Clinical Research Directory

A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease

In Parkinson's disease (PD), there is inflammation in the brain, the gut and the blood, which is thought to contribute to the development and progression of the disease. The Nod-like receptor (NLR) family pyrin domain containing 3 (NLRP3) inflammasome is a complex of proteins which plays a critical role in mediating inflammation, and there is growing evidence from laboratory research that the inflammasome plays a role in Parkinson's disease. Dapansutrile is a new drug which has a highly specific effect on the NLRP3 inflammasome. In animal models, dapansutrile can protect against inflammation in the brain and prevent loss of dopamine cells. Initial 'in human' studies have indicated that this drug can effectively reduce inflammation without causing significant side effects. The goal of this clinical trial is to test whether dapansutrile might be a useful treatment for Parkinson's disease. The main questions it aims to answer are: 1. is dapansutrile safe and well-tolerated in people with Parkinson's? 2. does dapansutrile reduce inflammation in the brain, cerebrospinal fluid (CSF) and blood? Changes in clinical symptoms will also be measured over the course of the trial. Researchers will compare dapansutrile to a placebo (a look-alike substance that contains no drug) to see whether it is safe and what effects it has on inflammation and on clinical symptoms. Participants will be asked to take dapansutrile or a placebo every day for 6 months. Following this, all participants will be given the option to take dapansutrile every day for an additional 6 months. Participants will visit the study centre regularly throughout the trial for check-ups and blood tests. They will have a brain scan before starting treatment and again after 5-6 months. They will also be asked to have a lumbar puncture at the beginning of the trial, after 6 months of treatment and after 12 months of treatment.

Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices

The goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases. This study aims to evaluate the effectiveness of traditional physical activities combined with innovative interventions such as cryotherapy, ultrasound therapy, laser therapy, transcranial magnetic stimulation (TMS), and transcranial direct current stimulation (tDCS). It will also assess the impact of proprioceptive stimuli provided by either the immersive virtual reality (CAREN), or visuo-cognitive-motor enhancement (S.V.T.A.), and music therapy. The main questions it aims to answer are: How do these interventions affect motor activities and their functional recovery? What are the temporal and spatial changes in activation sequences related to motor learning and maintenance? When there is a comparison group: Researchers will compare outcomes between different intervention arms (e.g., physical activity with advanced devices vs. traditional methods) to find out if the advanced interventions result in better motor control and functional recovery. Participants will: * Undergo various rehabilitation protocols including physical activity and advanced interventions. * Be assessed using different tool, such as fMRI, dtMRI, and NIRS to study in vivo neuroimaging and assess changes in brain function and connectivity.

Neuroplasticity in Parkinson's Disease

The purpose of this project is to increase our understanding of the early state and temporal evolution of neuroplastic changes in the cortex and subthalamic nucleus (STN) of people with PD, and the relationship of these changes to the emergence and expression of PD motor and non-motor signs. Neurophysiological biomarkers derived from this work may be important for the early detection and prediction of progression of disease. They can also provide the means to assess the efficacy of interventions designed to prevent or slow disease progression.

Expanded Access to Tavapadon

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to tavapadon prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Exploratory Study About the Implementation of Technology in the Rehabilitation

This qualitative study aims to identify the needs and recommendations of both patients and healthcare professionals in terms of rehabilitation technology, more specific three pre-defined user scenarios. These scenario were developed based on brainstorm sessions with healthcare professionals from the rehabilitation ward of UZ Brussel and AZ Sint-Maria Halle. The purpose of this study is to create an overview of recommendations that will be used to develop the smart devices in a later stage of the SAIRE project.

The Relationship Between Upper Extremity Function and Balance and Functional Mobility in Parkinson's Disease

Parkinson's Disease (PD) is the second most common neurodegenerative disease, affecting 2-3% of the population aged 65 and over, characterized by the loss of dopaminergic neurons. The basal ganglia play a significant role in the pathogenesis of PD. The lesions of the basal ganglia impair the ability of patients to perform complex, goal-oriented, and skill-requiring movements. Consequently, motor symptoms such as bradykinesia, rigidity, hypokinesia, and tremor, which are progressively worse, are added to the clinical picture of the disease. These symptoms, which cause movement and activity limitations in individuals with PD, also affect upper extremity functions, balance, and functional mobility. Impairment of upper extremity functions, commonly seen from the early stages of the disease, can affect many basic activities of daily living, including buttoning clothes, tying shoelaces, sewing, writing, eating, and using various modern devices. Balance and mobility disorders are among the most debilitating features of the disease, as they lead to the deterioration of physical functions in PD. Balance and mobility issues in PD are identified as key determinants of the increasing fear of falling and the resulting decline in quality of life. Various factors such as rigidity, bradykinesia, impaired postural adjustments, and decreased sensory integration contribute to the negative impact on balance and mobility in individuals with PD. Proper balance and mobility performance are achieved through synergistic control during both dynamic and static postures between proximal body segments such as the trunk, spine, and pelvis. This contributes to the mobility of distal segments and the functionality of the upper extremities. Additionally, the contribution of upper extremity functions to balance and mobility has been demonstrated in healthy populations. Current literature also reveals that treatment programs targeting the upper extremities can improve mobility and balance, especially in neurological patient populations. In conclusion, balance and mobility disorders in Parkinson's disease can reduce proximal stability and affect hand dexterity. This study aims to examine the relationship between hand dexterity, balance, and functional mobility in individuals with PD.

