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546 active trials for Parkinson Disease

Safety and Efficacy of State-of-the-Art Exoskeleton Technology to Improve Mobility in Parkinson's Disease

The purpose of this study is to test the safety and efficacy of using of a portable exoskeleton for walking training in persons with Parkinson's disease that have gait mobility problems and/or postural instability.

Start: January 2020

Pilot Intervention With Near Infrared Stimulation

The current study will test whether age-related cognitive and mood changes in older adults and those with Parkinson disease will be affected by near infrared (NIR) stimulation. The overall hypothesis, drawn from previous literature, is that exposure to NIR stimulation will have positive effects on brain health and will result in better cognitive and mood performance.

Start: June 2019

Study to Investigate the Effect of Hypoestes Rosea Powder in Parkinson's Disease

Parkinson's disease (PD) is a progressive neurological disease characterized by resting tremors, limb stiffness, impaired balance, and slow movement. There is no known cure for PD although levo-3,4 dihydroxyphenylalanine (L-DOPA) and dopamine agonists are effective for improving PD symptoms in the early years following diagnosis. Hypoestes rosea is an evergreen shrub which has anti-inflammatory, anticancer and antimalarial properties. Recent studies showed that the active pharmaceutical ingredient (API) of Hypoestes rosea, Hypoestoxide, was effective in modifying disease progression in a transgenic mouse model of PD. The aim of this study is to determine the efficacy of Hypoestoxide, as contained in Hypoestes rosea dry leaf powder, in improving motor symptoms in consenting PD patients. The study design is a double-blind, placebo-controlled cross-over trial involving 30 patients with mild to moderate disease (Stages 1-3 of Hoehn and Yahr scale over an 8-week period. The symptoms of the participants will be monitored using mobile phones with an established quantitative assessment tool, mPower2.0, which was previously developed for monitoring symptoms and disease progression in PD patients. In addition, the motor examination component of the International Movement Disorders Society scale will be administered and correlated with the finding on the mobile phone. The outcome measure is an improvement in the motor variables of the study participants with a 10% change from baseline over the 8 weeks of using Hypoestes.

Start: April 2021

Use of a Non-Invasive Brainstem Neuromodulation Device to Improve Neurovascular Status in Parkinson's Disease

This study is a single-site, double-blinded, randomized clinical trial designed to elucidate mechanism(s) of action for symptomatic benefits observed in Parkinson's disease (PD)

Start: June 2021

Lifestyle and Non-motor Symptom Management in Parkinson's Disease

Parkinson's Disease (PD) has generally been thought of as a movement disorder however other health-related symptoms, known as non-motor symptoms, are also very common. Non-motor symptoms can be very broad and present in numerous conditions, making identifying the symptoms of early-stage Parkinson's disease very difficult. Non-motor symptoms, including fatigue, and problems with sleep and mood, can happen decades before motor symptoms and have a greater impact on quality of life and psychological wellbeing. Despite this treatment options for non-motor symptoms are limited and therefore the development and testing of new treatments is a main priority. Due to the limited treatments options available, self-management of symptoms through positive lifestyle changes is a warranted area of research. The perspectives amongst patients, caregivers, and HCP's regarding lifestyle behavior change and its impact on fatigue and related non-motor symptoms has yet to be investigated in detail. This study includes two stages: telephone interviews and online consensus workshops. Patients with PD whom have experience of fatigue, partners/caregivers and Healthcare professionals will be able to participate in interviews only, workshops only or both. The interviews will investigate patients, partners/caregivers and Healthcare Professionals views and priorities of lifestyle factors in the management of non-motor symptoms in Parkinson's disease as well as identifying factors that influence lifestyle changes amongst PD patients. Stage 2 will involve small consensus workshops to generate ideas and feedback related to the design and content of the soon-to be developed lifestyle program. Results from both stages of this study will be used to help develop and design a lifestyle management program for fatigue and associated non-motor symptoms in Parkinson's Disease.

Start: May 2021

A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients

48 PD patients (age 35-75y; H&Y 1-3) testing positive in a stool PD-dysbiosis test will be randomized in a 2:1 ratio to receive either donor FMT or their own stool through intracaecal infusion. The main outcome measure will be the sum of MDS-UPDRS I-III at 6 months to cover motor and non-motor symptom changes. A wide array of secondary clinical outcome measures will be assessed longitudinally and a large array of measurements, biospecimens (stool, urine, blood, colonic biopsies), and imaging data will be collected for further analysis at baseline, 1, 6, and 12 months.

