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546 active trials for Parkinson Disease

Brain Sensing in Neurological and Psychiatric Disorders

High-frequency deep brain stimulation (DBS) is an effective treatment strategy for a variety of movement disorders including Parkinson's disease, dystonia and tremor1-5, as well as for other neurological and psychiatric disorders e.g. obsessive compulsive disorder, depression, cluster headache, Tourette syndrome, epilepsy and eating disorders6-11. It is currently applied in a continuous fashion, using parameters set by the treating clinician. This approach is non-physiological, as it applies a constant, unchanging therapy to a dysfunctional neuronal system that would normally fluctuate markedly on a moment-by moment basis, depending on external stressors, cognitive load, physical activity and the timing of medication administration. Fluctuations in physical symptoms reflect fluctuations in brain activity. Tracking and responding in real-time to these would allow personalised approaches to DBS through stimulating at appropriate intensities and only when necessary, thereby improving therapeutic efficacy, preserving battery life and potentially limiting side-effects12. Critical to the development of such adaptive/closed-loop DBS technologies is the identification of robust signals on which to base the delivery of variable high-frequency deep brain stimulation. Local field potentials (LFPs), which are recordable through standard DBS electrodes, represent synchronous neuronal discharges within the basal ganglia. Different LFP signatures have been identified in different disorders, as well as in different clinical states within individual disorders. For example, low frequency LFPs in the Alpha/Theta ranges (4-12Hz) are frequently encountered in patients with Dystonia13,14, while both beta (12-30Hz) gamma (60-90Hz) band frequencies may be seen in Parkinson's disease, when the patient is OFF and dyskinetic, respectively15,16. Equally, suppression of these abnormal basal ganglia signals through medication administration or high-frequency DBS correlates with clinical improvement. As such, they represent attractive electrophysiologic biomarkers on which to base adaptive DBS approaches. Until recently, neurophysiological assessments were purely a research tool, as they could only be recorded either intra-operatively or for a short period of time post-operatively using externalised DBS electrodes. However, advances in DBS technology now allow real-time LFP recordings to be simply and seamlessly obtained from fully implanted DBS systems e.g. Medtronic Percept PC. In this study, we will evaluate a cohort of patients with movement disorders and other disorders of basal ganglia circuitry who have implanted DBS systems. Recordings of LFPs and/or non-invasive data such as EEG, limb muscle activation and movement (surface EMG and motion tracking) under various conditions (e.g. voluntary movement, ON/OFF medications, ON/OFF stimulation) will allow us to evaluate their utility as markers of underlying disease phenotype and severity and to assess their potential for use as electrophysiological biomarkers in adaptive DBS approaches. These evaluations in patients with DBS systems with and without LFP-sensing capabilities will take place during a single or multi-day evaluation (depending on patient preference and researcher availability). This study will advance not only the understanding of subcortical physiology in various disorders, but will also provide information about how neurophysiological and behavioural biomarkers can be used to inform personalised, precision closed-loop DBS approaches.

Start: July 2021

Role and Mechanism of Probiotics in Improving Motor Symptoms in Mild to Moderate Parkinson's Disease

This study is a multicenter randomized double-blind placebo-controlled study. The research content is 1. The improvement effect of Bifidobacterium triple viable capsules?BIFICO? on motor symptoms and constipation and sleep in mild to moderate Parkinson's disease and the safety of the study; 2. the mechanism of the improvement effect of intestinal microecological changes on motor and constipation symptoms in mild to moderate Parkinson's disease.

Start: May 2021

Exergames in In-patient Rehabilitation

This pilot trial aims to evaluate the feasibility and effectiveness of a technology-based intervention for cognitive-motor training in rehabilitation clinics with geriatric, neurological and cardiac patients. The primary objective of this pilot study is to evaluate the feasibility of exergame-based cognitive-motor training in in-patient rehabilitation settings. The secondary objective of this pilot trial is to evaluate the effectiveness of an expanded rehabilitation treatment (combining exergame training with conventional care) on physical and cognitive functioning in different patient groups.

