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Parkinson Disease clinical trials

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NCT ID: NCT05110053 Recruiting - Parkinson Disease Clinical Trials

Spinal Cord sTimulation thEraPy for Parkinson's Disease Patients With Gait Problems

STEP-PD
Start date: September 1, 2021
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT05109364 Recruiting - Clinical trials for REM Sleep Behavior Disorder

Terazosin and Parkinson's Disease Extension Study

Start date: September 23, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the long-term effects of treatment with the selective post-synaptic a1-adrenergic blocker terazosin on serial in a population of subjects with defined pre-motor Parkinson's disease (PD) risks and abnormal imaging exams. Imaging changes will be correlated to the presence and severity of motor and non-motor symptoms of PD, measured by validated clinical scales and cardiac autonomic function tests.

NCT ID: NCT05106504 Recruiting - Parkinson Disease Clinical Trials

Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease

Start date: September 2, 2021
Phase:
Study type: Observational

Medical cannabis (MC) is a standard treatment in Israel to Parkinson's disease (PD) patients suffering from pain. Nevertheless, it is not known about MC effectiveness for other non-motor symptoms of the disease. Our aim is to prospectively observe patients with PD before and after initiation of MC, for non-motor symptoms effect. In specific, relying of data from multiple sclerosis patients and basic science showing cannabinoid receptor 1 (CB1) is abundantly expressed in the sub epithelial layer of the bladder, we will explore the impact of MC on bladder function and urinary symptoms.

NCT ID: NCT05103384 Recruiting - Parkinson Disease Clinical Trials

Utilizing Neural Signatures and Virtual Reality to Advance DBS Programming

Start date: July 22, 2022
Phase:
Study type: Observational

The project uses virtual reality technology to recreate situations that cause freezing of gait in individuals with Parkinson's disease. Individuals who underwent deep brain stimulator (DBS) surgery for Parkinson's disease will walk through a virtual reality environment while brain signals are recorded from the DBS device. The goal is to better understand what occurs in the brain during freezing of gait.

NCT ID: NCT05103072 Recruiting - Parkinson Disease Clinical Trials

Subthalamic Nucleus Stimulation With Directional Leads on Patients With Parkinson Disease at Fluctuations and Dyskinesia Stage

NSTBOS
Start date: September 21, 2021
Phase:
Study type: Observational

Patients with subthalamic nucleus have to go through a lot of examinations and tests, before and after surgery which is difficult, sometimes painful, for the patient. The investigators used to chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator. The investigators can chose the plot using a software (Guide Xt), which can delete the exhausting test. The investigators would like to study the non inferiority of this tool to choose the best plot .

NCT ID: NCT05101161 Recruiting - Parkinson Disease Clinical Trials

Neurofeedback Using Implanted Deep Brain Stimulation Electrodes

Start date: September 23, 2021
Phase: N/A
Study type: Interventional

Deep brain stimulation (DBS) has become a gold-standard symptomatic treatment option for Parkinson's disease (PD) and is also explored for a variety of other neurological disorders. The implantation of electrodes into deep brain areas has not only enabled the application of electrical stimuli, but has also provided researchers and clinicians with an unprecedented window to investigate aberrant neuronal activity right at the core of pathological brain circuits. Local field potentials (LFP) have already been readily investigated through externalised DBS electrode wires prior to internalisation and connection to an implantable neurostimulator. In the case of PD, motor symptoms have been evidenced to correlate with exaggerated beta oscillatory activity (13-35 Hz) in the LFP recorded from the subthalamic nucleus (STN). Firstly, beta activity recorded in the STN at rest in patients withdrawn from their medication has been correlated with the Unified Parkinson's Disease Rating Scale (UPDRS) across patients. Secondly, a reduction of signal power in the beta-band was correlated with clinical improvements of motor symptoms. Thirdly, the two main therapeutic strategies, the administration of L-Dopa, and high-frequency DBS both lead to a suppression of beta-synchronicity in the STN. Furthermore, beta-oscillations show fast and movement-dependent modulation over time and can serve as a biomarker and feedback signal to control the delivery of DBS. The investigators recently implemented deep brain electrical neurofeedback to provide real-time visual neurofeedback of pathological STN oscillations through externalised DBS electrodes and showed that PD patients were able to volitionally control and reduce subthalamic activity within a single 1 hour session. Moreover, neurofeedback-learnt strategies accelerated movements and could be retained in the short- and mid-term. Only recently, a newly developed neurostimulator, the Percept™ PC (Medtronic Neurological Division, Minneapolis, MN, USA), has been clinically approved, which can not only apply electrical impulses, but also enable the measurement and transmission of brain activity. This neurostimulator is now the first choice for implantations at the University Hospital Zurich and is used for a variety of neurological disorders. The investigators' goal is to investigate whether neurofeedback through a fully implanted deep brain stimulation device is possible and can lead to a better control of pathological oscillations as well as symptom mitigation. Having shown that endogenous control over deep brain oscillations is possible, the investigators will also test this novel therapeutic approach for pathologies other than PD that are also treated with DBS. Neurofeedback using implanted DBS electrodes will have the advantage of enabling longer and multiple-day training sessions, which the investigators hypothesise to have a larger impact on control over pathological deep brain oscillations and neurological symptoms, as such a fully implanted neurofeedback system no longer requires the externalisation of DBS wires and is as such no longer limited to the first two days after electrode implantation. All in all, the investigators will not exceed a total streaming time of 7 hours per patients (7 d of battery time), which the investigators deem justifiable with respect to a battery life of > 5 years. This proposed research is highly significant as it will help our understanding of various neurological diseases that are highly prevalent in society (PD being, for instance, the second most common neurodegenerative disorder after Alzheimer's disease) and might culminate in novel, endogenous treatment strategies. The overall risk for patients is minimal to non-existent, as stimulation parameters are unaffected and the intended changes in brain activity are self-induced while DBS stimulation is off.

