theorized to decreased inflammation and, therefore, has a lot of promise as a neuroprotective agent in slowing or halting the degeneration in PD. Unfortunately, there is not a lot of research that has looked into the effect of exercise on the biological processes of inflammation. Thus, the purpose of this study is to investigate the biological evidence that underlies the positive effect of exercise in people with PD.

NCT ID: NCT05839821 Not yet recruiting - Parkinson Disease Clinical Trials

Rhythmic Auditory Stimulation on Neural Activity During Finger-tapping in PD Patients

Start date: June 1, 2023
Phase:
Study type: Observational

Introduction Bradykinesia (i.e., slow movements) is one of the most prominent symptoms of Parkinson's disease (PD) and has a negative impact on quality of life. Rhythmic auditory stimulation (RAS), a widely used and promising treatment technique, has been shown to effectively improve gait speed in PD patients. However, only few studies have explored effects and neural mechanisms of RAS on upper-limb movements. The investigators will conduct two studies to investigate effects and mechanisms of RAS on upper-limb movements in PD patients. The purpose of this study is to examine real-time neural activity when patients with PD and healthy controls listen to RAS and execute finger-tapping task simultaneously. Methods and analysis This study will recruit patients with PD and healthy controls. Electroencephalography (EEG) will be used under six conditions related to a finger-tapping task. Two-way repeated measures analysis of variance will be performed to investigate the group and condition effects on neural mechanisms. Study significance This study will offer evidence on RAS effects and mechanisms by investigating the changes in upper-limb movements and neural mechanisms during auditory-motor entrainment. Results from this study will provide a solid foundation for further research and clinical applications of RAS.

NCT ID: NCT05837715 Not yet recruiting - Parkinson Disease Clinical Trials

Effects of Cervical Stabilization Exercises and Vibration Application in Individuals With Parkinson's Disease

Start date: August 30, 2023
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) is the second most common neurodegenerative disease that causes a progressive decrease in motor functions, which is caused by the influence of dopaminergic pathways in the substantia nigra (SN). Motor and non-motor symptoms seen in PD seriously affect patients negatively. Proprioception, which is one of the deep senses, is known to help maintain body verticalization in the sense of posture and movement and has a primary importance in the regulation of motor activities. Depending on the progression of the disease, flexion of the body is triggered as a result of the deterioration of proprioception over time. It is suggested that the losses in proprioception may result from the inability to properly regulate motor control and body reflexes. Therefore, the assessment of proprioception plays an important role in assessing changes in postural instability, gait and fall risk. It is said that while peripheral muscle feedback is preserved in Parkinson's patients, there is deterioration in integration in the central. Changes in the supraspinal processing of proprioceptive input in PD have been demonstrated by analyzing the effect of mechanical vibration applied to the tendon of a stretched muscle during voluntary movements. Vibrator stimulation activates muscle spindle afferents, particularly primary endings. It is also stated that muscle feedback is not only related to the movement performed, but also to the response induced by vibration. In line with this information, vibration applications have been added to the treatment of PD in recent years with the aim of stimulating postural adjustments through the application of an external proprioceptive input. It is selectively used in neurological rehabilitation because of the effect of local vibration training on spinal excitability. When the literature is examined, it has been determined that the studies on the effects of local vibration applied to the neck region on posture, balance, proprioception and other sensory profiles are insufficient, especially in individuals with Parkinson's disease. In this project, it is aimed to guide professionals working with Parkinson's disease in the management of this disease by determining the effects of cervical stabilization and local vibration application to the cervical region on motor symptoms and sensory profile in individuals with Parkinson's disease.