Start: January 2021

Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis

Parkinson's disease (PD) is the second most common neurodegenerative disease. Multiple system atrophy (MSA) is a relentlessly progressing rare neurodegenerative disease of unknown etiology. In early stages of the disease, PD and MSA symptoms are very similar, particularly MSA-P where Parkinsonism predominates. The differential diagnosis between MSA-P and PD can be very challenging in early disease stages, while early diagnostic certitude is important for the patient because of the diverging prognosis. Voice disorders are a common early symptom in both diseases and of different origin. The ambition and the originality of this project are to develop a digital voice-based tool for objective discrimination between PD and MSA-P.

Start: June 2018

In-Home Care for Patients With Parkinson's Disease

Advanced Parkinson's Disease is a debilitating, costly, and understudied condition. Improving access to comprehensive, specialized, in-home patient care and caregiver support offers the potential to minimize the downward spiral of morbidity and preventable healthcare utilization. The aim of this study is to test whether and to what degree an interdisciplinary home visit program, with and without peer mentoring for caregivers, will improve patient- and caregiver-reported outcomes and reduce healthcare costs when compared with usual care in advanced Parkinson's Disease.

Start: May 2018

Randomized Placebo Controlled Trial Evaluating the Efficacy of Pimavanserin, a Selective Serotonin 5-HydroxyTryptamine-2A (5HT2A) Inverse Agonist, to Treat Impulse Control Disorders in Parkinson's Disease.

There is no consensus on the treatment of Impulse Control Disorder (ICD) in Parkinson Disease (PD) though it is recommended to reduce the dosage of dopamine agonists (DA). Reduction of DA frequently leads to a worsening of motor signs (parkinsonism or dyskinesias due to the concomitant increase of levodopa doses) and non-motor signs with the appearance of a DA withdrawal syndrome (DAWS). Chronic stimulation of the sub-thalamic nuclei may reduce ICD but is restricted to a minority of patients and cases of new-onset ICD symptoms post stimulation have been reported. The benefit of amantadine in pathological gambling is controversial and the efficacy of clozapine has been reported in a few cases but with serious safety limitations. Very recently, naltrexone did not significantly improve ICD. Thus, an efficacious and safe treatment of ICD in PD remains an unmet need for clinical practice. Recently, it has been reported that pimavanserin, a selective serotonin 5-HT2A inverse agonist with a satisfactory safety profile without motor side effects, was efficient in improving psychosis, insomnia and day-time sleep in PD. Pimavanserin, marketed under the tradename NUPLAZID® was approved in 2016 by the U.S. Food and Drug Administration (FDA) for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. The link between serotonin and ICD has been well established, since the enhancement of 5HT2A receptors stimulation is associated to ICD, since serotonin modulates mesolimbic dopaminergic reward system transmission and given that serotonin neurotransmission is increased during chronic intake of dopamine agonist such as pramipexole which is well-known to induce ICD in PD patients. Thus, there is a large body of evidence suggesting that the decrease of the 5HT2A activity could be efficient in reducing ICD in PD. This further supports the concept of testing the efficacy of pimavanserin (a selective 5HT2A inverse agonist) for treating ICD in PD. Our aim is to conduct a study evaluating the efficacy and safety of pimavanserin on ICD in PD. This clinical trial is conducted with the support of the French NS-Park/FCRIN (French Clinical Research Infrastructure Network) network.

Start: October 2020

Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease

The present study is a proof-of-concept clinical trial to test the efficacy of low doses of a repurposed anti-epileptic drug (levetiracetam) in treating memory problems in Parkinson's disease (PD). Neuroimaging techniques will be used to determine the effect of the drug on specific brain regions (hippocampal subfields). Finally, baseline brain activity of PD patients with memory problems will be compared to PD patients without memory problems and healthy older adults to determine if activity in specific brain regions (hippocampal subfields) can be used to predict memory problems in PD. This information will be useful for future clinical trials to target drugs to these brain regions.

