Active clinical trials for "Parkinson Disease"

The aim of this study is to assess the safety and the potential efficacy of personalized Local Field Potential (LFP)-based adaptive Deep Brain Stimulation (aDBS), using the implantable pulse generator (IPG) of the "AlphaDBS" System, in Parkinson's Disease patients, chronically implanted in subthalamic nucleus (STN) for DBS, at the time of IPG replacement.

The purpose of this study is to compare the effectiveness of the deep brain stimulation of asymmetric targets [subthalamic nucleus (STN) in the right hemisphere while globus pallidus interna (GPi) in the left] versus the bilateral STN for the treatment of Parkinson's disease (PD) with postural instability/gait difficulty (PIGD) in a randomized, double-blinded manner.

Considering that Parkinson's Disease (PD) can significantly compromise functional mobility and cardiovascular system in patients with PD, therapies aimed at improving these aspects, mainly by non-pharmacological and non-invasive methods, are paramount. This clinical trial will study the acute effects of plantar stimulation using a therapy called automated peripheral mechanical stimulation (AMPS) on cardiovascular and functional mobility in patients with PD. The hypothesis of this study is that one single session will be effective in improving, acutely, the cardiovascular system and functional capacity in patients with PD.

The purpose of this study is to investigate the optimal stimulation location of transcranial direct current stimulation to improve the dual-task performance in patients with Parkinson's disease.

Gait difficulties are common in Parkinson's disease (PD) and cause significant disability. No treatment is available for these symptoms. Spinal Cord Stimulation (SCS) has been found to improve gait, including freezing of gait, in a small number of PD patients. The mechanism of action is unclear and some patients are nonresponders. With this double-blind placebo-controlled proof of concept and feasibility imaging study, we aim to shed light on the mechanism of action of SCS and collect data to inform development of a scientifically sound clinical trial protocol. We also hope to identify imaging biomarkers at baseline that could be predictive of a favourable or a negative outcome of SCS and improve patient selection. Patients will be assessed with clinical rating scales and gait evaluations at baseline and 6 and 12 months after SCS. They will also receive serial 18F-FDG and ([18F]FEOBV) PET scans to assess the effects of SCS on cortical/subcortical activity and brain cholinergic function

Multimodal non-invasive neuromodulation paired with physical therapy is a promising treatment modality for Parkinson's Disease ("PD"), however the optimal stimulation method, dose, and associated therapeutic protocol for long-lasting clinical benefits have not yet been identified for this population. Here the investigators aim to develop and execute a preliminary clinical study exploring the potential benefits of multimodal non-invasive neuromodulation. The therapeutic intervention will involve translingual neurostimulation +/- galvanic neurostimulation, paired with an intensive physical and cognitive therapy program.

This study is aimed at testing the hypothesis that adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Investigators will directly test the efficacy of an adaptive stimulation protocol. Study subjects are adults with Parkinson's disease who experience inadequate motor symptom relief, and who have been offered implantation of a deep brain stimulator system targeting STN for the treatment of motor symptoms (standard-of-care). Investigators will implant 20 (n = 10 per clinical site) Parkinson's Disease subjects with the Medtronic RC+S System, enabling the implementation of real-time adaptive stimulation during in-home sleep. Prior to surgery, study subjects will complete clinical sleep questionnaires in an outpatient setting and wear an actigraphy watch for 3 weeks to monitor sleep architecture and sleep fragmentation. Three months after subjects have completed their standard-of-care Deep Brain Stimulation surgery and are optimized in terms of Parkinson's medication and clinical DBS stimulation parameters, we will monitor sleep for an additional 3 weeks, using in-home monitoring. During each week of the in-home monitoring period, subjects will undergo, in a randomized and double-blind fashion, one of three nocturnal stimulation algorithms: Adaptive stimulation, Open-Loop stimulation (standard clinical stimulation therapy) and No stimulation (control). During the 3 weeks of in-home sleep monitoring, we will monitor sleep architecture and sleep fragmentation using an actigraphy watch and subjects will complete a sleep questionnaire. At the end of the 3-week period of sleep-time randomized, blinded stimulation delivery, subjects will return to their standard stimulation therapy.

This open-label study is designed to assess the long-term safety and tolerability of dipraglurant in PD patients for up to 52 weeks (at doses of 150-300 mg per day) for patients that have completed an Addex sponsored double-blind clinical trial of dipraglurant.

The purpose of this study is to assess the effectiveness of the visual cues of a wearable device in preventing freezing of gait (FOG) in those with PD.The aim is to investigate the impact of laser shoe attachments on gait in single and dual-tasking scenarios, as well as "real-world" mobility scenarios, in people with PD who freeze. For this study, participants will wear sensors on their feet, hips, chest, and head to show stride length, foot angle, and foot height, and head position during different gait assessments. The patients will do the gait assessments without the laser shoes and with the laser shoes to determine how the laser shoes affect freezing of gait. The gait assessments include having the patient complete a two minute walk, two minute walk with another task (reciting every other letter of the alphabet), obstacle course, obstacle course with another task (reciting every other letter of the alphabet), and quickly turning in place. The assessments are activities that are performed in everyday activities so there are no risks associated with these requested tasks. These activities will be done in a lab at the Phoenix Biomedical Campus. Safety for the participants will be monitored by placing a belt around the waist of the participant with a member of the research personnel close by in case the participant demonstrated a shift in their balance. The research member can use the belt to provide stability and secure the participant, preventing them from further loss of balance. Moreover, three different activities of daily living (ADL's) will be assessed with and without the laser shoes in a simulated apartment environment located at the Phoenix Biomedical campus. The ADL's include walking from the bed to the kitchen, walking from the living room to the kitchen and making tea in the microwave, and answering the door. The activities to be done in the apartment setting will be video-recorded and analyzed. Some participants will be given the laser shoes to take home and use for one week. The same protocol explained above will be used to assess freezing of gait after this one week in those selected participants. To assess retention of improvements, the participants who took the laser shoes home will also be given the same protocol two days later (after not having used the laser shoes during that time). Participants will also complete surveys for quality of life, freezing and gait and cognitive function. A standard test for balance will also be conducted.

The main goal of PD research is to develop disease-modifying drugs to delay or prevent the underlying neurodegenerative process. Levodopa, as the gold standard for PD treatment, is associated with the occurrence of motor complications. Many previous studies have confirmed that Stalevo can reduce the side effects of levodopa alone. Moreover, the effects of Stalevo on the treatment of PD patients have been extensively studied, but the efficacy of Stalevo in early PD patients has been less studied. Therefore, it is necessary to further study the treatment of early PD with Stalevo, and observe whether increasing the number of medication can reduce the occurrence of dyskinesis. The research results will help to deepen the understanding of Stalevo in the treatment of early PD and its clinical efficacy.