NCT ID: NCT05837520 Not yet recruiting - Parkinson Disease Clinical Trials

i-BiSSkApp for Swallowing Rehabilitation in Parkinson's Disease

Start date: June 15, 2023
Phase: Phase 1
Study type: Interventional

Aspiration pneumonia due to dysphagia is a leading cause of death in Parkinson's disease (PD). Dysphagia intervention in the United States involves evaluation at onset of dysphagia symptoms followed by short-term therapy. Traditional therapy relies on verbal instruction and low-tech at-home exercise regimens without visual biofeedback; lacking a monitoring of accuracy or strength of exercise. Available biofeedback is office-based, bulky and expensive, thus, not readily used. The Biofeedback in Strength and Skill Training (BiSSKit) is a well-researched office based biofeedback system that has recently been converted into an affordable and accessible home-based application. This study aims to investigate the impact of swallowing therapy using the BiSSKit app on airway protective outcomes in patients with PD. Thirty participants with PD and dysphagia will be recruited for this study. Participants will undergo a baseline-modified barium swallowing (MBS) evaluation followed by 12 weekly sessions of swallowing therapy. Participants will be randomized to two swallowing therapy groups (1) traditional (2) BiSSKit app. Participants will undergo MBS following therapy completion. Outcome measures include swallowing safety, pharyngeal kinematics, and swallowing-related quality of life. We hypothesize that use of the BiSSKit will result in improved swallowing function compared to the traditional swallowing therapy group.

NCT ID: NCT05822739 Not yet recruiting - Parkinson's Disease Clinical Trials

Safety and Efficacy Study of Parkinson's Disease Gene Therapy Drug (BBM-P002)

Start date: April 28, 2023
Phase: Early Phase 1
Study type: Interventional

Safety and Efficacy Study of BBM-P002 in subjects with primary advanced Parkinson's disease

NCT ID: NCT05822258 Not yet recruiting - Parkinson Disease Clinical Trials

DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial Measurement Units

DetectFoG
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Parkinson's disease is the second most common neurodegenerative disease in the world. One of these manifestations is the freezing of gait (FOG) which affects 50 to 80% of Parkinsonian patients. It is defined as a brief and episodic absence or marked reduction in the forward progression of the feet despite the intention to walk. FOG is one of the most disabling symptoms causing a greater risk of falling and a loss of autonomy for these patients. This symptom is little or not dopamine-sensitive and little improved by surgery (deep brain stimulation). Although this symptom is common and debilitating, it is difficult to assess clinically. The objective assessment of the presence and severity of FOG episodes can be done with tests such as the New-Freezing of Gait Questionnaire (N-FOGQ) with however limitations. Indeed, this filmed examination is scored a posteriori and the accumulation of the administration times which makes it difficult to use in routine clinical practice. To overcome these limitations, the use of a diary completed by the patient himself is a simple alternative to assess this symptom, but studies show that patients abandon this practice in the long term and that it is not used by patients with cognitive impairment. Recent advances in miniaturization have made it possible to create light and compact sensors to assess these events objectively. Inertial measurement units have been widely used in the literature to detect FOG episodes. The choice of the detection algorithms are a major issue in the scientific community. To date, due to the heterogeneity of the protocols, no method is currently required as a reference. The objective is to evaluate the accuracy of a new algorithm to detect the number of FOG episodes in Parkinsonian patients. This evaluation will be done on the freeze-inducing walking path.

NCT ID: NCT05818189 Not yet recruiting - Parkinson Disease Clinical Trials

Cortical Correlates of Gait in Parkinson's Disease: Impact of Medication and Cueing

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

The purpose of the study is to determine the effects of a novel, personalized, tactile cueing system on gait automaticity. The researchers hypothesized that step-synchronized tactile cueing will reduce prefrontal cortex activity (improve automaticity) and improve gait variability (as well as gait speed). The researchers predict that improved automaticity with improved gait variability will be associated with increased activation of other than prefrontal cortical areas while walking (i.e., sensory-motor). To determine the effects of cueing, 60 participants with PD from will be randomized into one, of two, cueing interventions: 1) personalized, step-synchronized tactile cueing and 2) tactile cueing at fixed intervals as an active control group. In addition, the researchers will explore the feasibility and potential benefits of independent use of tactile cueing during a week in daily life for a future clinical trial. This project will characterize the cortical correlates of gait automaticity, the changes in gait automaticity with cueing in people with Parkinson's Disease, and how these changes translate to improvement in gait and turning. The long-term goal is to unravel the mechanisms of impaired gait automaticity in Parkinson's Disease.