Start: November 2020

Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial

When Parkinson Disease is mild, it responds well to treatment with drugs (L-Dopa and dopamine antagonists). However, as the disease progresses, the effect of the drugs diminishes and lasts for a shorter time (wearing-off), which require physicians to progressively increase and/or break up the dosage of dopamine drugs, to control symptoms over the course of the entire day. Despite this, most patients present motor fluctuations after 10 years. These fluctuations consist of changes between what are known as Off periods, when the medication does not produce an effect and mobility is hindered, and On periods when patients can move smoothly, with the medication producing its best effect. The timeline of these motor fluctuations over the course of the day and also on different days is very valuable to precisely adjust the medication. Nevertheless, neurologists do not currently have detailed information on the timeline of the symptoms of their patients, which means that they have serious difficulties to obtain good results with the adjustment of medication. Currently, the neurologist's information on the time progression of the motor fluctuations is drawn from what the patient indicates in the office visit, or in the best case, from diaries that the patient fills out at home, periodically (e.g. every hour) noting the motor state (On or Off). Although the latter method is still the gold standard in research and in care, it has serious limitations, because patients often forget to record the information (especially when they are in Off), many do not recognize their motor states well, and few can maintain adherence to such a laborious system for more than a few days. The Parkinson Holter (STAT-ON ®) is a wearable device, which objectively measures and records the motor fluctuations of the patients. It does not require intervention by the patient, and can, therefore, be used in daily life, long term if necessary. However, the concept that detailed knowledge of motor fluctuations of patients will lead to better control of the disease, thanks to optimisation of the therapeutic regimen, is still a hypothesis. To demonstrate or refute this hypothesis, we are now conducting a clinical trial, with this medical device, to study the clinical effectiveness in patients with moderate Parkinson's disease and motor fluctuations. This trial will show whether using the Parkinson Holter is better than the clinical interview used in traditional clinical practice (primary objective), and whether it is not inferior to the On-Off diary recorded by the patients at home (exploratory objective)

Start: November 2019

Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism

The purpose of this study is to determine the efficacy of Droxidopa for the treatment of fatigue in patients with Parkinsonism by the Visual Analog Fatigue Scale (VAFS). This is a randomized, placebo-controlled, double-blind clinical trial for 3 months where half the subjects will receive placebo and the other half will receive Droxidopa. Following this will be a wash-out period of 7 days and then all subjects will receive Droxidopa for 3 months during the open-label phase.

Start: July 2021

The Relationship Between Neuropsychological Testing and MRI, PET and COBRE - Project 1: AIM 2 (GE-180)

The complex pathological cascades leading to both Alzheimer's disease (AD) and Parkinson's disease (PD) involve, at various points, inflammation. Since inflammation is a treatable symptom, understanding how and when it impacts the brain, and where specifically in the brain, would offer important guidance in the development of new treatments, sorely needed in both diseases. Microglia play an important anti-inflammatory role, and produce a substance, mitochondrial translocator protein (TSPO), whose presence can be used as a marker of regional inflammation. GE180 is a newly developed PET ligand which binds to TSPO and hence can be used in imaging studies to analyze regional inflammation in living patients. In prior studies it has shown regional specificity in multiple sclerosis and brain injury. In the current study, the investigators will be using GE180 to analyze regional and global inflammation in the brains of patients with AD and PD at two time points. The results of the current study will provide enriched understanding of inflammation in these conditions, and potentially provide preliminary data to inform design of future interventional trials.

Start: December 2018

PD-Ballet: Effectiveness and Implementation in Parkinson's Disease

Current literature consistently demonstrates beneficial motor effects of dance-based therapies in Parkinson's disease, along with improved quality of life. Little is known about the non-motor gains following such therapy. To date, no RTC has been conducted to investigate the benefits of ballet dancing in Parkinson's disease. The investigators aim to recruit 160 people with Parkinson's to either: participate in a 12-week ballet-based dancing intervention followed by a 'social Tea and Biscuit' session, or 12-week usual treatment monitoring and 'social Tea and Biscuit' sessions taking place after each intervention session. This study employs a randomised, controlled, single-blind, hybrid type 2 design with a hybrid implementation protocol to investigate both clinical efficacy of the programme and implementation aspects. The project's primary outcome measure is centered around non-motor symptoms of PD. Other measures include motor assessments, wearable sensors and quality of life assessments. Due to COVID-19 pandemic, the delivery of the sessions will be a hybrid model - virtual sessions will be the primary method, with some capacity for in-person delivery when possible and deemed safe.

Start: February 2021

Cartesia eXTend 3D Study

The purpose of the study is to document patient outcomes including effectiveness for Boston Scientific Corporation's Vercise Cartesia 16-contact Directional Lead(s) (X/HX) with Deep Brain Stimulation (DBS) systems for the treatment of Parkinson's Disease (PD).

Start: November 2020

Is Remote Physiotherapy Effective for People With Early Parkinson's (PEEP)

Parkinson's disease is a progressive neurodegenerative condition affecting 145,500 people in the UK. The condition impairs movement leading to gait and dexterity problems. Various types of exercise are beneficial for both motor and non-motor symptoms such as depression. The World Health Organisation's (WHO) recommendations on exercise include at least 150 minutes of moderate-intensity aerobic physical activity per week . People with Parkinson's may struggle to achieve this because of movement problems and fatigue. Physiotherapists may have a role in persuading people to exercise and supporting them in their activity goals. While studies show that Parkinson's patients with falls or gait freezing clearly benefit form physiotherapy, there is at present no robust evidence to demonstrate the impact of physiotherapy early in the course of the illness. PEEP seeks to explore the effectiveness of physiotherapy for early Parkinson's (ie within 4 years of diagnosis and before onset of falls). It comprises three distinct parts: A survey of people with Parkinson's exploring their experience and opinions with respect to physiotherapy for early Parkinson's A feasibility randomised controlled trial (fRCT) A qualitative process evaluation. The fRCT will aim to recruit and randomise 40 people withParkinson's who have been diagnosed in the last 4 years and have had no physiotherapy. These participants will undergo several assessments at baseline, 3 months and 6 months, and will also have 7 days' worth of activity monitoring done via physical diary and a commercially available activity tracker to determine levels of activity. Participants randomised to the intervention arm will also receive 5 physiotherapy sessions (1 for assessment and 4 for treatment) additional to standard NHS care. Staff and some participants involved in the fRCT will be included in a qualitative process evaluation to assess the acceptability and feasibility of the intervention and the research assessments.

Start: May 2021

Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS

The objective is to investigate whether AMPS (Automated Mechanical Peripheral Stimulation) is effective in reduction of FOG measured via the FOG-AC (Freezing Of Gait Assessment Course) in people with Parkinson Disease and STN-DBS (Subthalamic Nucleus Deep Brain Stimulation) in a randomized, double-blind, sham-controlled, cross-over trial

Start: March 2021

Effectiveness of Oculomotor Training in Parkinson's Disease

Parkinson's disease (PD) is a common neurodegenerative disorder which is characterized by both motor and non-motor symptoms and usually affects people aged 50 years or above. Many studies showed eye movement deficits and visual changes in patients with PD. Previous studies have also indicated that clinical eye movement training could enhance the functional performance of patients with various eye movement problems resulting from ocular and neurodegenerative diseases. In this study, we will investigate the effectiveness of eye movement training on dynamic vision and functional performance in PD patients with oculomotor deficits.

Start: September 2020

FoxBioNet: ECV (Extracellular Vesicle) 004

The goal of this study is to identify reliable markers of LRRK2 activity in human CSF.

Start: April 2021

Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease

The impact of urinary symptoms in Parkinson disease (PD) extends beyond worsened well-being. Urinary symptoms common in PD, especially incontinence and nocturia, are major risk factors for falls likely due to the combination of urinary urgency and impaired mobility (and falls are a leading cause of mortality in PD), for spouse/caregiver stress due to decreased mutuality in the relationship, and for institutionalization, largely due to increased disability. Additionally, most medications currently recommended for urinary symptoms in PD are anticholinergic and have the potential to worsen the progressive cognitive and autonomic burdens of the disease. Veterans with PD are also more likely to rely solely on VA for their health care than Veterans without PD. Thus, optimizing the care of urinary symptoms for Veterans with PD becomes imperative, particularly for VA. Using a non-inferiority design, this proposal seeks to demonstrate the comparative effectiveness of pelvic floor muscle exercise-based behavioral therapy versus drug therapy to treat urinary symptoms in PD.

Start: March 2018

Evaluation of the Benefit Provided by Sessions of Sophrology on the Per Operative Management of Parkinsonian Patients Planned for a Deep Brain Stimulation Surgery.

Deep brain stimulation surgery, which consists of intracerebral implantation of electrodes, is considered one of the most effective techniques for controlling the motor fluctuations of Parkinson's disease. The particularity of this surgery is the necessity of the awakening of the patient for the correct positioning of the electrodes, it is therefore a difficult test for the patient. Medical sophrology is an ideal strategy to optimize the comfort of the patient during the operation thanks to its anxiolytic and analgesic virtues while guaranteeing the maintenance of a good patient vigilance favoring the cooperation with the operating room team. Indeed, sophrology is a body-mediated set of techniques, at the crossroads between hypnosis and yoga, which makes it possible to find a balance between emotions, thoughts and behaviors. It has already been applied in other fields such as oncology, pain management, preparation for childbirth, and for 5 years at the CHU of Rennes for preparation for the intervention of deep brain stimulation.

Start: December 2017

Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.

Start: January 2017

Validation of the Neuropsychiatric Fluctuations Scale (EFN-VALID))

Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD. The main goal of this project is to validate the NF-scale in french language in a multicenter approach.

Start: September 2020

Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation

This study evaluates the effect of transcranial direct current stimulation (tDCS) on non-motor symptoms of Parkinson's disease, including depression and cognitive symptoms. Participants are randomized to receive active or sham tDCS for 30 minutes over 10 treatment sessions.

Start: February 2016