NCT ID: NCT05094219 Recruiting - Parkinson Disease Clinical Trials

Disease Burden and Cost Consequence of Falls Among Individuals With Parkinson's Disease in Hong Kong: A Prospective Cost-utility Analysis

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

Objective: Estimate the cost of disease and falls among people with Parkinson's disease living in Hong Kong. Design: Prospective cost-utility analysis (base year 2021) with one baseline and two follow-up assessments at 6 months and 12 months Participants: Community-dwelling participants with Parkinson's disease of both genders of any age. Intervention: Nil Outcome measures: Self-reported questionnaires will be used to obtain information about the healthcare utility. In addition, the number of falls, the severity of Parkinson' disease assessed using the MDS-Unified Parkinson's Disease Rating Scale, level of disability using the Hoehn and Yahr scale, balance using the Mini Balance Evaluation Systems Test and Activities-specific Balance Confidence (ABC) scale, risk of falls using Falls Efficacy Scale International and quality of life using the Short-form Health survey (SF-36) will be assessed. Predictors of cost include fall frequency, balance status, disease severity, level of disability, quality of life, and duration of disease. Analysis: A multiple regression analysis will be conducted to determine which predictor (independent variable) influence the overall cost. The level of statistical significance (α) will be set at p<0.05. A Tornado plot will be constructed for the individual items of both direct and indirect cost having the minimum and maximum range set at the 25th and 75th percentile. Two-way analysis of variance (ANOVA) will assess the differences in healthcare cost among frequent, in-frequent and non-fallers. Spearman's or Pearson correlation coefficient will assess correlations between quality of life and healthcare cost; disease severity and healthcare cost; falls frequency and healthcare cost. Benefits to healthcare and health Cost-estimation highlights information required to enhance the health care service for the target population. Through a similar study among patients with cerebellar ataxia, our team demonstrated specific challenges that need additional support from the policy-makers such as employment following disability, visits to specialists, home-care, and community participation for people with cerebellar ataxia in Hong Kong. This study will highlight the strength and weakness of the current healthcare system to people of Hong Kong with Parkinson's disease, this will inform the challenges for the healthcare requiring additional attention which in turn will have a beneficial impact on the future service.

NCT ID: NCT05084365 Recruiting - Parkinson Disease Clinical Trials

A 6-month Study to Evaluate Sulforaphane Effects in PD Patients

Start date: November 28, 2021
Phase: Phase 2
Study type: Interventional

Parkinson's disease (PD) is a second common neurodegenerative disease. More than 6 million individuals worldwide have Parkinson disease. No disease-modifying pharmacologic treatments are available. Current medical treatment is symptomatic, focused on improvement in motor (eg, tremor, rigidity, bradykinesia) and nonmotor (eg, constipation, cognition, mood, sleep) signs and symptoms. Accumulating evidence suggests the important role for inflammation and oxidative stress in the pathogenesis of PD. Sulforaphane extracted from broccoli sprout is an agent with potent anti-oxidant and anti-inflammatory activity. Previous studies suggested sulforaphane is useful in dopaminergic neuron survival. In this study, the investigator attempts to evaluate the efficacy and safety of sulforaphane in PD patients.

NCT ID: NCT05073874 Recruiting - Parkinson Disease Clinical Trials

Attentional Focus and Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease (PD)

AttPark
Start date: December 8, 2021
Phase: N/A
Study type: Interventional

Attention may influence the motor performance and frontal activity. This study will examine the effect of different attentional focus: internal, external and divided attention (dual task) on prefrontal cortical activation (fNIRS) and on gait performance. Thirty older adults and thirty PD will participate in this study.

NCT ID: NCT05070013 Recruiting - Parkinson's Disease Clinical Trials

Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease (Aim 2)

Start date: November 18, 2021
Phase: N/A
Study type: Interventional

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.