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Parkinson's Disease - ClinicalTrials.gov

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Last Updated: 27 April 2022

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Imaging Biomarkers in Parkinson Disease

Part 1: In a case-control analysis, compare brain images of PD patients and healthy volunteers using various imaging techniques. Part 2: Compare results on serial brain images with clinical assessments of clinically defined PD subjects, subjects with prodromal Parkinson disease, and healthy volunteers over the past nine years. The patients with chronic disease and prodromal signs will have insight into how imaging results evolve over time, and their connection with disease progression; the patients with prodromal syndromes will reveal which imaging techniques/analysis may reveal PD's clinical manifestations; healthy volunteers will serve as controls for subjects aging and technological transitions as a result of scanner operation. Part 2 : Over the next nine years, we will continue to research qualifying subjects from Part 1 regularly. For up to 9 years, we will also investigate 38 patients who follow the MDS prodromal PD guidelines for up to 9 years. Clinical presentation: We'll see how the prodromal signs influence clinical PD's progression to clinical PD. Structural MR : The outcome measurements are the changes in gray and white matter morphometry within groups and within groups as time progress. FMRI results are the difference in resting state functional connectivity patterns as shown by BOLD signal shifts and their dynamics within organizations and time. MRS: The outcome measure for MRS is the difference in the amplitude of phosphorus-containing compounds and neurotransmitters in sensorimotor cortices and basal ganglia between groups and time.

Source link: https://clinicaltrials.gov/ct2/show/NCT01496599


Hereditary Parkinson Disease Natural History Protocol

The overwhelming majority of people with Parkinson's Disease have lived in the 7th and 8th decades of life. Both the genetic and degenerative disorders can be helped by our knowledge of the genetic causes of early onset Parkinson's Disease early in life. Patients with EOPD also have a variable age of onset and disease penetrance at the same time. The hypothesis we propose is that the number and allele distributions of EOPD susceptibility gene mutations account for the variability in age of onset and disease penetrance. This hypothesis will be tested in this natural history protocol by genotyping people with EOPD to identify their genetic abnormalities and determine the cellular reparative function in these individuals using peripheral blood cells, skin biopsy derived fibroblasts, and induced pluripotent stem cells derived from these individuals.

Source link: https://clinicaltrials.gov/ct2/show/NCT02511015


Biomarkers of Risk of Parkinson Disease

Prcise Objective: By the time an individual experiences motor disease or signs of Parkinson disease, the degeneration of nigrostriatal dopaminergic neurons that causes the movement disorder has already begun. During the follow-up, researchers with multiple risk factors, such as central or myocardial catecholaminergic neurodegeneration, are diagnosed with motor signs and signs of PD within 7. 5 years of follow-up, but not with motor symptoms and signs of PD are not diagnosed with motor symptoms and signs of PD. What percentage of at-risk subjects with negative biomarkers at the time of initial testing show signs of PD after 7. 5 years of follow-up? What percentage of at-risk patients with 1 or 2 positive biomarkers at the time of initial testing have the motor signs and symptoms of PD? During the 7. 5 years of follow-up? What percentage of homeless patients who go from negative to positive biomarkers during the re-up period, as well as the previous period of 7. 5 years of follow-up? Outcome Measures: The primary outcome measure is a clinical diagnosis of PD by a board-certified neurologists who is blinded to risk factor analysis and the findings of catecholaminergic biomarkers testing; or else, a 7. 5-year follow-up without a diagnosis of PD.

Source link: https://clinicaltrials.gov/ct2/show/NCT00775853


Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3

This report is a Phase 3 multi-site, randomized, evaluator-masked investigation of endurance treadmill exercise on changes in the MDS-UPDRS Part III score at 12 months. At 12 and 18 months, Tertiary experiments related to two ambulation characteristics will be tested. At 24 months, the exercise effects will be tested by experimental hypotheses relating to the consequences of removing the study support that was offered over 18 months on the endurance and longevity of the exercise effects will be tested. Approximately 29 sites will enroll: 27 sites in the United States and two sites in Canada that cover all geographic areas of the country and two sites in Canada.

