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Parkinson Disease clinical trials

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NCT ID: NCT05478057 Not yet recruiting - Parkinson Disease Clinical Trials

Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Speech disturbance is common in patients with Parkinson disease. Pharmacotherapy improves motor symptoms but has inconsistent effects on speech disturbance in PD patients. Transcranial magnetic stimulation (TMS) is a safe and non-invasive tool used for brain stimulation. Repetitive transcranial magnetic stimulation (rTMS) has positive effects on motor function of PD. Yet, its effect on speech disturbance seems to be inconclusive. Previous rTMS studies mainly focused on the primary motor cortex for PD speech disturbance. Nevertheless, we think supplementary motor area (SMA) may be a better target. Speech disturbance in PD may be associated with basal ganglia-thalamocortical motor circuits and SMA involves in the cortex part. In addition, neuroimaging studies showed that SMA were under-activation in PD patients. Therefore, we conduct this 3-year study including two experiments. The aim of the study is to determine if rTMS over SMA can improve the speech function of PD patients and change the functional connectivity of speech pathway in the brain. This will be the first study to investigate the effect of rTMS over SMA on speech.

NCT ID: NCT05477654 Not yet recruiting - Parkinson Disease Clinical Trials

Motor-cognitive Dual-task in Healthy Older Adults and Early Parkinson's Disease Patients

TwinBrainPD
Start date: August 1, 2022
Phase:
Study type: Observational

Neuromuscular dysfunction is common in older adults and even more pronounced in neurodegenerative diseases. In Parkinson's disease (PD), a complex set of factors often prevents effective performance of activities of daily living that require intact and simultaneous performance of motor and cognitive tasks. In the current study we aim at employing the Mobile Brain/Body Imaging approach (MoBI) to gain further insides of neuromuscular biomarkers revealing the decrements of older adults with an early PD. The cross-sectional study will be evaluated through the multifactorial mixed-measure design.

NCT ID: NCT05456451 Not yet recruiting - Parkinson Disease Clinical Trials

Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease

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

Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release. In this study, it was aimed to investigate the effects of non-invasive vagus nerve stimulation to be applied to patients with Parkinson's disease on tremor and vagus nerve activity in patients. The tremor and autonomic activations of the participants will be evaluated at pre and post treatment.

NCT ID: NCT05453331 Not yet recruiting - Parkinson Disease Clinical Trials

Asleep MRI-guided Versus Awake Microelectrode Recording Guided Deep Brain Stimulation in Parkinson's Disease: A Comparative Effectiveness Trial

ACCURATE
Start date: October 2022
Phase:
Study type: Observational

Rationale: Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a well-accepted treatment for Parkinson's disease (PD). Traditionally, the procedure is performed awake and under local anaesthesia to facilitate intraoperative monitoring via microelectrode recording and test stimulation for exact electrode positioning. Advances in MR imaging allow for clear visualization of the STN and therefore direct targeting. Retrospective series suggest that MRI-guided and image (CT or MRI)-verified STN-DBS under general anaesthesia yields a similar motor outcome and quality of life (QoL) as awake and microelectrode recording-guided surgery with intra-operative clinical testing. MRI-guided and image (CT or MRI)- verified approach potentially has advantages in terms of patient experience and cost-effectiveness. The study proposed here is the first in the world to directly compare both methods. Objective: To compare bilateral MRI-guided and CT-verified STN-DBS under general anaesthesia to awake microelectrode-guided bilateral STN-DBS with intra-operative clinical testing in terms of motor improvement. Study design: A multicentre comparative effectiveness trial with a non-inferiority design. Study population: 158 PD people eligible for bilateral STN-DBS (79 in each arm). Intervention: This study compares two modalities of standard treatment. One arm receives awake microelectrode recording guided bilateral STN-DBS under local anaesthesia with intraoperative clinical testing. The other arm receives MRI-guided and CT-verified bilateral STN-DBS under general anaesthesia. Main study parameters/endpoints: The primary outcome is the change from baseline to one year in Unified Parkinson's Disease Rating Scale part III (UPDRS III) scores (OFF Medication) versus the postoperative scores (OFF medication and ON stimulation). Secondary objectives include patient experience, quality of life, adverse effects and complications, neuropsychological examination, non-motor symptoms (including psychiatric evaluation), reduction in anti-parkinsonian medication, activities of daily living (ADL) functioning and cost- effectiveness.

NCT ID: NCT05435755 Not yet recruiting - Parkinson's Disease Clinical Trials

Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease.

Start date: December 2, 2022
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of multiple treatments of hAESCs treatments, while exploring the effectiveness of hAESCs treatments for PD.