Start: February 2021

Role of Sleep on Motor Learning in Parkinson's Disease and Healthy Older Adults

People with Parkinson's disease (pwPD) often present difficulty consolidating newly learned skills into long-term memory. Sleep facilitates motor memory consolidation in healthy adults, especially in combination with targeted memory reactivation (TMR). TMR works by adding associated sounds during learning that are replayed during sleep and thus reinforce the recently formed neural connections. Importantly, recent work suggested that consolidation during sleep may be preserved in pwPD, but robust findings are lacking and have not involved TMR. The objective of the present study is to address this imperative question by investigating the effect of napping on motor memory consolidation by experimentally manipulating exposure to sleep and TMR for the first time. Concretely, the investigators will first compare the effect of a 2-hour nap to that of a wake control period in pwPD and healthy age-matched controls. A validated motor sequence learning task will be used to test for behavioral markers of motor learning and polysomnography with electroencephalography (EEG) will be conducted to study the neural correlates of sleep-related motor learning effects. In a second experiment, the investigators will then test the effects of adding TMR during post-learning sleep, by comparing performance on two motor sequences of which only one is reactivated during post-learning napping using auditory TMR.

Start: November 2019

A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease

Objective of this study is to investigate the safety, pharmacokinetics and efficacy of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.

Start: May 2021

Synaptic Density and Progression of Parkinson's Disease.

AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with PD. DESIGN: We will include 30 PD patients and 20 healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FE-PE2I PET-MR at baseline and after 2 years.

Start: October 2018

Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study

The PASS-PD study is set out to screen individuals from the general population with an increased risk for the development of Parkinson's Disease (PD) and to investigate this highly enriched cohort longitudinally for five year. A special focus is placed on implementation of ethical standards for early risk disclosure in PD.

Start: June 2021

Education for Adapted Physical Activity in Parkinson's Disease

Parkinson's disease is a progressive disorders characterized by motor and non-motor symptoms. Actual medical treatments are symptomatic and have little efficacy on late stage axial motor symptoms. Non-pharmacological approaches are therefore essential from the disease onset. Beside physiotherapy, to practice a regular adapted physical activity is crucial. To implement such a practice in everyday life implies to change habits. Patient Education programs are useful tools to help changing behaviors. The study evaluate the effect of a program aiming to promote adapted physical activity in early stage Parkinson's disease by comparing patients receiving the program and patients on a waiting list. The hypothesis that the program will increase the one-week mean daily moderate to intense physical activity as measured with an actimeter.

Start: March 2021

DBS and Respiration

Patients referred to neurosurgery routinely and safely undergo deep brain stimulation (DBS) for treatment of neurological conditions, most commonly Parkinson's disease. The investigators have observed that respiratory problems (breathlessness) sometimes occur subsequent to DBS of the subthalamic nucleus (STN). This study aims to determine whether this is indeed a consequence of STN stimulation. Secondary objectives include identification of the respiratory physiological mediators of any interoceptive neuromodulation observed, changes in daily physical activity and MRI structural connectivity analysis.

Start: April 2021

Sound and Vision: A Collaboration Between Service-users, Artists and the Public to Explore the Lived Experience of Hallucinations

Sound and Vision: A collaboration between service-users, artists and the public to explore the lived experience of hallucinations

Start: December 2020

A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology

The purpose of study is to demonstrate the pharmacodynamic (PD) effects of E2027 on cerebrospinal fluid (CSF) cyclic guanosine monophosphate (cGMP) in participants with DLB and PDD with and without amyloid copathology after 9 weeks of treatment.

Start: February 2021

Decreased Empathy and Emotion Recognition in Patients With Neurodegenerative Disease

This study evaluates an educational brochure tailored to caregivers of people with Alzheimer's disease, Parkinson's disease dementia, Lewy body disease, frontotemporal dementia, and vascular disease dementia. The goal of the brochure is educating caregivers about the decreased ability to detect emotion and decreased empathy that can be seen in dementia, increasing caregiver competence in providing care, and teaching caregivers ways to manage over time that lessens burden and improves quality of life.