Source link: https://clinicaltrials.gov/ct2/show/NCT04284436


UAB Neuroinflammation in Parkinson's Disease - TSPO-PET Substudy

In participants of the UAB Neuroinflammation in Parkinsons Disease study, the primary aim of this subgroup is to determine the presence and distribution of activated brain microglia/macrophages in regional brain matrices. [18F]DPA-714-PET/MRI] The primary aim of this research is to find out if patients with PD have higher rates of neuroinflammation than healthy controls.

Source link: https://clinicaltrials.gov/ct2/show/NCT03457493


Characterizing Biomarkers of Early Parkinson's Disease Progression

Parkinson's disease is the second most common neurodegenerative disorder worldwide, and although both motor and non-motor symptoms can be improved with symptomatic therapies, there are currently no drugs that slow or halt progression of the disease. Plan: Participants in a cohort of 25 untreated PD patients with motor testing and blood sampling performed at baseline and at 6 months will travel to Portland, Virginia, over a 12 month period. With difference, the VA lab will perform whole blood for metabolic CBC with differential. In BLDG 103 - E143, the research team will collect blood samples from the VA phlebotomist to Dr. Quinn's VA lab. Using Ficoll-Paque, peripheral blood mononuclear cells will be isolated from buffy coats.

Source link: https://clinicaltrials.gov/ct2/show/NCT03716258


Investigating Inhibitory Control Networks in Parkinson's Disease

Movement disorders are a common cause of disability worldwide. Response inhibition, or the inability to avoid a habitual behaviour, is one of the most debilitating cognitive deficits. PD patients have a difficult time with RI and its contribution to lowering their quality of life. Although some studies show that dopamine can improve this aspect of cognitive function, several patients are severely impaired. With gait dysfunction, falls, and gait freezing, RI may have contributed to motor impairment. Deep brain stimulation, although a highly effective treatment for motor manifestations, is ineffective for, and may even exacerbate cognition, with no research currently focusing on how different settings can enhance NMS. The investigators intend to investigate RI in patients with mobility disorders and correlated movement and cognition with underlying neural electrophysiology before and during tasks of mobility and response inhibition in order to begin addressing these debilitating features of PD. This allows acute, intraoperative testing for therapeutic use and side effects, as well as providing insight into how a patient will react to the therapy once the cranial electrode is connected to the battery and turned on. While patients perform various tasks, it is possible to correlate behavioral function and neural performance by monitoring brain activity in the outer layers as well as the DBS electrode itself. Several others also have research paradigms in place to achieve these targets by laying a subdural strip electrode over cortex prior to inserting the DBS lead.

Source link: https://clinicaltrials.gov/ct2/show/NCT04735458


Walking and mHealth to Increase Participation in Parkinson Disease

Parkinson disease is one of the most common chronic health disorders affecting older adults around the world. Despite the year's relative lack of motor impairments, prior studies showed that people with PD saw a 12% decrease in the amount of walking over a year. Walking, the most rapidly evolving area of disability in PD, may have the greatest influence on reducing disability and decreasing disability. In this study, the investigators suggest a paradigm shift in which the primary goal of the intervention is real-world walking habits, as more walking can help with walking efficiency and disability. Psychological rather than physical appearance are the key factors that discourage participation in walking in PD. Physical therapists are matched to people with PD using a smartphone health app to create plans to increase self-confidence and enable goal-oriented, fun walking habits, and walking enhancing exercises for over a year. Investigators speculate that the mHealth group will have elevated walking output and increased walking capacity relative to the control group. With regard to the software that underlies the change in walking capacity over a year, it is expected that self-efficacy would mediate shifts in the amount of walking and that changes in the amount of walking will mediate changes in walking speed.

Source link: https://clinicaltrials.gov/ct2/show/NCT03517371


Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease

Sleep disturbances are one of the most common non-motor signs of PD; approximately two-thirds of PD patients suffer with sleep disorders of some sort. Given that sleep plays a role in the regulation of several bodily functions, sleep disruption has a major effect on quality of life in PD and places a strain on caregivers. Although deep brain stimulation is primarily used to relieve PD motor symptoms and minimize the need for dopaminergic drugs, several studies have found that DBS improves non-motor signs, including sleep disturbances. In PD, only few studies have used an objective measure to determine the effects of DBS on sleep, and none have done so by investigating sleep in the home environment. Both patients' usual medication regimen and those withholding medications will be tested before DBS implantation, as well as withholding medications.

Source link: https://clinicaltrials.gov/ct2/show/NCT05348837

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions