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Parkinson Disease clinical trials

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NCT ID: NCT05357612 Recruiting - Parkinson Disease Clinical Trials

Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases

Start date: January 23, 2023
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05356845 Completed - Clinical trials for Parkinsonian Disorders

Oral Health, Orofacial Function and Oral Health Care in Patients With Parkinson's Disease

Start date: May 3, 2021
Phase:
Study type: Observational

Introduction: Problems with oral health (dental and oral diseases) as well as orofacial function (jaw opening, chewing and salivation problems) are significant challenges for many people with Parkinson's disease (PD). These challenges may be painful, disabling, and cause great psychosocial strain and negatively affect quality of life. Furthermore, they may contribute to an unsecure and unhealthy aging, because eating and enjoyment of food is important for both the physical and psychological wellbeing for elderly and chronically ill patients. It seems that patients with PD often find it difficult to maintain adequate oral hygiene and fail to visit the dentist, which in the end contributes to tooth loss, eating problems, poorer nutrition, social challenges and reduced quality of life. To be able to plan interventions on a larger scale more detailed knowledge and mapping is necessary on the extent of various manifestations of PD in the orofacial area, the affect on the patients and their quality of life, and how the disease develops in the orofacial area for the patient group over time. The study will clarify the challenges and problems that patients with PD have due to their disease in terms of dental and oral health and function of mouth and jaws. Such information is important both for single patients with respect to prevention and intervention and for development of community health strategies. Purpose - to investigate specific orofacial, non-motor and motor symptoms and functions as well as the oral microbiome in patients with PD compared to a control group. - to examine the quality of life related to oral health in the abovementioned groups. - to provide information on the orofacial problems in PD for the benefit of single patients with respect to prevention and intervention and for development of community health strategies. Hypotheses: It is expected that - patients with PD have more orofacial functional problems and poorer oral health than a control group without PD, and patients with late PD have more orofacial functional problems and poorer oral health than patients with early PD. - patients with PD have an altered oral microbiome compared to a control group without PD, which possibly may assist in the staging of PD. - patients with PD have poorer oral health related quality of life and home dental care than a control group without PD.

NCT ID: NCT05355480 Recruiting - Parkinson Disease Clinical Trials

Handwriting Analysis in Movement Disorders

HANDWRML
Start date: December 1, 2022
Phase:
Study type: Observational

Handwriting is a complex cognitive prowess that deteriorates in patients affected by neurodegenerative diseases, including movement disorders. More in detail, patients with Parkinson's disease (PD) may manifest prominent handwriting abnormalities which have been collectively identified as parkinsonian micrographia. MIcrographia may manifest at the onset of the disease and then worsens progressively with time. Previous techniques released to investigate micrographia in PD relied on perceptual analysis of simple tasks or were based on expensive technological tools, including tablets. However, handwriting can be promptly collected in an ecological scenario, through safe, cheap, and largely available tools. Also, the objective handwriting analysis through artificial intelligence would represent an innovative strategy even superior to previous techniques, since it allows for the analysis of large amounts of data. In this experimental project, the investigators apply a specific machine learning algorithm to analyze handwriting samples recorded in healthy controls and PD patients. The study aims to verify whether the technique proposed by the investigators would be able to detect parkinsonian micrographia objectively, monitor the evolution of handwriting abnormalities and assess the symptomatic improvement of handwriting following L-Dopa administration in PD patients.