A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease

The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway.

Estimates of the Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease

This study is double-blinded placebo controlled followed by an open-label extension placebo-to-active switch to estimate the efficacy of Talineuren. The investigational Medicinal Product (IMP) is administrated 48 times intravenously as an add-on therapy to the standard of care Parkinson medication. Talineuren is a liposomal formulation containing GM1 (monosialotetrahexosylganglioside) as the pharmacological active substance. The results of this pilot study are essential for the sample size calculation of a subsequent larger phase II/III trial.

Cognitive-Motor Training for Gait Adaptability in Parkinson Disease

Cognitive-motor training combines thinking tasks with physical movements, encouraging participants to choose appropriate actions and adjust their movements according to different task demands. Training that involves stopping or changing a movement may help people with Parkinson's disease respond to changing situations. These abilities may also support walking in challenging environments, such as stepping over obstacles. However, the effects of this type of training on cognitive function, walking performance, and brain activity remain unclear. Therefore, this study aims to compare the effects of cognitive-motor co-dependent training with conventional exercise training on these outcomes in people with Parkinson's disease.

Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease

Parkinson's disease (PD) is one of the most common neurodegenerative diseases characterized by the progressive loss of dopaminergic (DA) neurons in the substantia nigra compacta (SNc) and aggregation of Lewy bodies in neurons. Although aging, oxidative damage and neuroinflammation have been recognized to play crucial roles in the pathogenesis of PD, the precise etiology remains obscure. Emerging evidence suggests PD is a systemic metabolic disease, and metabolic abnormality correlates with functional alternations in PD

Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital

This retrospective observational study aims to evaluate the efficacy and toxicity of advanced radiotherapy (ART) techniques, including intensity-modulated radiotherapy (IMRT), image-guided radiotherapy (IGRT), and stereotactic radiotherapy (SRT), used at IRCCS Ospedale San Raffaele over the past 25 years and 5 months. The study includes treatments delivered using conventional fractionation, moderate hypofractionation, and ultra-hypofractionation. The primary endpoint is local control, defined as biochemical control in patients with prostate cancer.

Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease

This cross-over pilot study aims to study the acceptability of two methods of non-invasive brain stimulation for the treatment of Parkinson's disease mild cognitive impairment (PD-MCI) - repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) targeted at the left dorsolateral prefrontal cortex (DLPFC). Twenty participants will undergo both interventions in a cross-over design. They sequentially undergo four consecutive phases (4 weeks each), 1) no-intervention baseline, 2) rTMS ór tDCS, 3) no-intervention, 4) second intervention. The primary outcome measure will be acceptability of the interventions, and secondary outcomes include feasibility, cognitive function, neuropsychiatric symptoms, motor function. We will use MRI to explore personalized targeting.

PD Frontline (Part of RAPSODI GD) Remote Assessment of People With Parkinson's

PD Frontline (part of RAPSODI GD) is an online study observational study for People with Parkinson's. The aims are to better understand the genetic nature of Parkinson's and to connect participants to clinical trials and studies, particularly those with a genetic focus. To do this, participants are offered genetic sequencing for two common genetic risk factors for Parkinson's Disease, the GBA1 and LRRK2 gene, with an at-home sample collection kit. Return postage is free.

Studies of Frontal Lobe Brain Functioning in Schizophrenia

The purpose of this study is to use brain imaging technology to investigate the role of the frontal lobe of the brain in the thinking of individuals with schizophrenia and other neuropsychiatric disorders and healthy volunteers. Participants in this study will undergo a positron emission tomography (PET) scan of the brain while performing neuropsychological tests. Some of the tests involve cognitive operations that depend upon the frontal cortex. Interactions between frontal lobe activation, cognitive behavior, and neuropharmacology will be assessed by measuring regional cerebral blood flow (rCBF) during treatment with drugs that may affect frontal lobe physiology.

Genetic Studies of Lysosomal Storage Disorders

The purpose of this study is to identify genetic, biochemical, and clinical factors that are associated with disease severity in people with Gaucher disease and other lysosomal storage disorders. There is a vast spectrum of clinical manifestations in people with Gaucher disease as well as other lysosomal storage disorders. This study will evaluate patients with lysosomal disorders on an outpatient or inpatient basis in order to better characterize the clinical, genetic, and pathophysiological features of these disorders. Participants will be re-evaluated on an annual basis.