Start: July 2019

Clinical and Physiological Studies of Tremor Syndromes

Background: Researchers have some data on how the brain controls movement and why some people have tremor. But the causes of tremor are not fully known. Researchers want to study people with tremor to learn about changes in the brain and possible causes of tremor. Objective: To better understand how the brain controls movement, learn more about tremor, and train movement disorder specialists. Eligibility: People ages 18 and older with a diagnosed tremor syndrome Healthy volunteers ages 18 and older Design: Participants will be screened with: Medical history Physical exam Urine tests Clinical rating scales Health questions They may have electromyography (EMG) or accelerometry. Sensors or electrodes taped to the skin measure movement. Participation lasts up to 1 year. Some participants will have a visit to examine their tremor more. They may have rating scales, EMG, and drawing and writing tests. Participants will be in 1 or more substudies. These will require up to 7 visits. Visits could include the following: EMG with accelerometry Small electrodes taped on the body give small electric shocks that stimulate nerves. MRI: Participants lie on a table that slides into a cylinder that takes pictures of the body while they do simple tasks. Small electrodes on the scalp record brain waves. A cone with detectors on the head measures brain activity while participants do tasks. A wire coil held on the scalp gives an electrical current that affects brain activity. Tests for thinking, memory, smell, hearing, or vision Electrodes on the head give a weak electrical current that affects brain activity. Photographs or videos of movement Participant data may be shared with other researchers.

Start: May 2017

Brain Activity During Gait in Parkinson's

Lay Summary: Walking problems, such as slow and short steps, are very common in Parkinson's disease and lead to increased falls risk, as well as reduced mobility and quality of life. Walking issues are difficult to treat as medication interventions do not restore walking ability in people with Parkinson's, therefore physiotherapy approaches are used to help improve walking. Various physiotherapy strategies have been used, such as internal (thinking about bigger steps) or external prompts. External prompts include auditory (a metronome beat to step in time to), visual (lines to step over on the floor) and tactile (metronome-like vibration to step with) prompts that are very commonly used to improve walking in Parkinson's. However, the reason why walking improves in people with Parkinson's with these physiotherapy strategies is unknown, which has led to not all patients benefiting and only short-term walking improvements being seen. The main issues are that it is unclear if these various internal or external prompt strategies are effective with the progression of Parkinson's disease, and it is unknown which type of strategy is most effective at different disease stages or with more severe walking impairment, such as freezing (the inability to progress walking for short periods despite wanting to do so). Being able to use specific brain regions to pay attention to different internal or external prompts has been suggested to be the reason why people with Parkinson's can overcome their walking problems, but this has not been tested. Therefore, this study will use state-of-the-art digital technology to measure walking and brain activity changes with different internal and external prompts. The investigators think that the walking improvement with different prompt strategies relies on the ability to activate specific brain regions, and that brain region activity in response to internal or external prompts will change at different stages of Parkinson's disease. Ultimately, understanding the reasons why people benefit from these physiotherapy strategies and who benefits most from specific strategies will enable clinicians to provide more timely and efficient treatment for people with Parkinson's, and to develop more effective strategies to further improve walking.

Start: October 2020

Facilitating Motor Skill Learning in Parkinson's Disease III

The study is designed to assess the effects of cardiovascular (aerobic) exercise on motor skill learning in Parkinson patients. Specifically, the investigators examine whether moderate-intense aerobic exercise, performed immediately following motor skill practice over the course of a six week intervention period, facilitates motor memory consolidation. In this experimental trial, participants will be randomly allocated to either an intervention group (motor skill practice + aerobic exercise) or control group (motor skill practice + seated rest).

Start: July 2021

Effect of Probiotic on Constipation in Patients With Parkinson's Disease

The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis ®duo) effect on constipation and on neuropsychological performance

Start: May 2019