NCT ID: NCT05355064 Not yet recruiting - Parkinson Disease Clinical Trials

Efficacy of Oral Administration of Trehalose in Patients With Parkinson Disease

Start date: May 2022
Phase: Phase 4
Study type: Interventional

Parkinson's disease (PD) is a neurodegenerative disease characterized by the neurodegeneration of substance nigra pars compacta (SNpc) and the formation of alpha-synuclein protein aggregates in neurons. Although most PD patients are sporadic, it is now clear that genetic factors contribute to the pathogenesis of PD. Indeed, LRRK2 G2019S mutation is one of the most common causes of familial PD. The phenotype corresponding to this mutation is a late-onset form of PD characterized by the accumulation of the N-ethylmaleimide sensitive factor (NSF) in neurons. It is due to a dysfunction of the physiological autophagy processes occurring at cellular level, mainly affecting autophagy mediated by chaperone proteins (Chaperon Mediated Autophagy, CMA), responsible for the clearance of alpha synuclein at the lysosomal level. This condition, although sensitive to treatment with L-DOPA and dopamine agonists, does not currently have any specific therapy. Recently, in a mouse model carrying the LRRK2 mutation, it has been demonstrated that treatment with trehalose is able to reduce the accumulation of NSF deposits in neurons of various brain areas such as the substantia nigra, striatum, cortex and hippocampus. The reduction of protein aggregates correlates with intracellular molecules related to the activation of apoptotic processes in damaged neurons. Moreover, it has been found a significant improvement in motor and cognitive performance. The aim of the present study is to evaluate the safety and tolerability of trehalose in two groups of patients affected by idiopathic PD and PD carrying the LRRK2 mutation, respectively. Moreover, the investigators will collect preliminary data on the effect that this molecule potentially has on disease course in both groups. The treatment duration will be 24 weeks and the overall study duration approximately 12 months. The populations observed will be composed of subjects affected by idiopathic PD and familial PD carrying the genetically confirmed LRRK2 mutation. Enrolled subjects will daily take trehalose in oral administration. Safety will be assessed by detecting any adverse events and analyzing blood chemistry parameters. The effect of trehalose will be evaluated through periodic clinical examinations, including the administration of specific scales and questionnaires.

NCT ID: NCT05353959 Recruiting - Parkinson Disease Clinical Trials

Progression Follow up of the First-degree Relatives of Patients With REM Sleep Behavior Disorder

Start date: January 3, 2022
Phase:
Study type: Observational

REM sleep behavior disorder is a novel and distinct parasomnia characterized by recurrent dream enactment behaviors (DEBs) and polysomnographic features of REM sleep without atonia (RSWA), with typical onset age at early 60's. Idiopathic RBD (iRBD) has been suggested as a most specific precursor of α-synucleinopathy-related neurodegeneration (e.g. Parkinson's disease (PD)). There are increasing reports of positive familial cases in both iRBD and PD. In the past few years, the investigators have established the baseline data of a case-control family cohort of iRBD (208 first-degree relatives (FDR) of patients with iRBD and 204 FDRs of controls). Not only did the investigators confirm the familial aggregation of iRBD with neurodegeneration and iRBD cases, the investigator also found that the FDRs harbored a spectrum of isolated RBD features (including DEBs, REM- sleep behavioral events, and RSWA). Besides, when compared with control-FDRs, iRBD-FDRs patients showed more prodromal markers of neurodegeneration (including possible/probable RBD, excessive daytime sleepiness, constipation, and subthreshold parkinsonism) as suggested by the International Parkinson and Movement Disorder Society (MDS) research criteria. The promising baseline findings paved the way for the current proposed prospective study of this unique family cohort. In addition, around 85 unaffected FDRs from each group has repeated the assessments at a mean follow-up duration of about 4 years (early termination of the study supported by RGC- ECS Ref no. 24117018; reason for early termination - ECS PI applicant left the University at early 2020), the preliminary data indicated a persistent familial aggregation of RBD symptoms, loading of prodromal markers (e.g. possible RBD, subthreshold parkinsonism), and a seemingly faster progression into prodromal RBD among the FDRs of iRBD than that of control. This current proposed study is a prospective study with a mean of 7-year follow-up interval to monitor the progression of α- synucleinopathy neurodegeneration and related markers. With the rolling recruitment, the investigators now have 230 control-FDRs and 250 iRBD-FDRs, from which the investigators expect 200 FDRs of each group may respond to the follow-up study. A series of prodromal markers related to neurodegeneration including clinical and sleep assessment (e.g. autonomic symptoms, motor signs, neurocognitive function, sleepiness, vPSG and one-week actigraphy) that were measured at baseline will be reassessed. Specifically, home PSG with a body-movement monitoring system will be additionally implemented in the proposed study to empower the identification of RBD features, especially during the COVID pandemic period at which hospital accessibility is restricted. In addition, the development of clinical neurodegenerative diseases will be ascertained. This proposed study, by recruiting FDRs of iRBD patients (and controls) with prospective study design, will provide novel and important information on the progression of prodromal makers of α-synucleinopathy neurodegenerative diseases in a high-risk population and facilitate further genetic/omics and future neuroprotective intervention study of the familial iRBD.