Respiratory Functions in Parkinson's Disease

The aim is to examine respiratory functions, inspiratory muscle strength, respiratory function, physical fitness and aerobic capacity in Parkinson's disease patients. Individuals between the ages of 50-80 who have been diagnosed with Parkinson's disease by a neurologist and healthy individuals with similar demographic characteristics will be included in the study as a control group. In addition, patients will be divided into three groups as above and below 2.5 and healthy controls according to the Modified Hoehn and Yahr Scale. Demographic information of the individuals will be recorded and clinical evaluations will be made. The staging of Parkinson's patients will be done with the Modified Hoehn and Yahr Scale, and the severity of the disease will be done with the Unified Parkinson's Disease Rating Scale. The inspiratory muscle strength of the individuals will be evaluated with the PowerBreath K5, respiratory functions with the Pulmonary Function Test device, and physical fitness and aerobic capacity with the Senior Fitness Test.

A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations

This is a Phase 2 study in people with Parkinson's disease who experience motor fluctuations while taking levodopa. The study will evaluate how effective two different doses of the study drug AP-472 are when added to levodopa treatment, compared with a placebo. The study will last about 14 weeks. Participants will be randomly assigned to receive one of the two doses of AP-472 or a placebo. Neither the participants nor the study staff will know which treatment is given. The study includes a screening period, a 4-week period during which Parkinson's medications must remain stable, and a 12-week treatment period. During the treatment period, limited adjustments to levodopa are allowed if needed.

Tapping Test and the Archimedean Spiral for the Differential Diagnosis of Tremor. Machine Learning Approach

In clinical practice, it is sometimes difficult to establish whether a patient's tremor is due to Parkinson's disease or essential tremor. The distinction is crucial as the health implications differ significantly between the two conditions. Therefore, the present study aims to develop a diagnostic method based on machine learning techniques to help differentiate whether a patient's tremor is due to one condition or the other. To achieve this, 110 patients with tremor, correctly diagnosed with either Parkinson's disease or essential tremor, will participate. They will undergo two diagnostic tests (tapping test and Archimedean spiral) to capture data that can be processed using machine learning techniques.

Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease

The purpose of this study is to learn about different treatments for overactive bladder symptoms in Parkinson's Disease. The investigators want to find out if people who do not respond to one treatment (either behavioral or drug treatment) will respond to combined treatment. The investigators also want to find out what factors influence whether someone responds to the treatments.

Genetics and Aerobic Exercise to Slow Parkinson's Disease Trial

The proposed multi-site, Genetics and Aerobic Exercise to Slow PD (GEARS) Trial will, for the first time, determine the interplay between genetics and exercise in altering PD progression. In sum, 200 PD patients will be recruited from the Cleveland and Salt Lake City metro areas to participate in the Pedaling for Parkinson's (PFP) community-based exercise program. Participants will exercise at community-based sites 3x/week for 12 months. All participants will undergo genotyping using an array that includes the genome backbone and common risk variants associated to increase risk for multiple neurological disorders including PD.

Repurposing Lithium for Parkinson's Disease: a RCT

This study will examine the effects of lithium 20mg/day compared to placebo on MRI and blood-based biomarkers among 20 early-stage Parkinson's disease patients.

Lithium for Parkinson's: an Extension Trial

This study will examine the effects of 24 weeks of lithium therapy achieving serum lithium levels of 0.25-0.50mmol/L on MRI and blood-based biomarkers in Parkinson's disease patients who have completed one of our current 24-week lithium clinical trials.

Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease

The purpose of this study is to learn how brain signals are related to freezing of gait (FOG) and balance problems in Parkinson's disease (PD) and to study how different deep brain stimulation (DBS) settings may affect these symptoms.

Investigation of the Benefits of Electrical Non-invasive Stimulation on Cognitive Symptoms in Parkinson's Disease

Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's disease. It is mostly characterized by the presence of motor difficulties. However, it can also be accompanied by cognitive disorders which have an equally significant impact on the quality of life of patients and which are not relieved by any treatment. Among the functions affected by Parkinson's disease, inhibition is an essential process for adapting our behaviors in daily life. Inhibition allows us to stop an action that is no longer required or appropriate to the situation in which we find ourselves in. For example, it comes into play when we have to stop at a "stop" sign while driving. Recent studies suggest that it could be possible to improve the functioning of these processes by using non-invasive brain stimulation tools. Transcranial alternating current electrical stimulation has thus showed promising results in improving functions such as working memory. This technique is completely painless and non-invasive and consists in applying an electric current of very low intensity (barely perceptible) at the level of the scalp, using electrodes. The investigators are conducting a study to test whether transcranial alternating current electrical stimulation could improve the functioning of the inhibition process which is altered in patients. For this, the investigators will measure this process using a task performed on a computer (the Stop Signal Reaction Time Task), as well as brain activity using a method called "electroencephalography", before and after stimulation. For this study, the investigators will include 50 patients and 40 healthy participants to investigate the effect of the stimulation on inhibition.