NCT ID: NCT05414071 Not yet recruiting - Parkinson Clinical Trials

Clinical Investigation of NMS Assist

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

Parkinson's can cause a wide range of non-motor symptoms (NMS), including pain and problems with mental health, memory and sleep. These affect the quality of life of people with Parkinson's (PwP) and their care partners (CP). If these issues are not recognised and managed quickly, they can result in escalating problems. Many PwP are unsure of the extent and variety of the NMS and how simple adjustments at home could improve them. We have developed a digital system, NMS Assist, to help PwP monitor their non-motor symptoms and develop skills to self-manage them. Such a tool needs to be simple to use, safe and effective. We will ask 60 PwP, CP and members of their Parkinson's healthcare team to use NMS Assist for 12 months, and we will monitor how they use the tool. PwP and CPs will be asked if they feel more knowledgeable and confident to manage their own symptoms whilst being better able to discuss a problem with their healthcare professional. A smaller group of the participants will discuss their experiences in more detail to help pinpoint aspects that work well and those needing adjustment and development. Members of the healthcare team will be asked to assess any improvement in communication with PwP and CPs. It is thought that the use of this system will result in improved quality of life and increased knowledge and confidence for managing symptoms while safely reducing the time spent by health care professionals on manageable non-motor symptoms.

NCT ID: NCT05410769 Not yet recruiting - Parkinson Disease Clinical Trials

Compassion Program for Parkinson

Start date: July 2022
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) is a chronic and progressive neurodegenerative disease of the central nervous system. Second only to Alzheimer's in incidence on the population, Parkinson's disease has a negative impact on the quality of life of both patients and caregivers. Despite the prevailing attention to motor symptoms, such as bradykinesia, tremor and rigidity, the typical Parkinsonian symptom includes a wide range of non-motor symptoms that invalidate various aspects of the patient's autonomy, cognitive, behavior and mood that impact on patients' quality of life and that of caregivers.

NCT ID: NCT05405933 Not yet recruiting - Parkinson Clinical Trials

Comparison of Propioceptive Neuromuscular Facilitation Vs Balance Exercise Along With Conventional Therapy for Balance and Gait in Chronic Parkinson's Patient

Start date: June 2022
Phase: N/A
Study type: Interventional

To determine the effect of Proprioceptive Neuromuscular Facilitation Vs Balance Exercise along with Conventional Therapy for balance and gait in Chronic Parkinson's patients.

NCT ID: NCT05402163 Not yet recruiting - Parkinson Disease Clinical Trials

CANadian Adaptive DBS TriAl

CANADA
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Parkinsonian symptoms, such as freezing of gait (FOG) or hypophonia, play a significant role in reducing quality of life for Parkinson disease (PD) patients, and are poorly responsive or can worsen with deep brain stimulation (DBS). Repeated adjustments of stimulation parameters may be beneficial however, continuous DBS (cDBS) does not adapt to the patients' rapidly fluctuating clinical status and does not take into account reliable and consistent state-trait biomarkers. These biomarkers can be recorded by the electrode itself as local field potentials (LFP). These LFPs can be used to guide stimulation output by means of a 'closed loop' or 'adaptive' DBS (aDBS). This is a pilot, two-phase, double-blinded, cross-over study of chronic Adaptive vs. Continuous STN DBS in patients with PD by using a novel implantable DBS system that can automatically adjust stimulation parameters based on the patient's clinical condition. The study will test the hypothesis that aDBS stimulation will treat motor fluctuations similarly to continuous stimulation but it will be superior to the latter in the treatment of speech, gait impairment and falls.

NCT ID: NCT05384522 Not yet recruiting - Parkinson Disease Clinical Trials

Analysis of the Prognostic Role of Epigenetic Biomarkers in Relation to the Motor Decline in Parkinson's Disease

BioGenPark
Start date: May 30, 2024
Phase:
Study type: Observational

BioGenParkinson is an observational, prospective cohort study evaluating biomarkers of Parkinson's Disease (PD) progression in community-dwelling subjects aged 65 years or more, consecutively referring to INRCA outpatient clinic of the Neurology Unit. Selected patients will undergo clinical and laboratory evaluations at the baseline, and will be followed up after 6 and 12 months. The biological evaluation will include the determination of i) routine biological parameters ii) advanced biomarkers such as epigenetic analysis of DNA methylation, genetic analysis on multiple loci associated with PD progression and specific proteins associated with motor and non-motor decline. After obtaining all data, multiple statistical analysis will be performed to evaluate the most accurate prognostic biomarkers of PD progression at this stage of disease.