NCT ID: NCT05353855 Recruiting - Parkinson Disease Clinical Trials

Neural Correlates of Impulsivity in Idiopathic REM Sleep Behavior Disorder

Start date: January 1, 2022
Phase:
Study type: Observational

This study aims to investigate the neural correlates (structural changes, functional connectivity, and structural connectivity of brain structures in prefrontal cortex and basal ganglia) of impulsivity by measuring structures and the blood-oxygen-level-dependent signal of brain in response to impulsive tasks and task-free using functional Magnetic Resonance Image method among healthy controls, patient with prodromal PD (iRBD), and patients with PD.

NCT ID: NCT05353764 Recruiting - Parkinson Disease Clinical Trials

Effect of Scalp Nerve Block on the Recovery Quality of Parkinson's Patients After Deep Brain Stimulation

Start date: April 20, 2022
Phase: N/A
Study type: Interventional

Patients diagnosed with Parkinson's disease (PD) undergoing deep Brain Stimulation (DBS) have a higher risk of perioperative complications and postoperative pain will affect quality of recovery (QoR) resulting in longer hospitalization time and higher hospital costs. Scalp nerve block (SNB) combined with intercostal nerve block (ICNB)can alleviate postoperative pain while effect of them on postoperative recovery quality of patients diagnosed with PD was unclear. Therefore, the investigators conducted a randomized controlled trails to provide a novel method for enhanced recovery and early prevention and treatment of acute pain after DBS surgery.

NCT ID: NCT05353517 Recruiting - Parkinson Disease Clinical Trials

Non-invasive Assessment of Synaptic Plasticity

NEUROPLAST
Start date: December 1, 2022
Phase:
Study type: Observational

The pathophysiological mechanisms underlying Movement Disorders, including Parkinson's disease, have been related to altered synaptic plasticity affecting several structures of the central nervous system. Although several previous neurophysiologic investigations have shown abnormal long-term potentiation and depression-like plasticity in M1, other regions crucially involved in motor planning and execution, including the spinal cord, have been studied less. Parkinson's disease arises from the progressive loss of dendritic spines followed by atrophy of specific cortical (i.e. M1) and subcortical structures (i.e. putamen). These structural changes are responsible for the main clinical features of PD such as bradykinesia and rigidity. The present research project aims to probe non-invasively the main pathophysiologic mechanisms underlying altered synaptic plasticity in M1 and spinal cord and their relationship in a cohort of patients with movement disorders, including Parkinson's disease. More in detail, the investigators will use specific methodologies able to induce plasticity, including the repetitive transcranial magnetic stimulation (TMS), concerning the M1 and the focal muscle vibration, regarding the spinal cord. The neuromodulation protocol will imply 2 separate sessions, randomly scheduled to take into account the effect of the symptomatic pharmacologic treatment. Furthermore, patients will be randomly assigned to sham or real non-invasive stimulation groups. Before and after the stimulation protocol, the investigators will collect specific clinical as well as neurophysiologic measures (i.e., thresholds) according to standardized procedures. In conclusion, the goal of the study is to investigate the abnormal plasticity in the M1 and spinal cord in patients affected by specific movement disorders, through non-invasive techniques.

NCT ID: NCT05351580 Active, not recruiting - Parkinson Disease Clinical Trials

DiSCERN: Advanced PD Therapy Candidacy and Evaluation System

DiSCERN
Start date: July 21, 2022
Phase:
Study type: Observational

To collect data to develop models that identify when patients with advanced Parkinson's disease (PD) are not responding well to their current therapy and may be ready to consider advanced therapy and when patients receiving advanced therapy are not responding well and need a therapy adjustment.

NCT ID: NCT05350709 Not yet recruiting - Parkinson Disease Clinical Trials

Action Observation Therapy and Mirror Therapy in Parkinson's Disease

Start date: April 25, 2022
Phase: N/A
Study type: Interventional

Small muscles of the hand are affected due to involuntary movements and slowing of voluntary movements seen in Parkinson's disease. There is a loss of fine dexterity and coordination in the hand. It becomes difficult for patients to grasp and release of the objects. They become unable to perform daily activities such as buttoning up, holding keys, brushing teeth, holding forks, spoons and glasses, and writing. Therefore, a certain part of the rehabilitation program should be devoted to upper extremity rehabilitation. The aim of this study was to compare the effects of action observation therapy and mirror therapy, which have been used in the literature for many years, on upper extremity functions and quality of life in individuals with Parkinson's disease.