Clinical Research Directory

A Study of Buntanetap in Participants With PD

This study will examine the long-term safety of buntanetap in participants with PD. This will be a 36-month open-label safety study. This study will be conducted with two cohorts. Cohort 1 will enroll via invitation only for PD participants who have previously participated in buntanetap clinical trials. Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment. Qualified participants will receive buntanetap 30mg QD after a screening period of up to 42 days.

A Phase 2 Study to Assess the Effects of SUL-238 on High Energy Phosphates With ³¹P-MRS in Patients With Early, Untreated Parkinson's Disease

The main goal of the study is to investigate how well the new drug SUL-238 works in Parkinson's Disease (PD). This is done by means of an MRS scan. An MRS scan is similar to a regular MRI scan. It will also learn about the safety of new drug SUL-238. The main questions it aims to answer are: * Does new drug SUL-238 improve the mitochondrial function in patients with Parkinson's Disease (PD)? * What medical problems do participants have when taking new drug SUL-238? Researchers will compare new drug SUL-238 to a placebo (a look-alike substance that contains no drug) to see if SUL-238 works to improve mitochondrial function in patients with PD. Participants will: * Take new drug SUL-238 or a placebo every day for 28 days * Visit the clinic once every 2 weeks for checkups and tests during the treatment period and finally 28 days after the last dose of SUL-238 * Keep a diary of their symptoms and the number of times they use oral new drug SUL-238

Electrophysiology-based DBS Programming for PD

Deep brain stimulation (DBS) effectively alleviates motor symptoms in Parkinson's disease (PD). However, current programming is manual and time-consuming. This study will evaluate physiology-based programming using local field potentials (LFPs) to identify optimal stimulation parameters. Specifically, DBS contact selection based on beta power and a broad-band approach will be compared with conventional clinician-based programming.

Effects of the Stimulation Site of tsMS With TMS on Functional Mobility in Individuals With Parkinson's Disease

This randomized clinical trial aims to compare the effects of two different trans-spinal magnetic stimulation (tsMS) application sites, cervical versus thoracic, when combined with repetitive transcranial magnetic stimulation (rTMS), on functional mobility in individuals with Parkinson's disease (PD). Participants diagnosed with PD will be randomized into two intervention groups (rTMS + cervical tsMS or rTMS + thoracic tsMS) and will undergo 10 treatment sessions. Outcomes will include functional mobility, gait speed, motor function, freeing of gait, balance, quality of life, global perceived improvement and adverse events. The study is expected to identify the most effective tsMS application site to enhance mobility and motor outcomes in PD, contributing to the optimization and standardization of tsMS protocols as an adjunct therapy.

Effects Of Strategy Training And PNF On Balance, Gait, And Independence In Parkinson's Disease

This randomized controlled trial aims to compare the effects of Strategy Training and Proprioceptive Neuromuscular Facilitation (PNF) on balance, gait, and functional independence in patients with Parkinson's disease. Parkinson's disease leads to impaired motor function, reduced balance, and decreased independence. Physiotherapy interventions such as strategy-based training and PNF may help improve mobility and functional performance. Participants will be randomly assigned to two groups: one receiving Strategy Training and the other receiving PNF intervention. Outcome measures including balance tests, gait assessment, and functional independence scales will be evaluated before and after treatment. The study aims to determine which intervention is more effective in improving functional outcomes in Parkinson's disease patients.

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

This is a first-in-human (FIH) study of orally administered VT-5006 (also known as AX-5006) in healthy adult volunteers (HVs) and adult participants with Parkinson's disease (PD). The goal of this clinical trial is to learn if VT-5006 is safe and tolerable in healthy volunteers and in participants with PD. It has three Parts (A, B, and C). Part A: Healthy volunteers aged 18-54 will attend a screening visit, take a single dose of VT-5006 or matching placebo after an overnight fast, stay in the clinic for three nights, and complete a follow-up visit. One group of participants in Part A will be asked to return to the clinic after approximately two weeks, take a single dose of VT-5006 or matching placebo after consuming a high-fat meal and stay in the clinic for another three nights. Part B: Healthy volunteers aged 18-54 will attend a screening visit, take one dose of VT-5006 or matching placebo each day for seven days after fasting overnight, stay in the clinic for 10 nights, and complete a follow up visit. Part C: Participants with PD aged 40-80 will attend a screening visit, take one dose of VT-5006 (high dose), VT-5006 (low dose), or matching placebo each day for 28 days, complete two overnight stays in the clinic, attend three clinic visits, one phone call and a follow up visit.

LFP-based Parameter Prediction in DBS for Parkinson's Disease

The goal of this observational study is to assess whether deep brain stimulation (DBS) contact selection in Parkinson's disease could be informed by subcortical local field potential (LFP) recordings. The main question it aims to answer is: Aligns stimulation contact selection based on subcortical LFP recordings with clinically optimized contact selection? Participants will undergo LFP recordings that are part of standard clinical care during their routine hospital visits.

Understanding Alpha-Synuclein Spread in Parkinson's Disease Through Blood Biomarkers and Neuroimaging

The project aims to investigate how abnormal accumulation of alpha synuclein and its interaction with tau influence brain function across the Parkinson's disease (PD) spectrum, with particular focus on individuals carrying GBA1 mutations. This interventional, monocentric, cross sectional study includes patients with PD, individuals with idiopathic REM sleep behavior disorder, and participants without PD. All enrolled subjects will undergo clinical and neuropsychological assessments, blood based biomarker analyses related to neurodegeneration, synaptic and mitochondrial function, and multimodal brain MRI to evaluate brain structure, white matter integrity, and functional connectivity. The study aims to: * characterize the relationship between alpha synuclein/tau pathology and synaptic mitochondrial dysfunction; * identify biomarker and connectivity signatures across disease stages and genetic backgrounds; * integrate preclinical, clinical, biological, and imaging data to support the development of mechanistic models of alpha synuclein propagation. In parallel, preclinical studies in GBA PD mouse models and wild type mice will be used to investigate how changes in PD-related pathology (alpha-synuclein and tau) relates to behavior, brain imaging alterations and mitochondrial, axonal and synaptic damage. Animal model will also aid the validation of a new PET tracer that targets alpha synuclein (i.e., \[¹⁸F\]Syntacasyn). Together, human and preclinical studies are designed to provide a translational framework integrating molecular changes with brain network alterations and clinical heterogeneity in PD.

Terazosin And Metabolic Energetics in Parkinson's Disease

This study investigates if Terazosin can improve metabolism in PD.

Mild Cognitive Impairment Community Screening and Early Intervention Via Stem Cell Therapy and Wearable Brain Computer Interface Device.

This study aims to evaluate the efficacy of community-based early detection and targeted interventions, including stem cell therapy and wearable non-invasive brain-computer interface (BCI) devices, for Mild Cognitive Impairment (MCI) in adults aged 55 years and older residing in U.S. urban and suburban communities. Primary objectives include assessing improvements in MCI detection rates, cognitive outcomes, and progression delay compared to standard care.

Remote Haptic Rehabilitation for Parkinson's Disease

Individuals with Parkinson's Disease (PD) often have motor difficulties that can negatively impact daily activities and their quality of life. Research has shown that to slow the progression of these symptoms, patients should partake in effective physical rehabilitation. However, effective physical rehabilitation has many barriers, including timing, cost, and other personal or system-level challenges. The purpose of this study is to evaluate the haptic remote rehabilitation system for patients with PD using a randomized controlled trial (RCT) in a field environment.

Investigating Subcortical Contributions to Speech Sequencing in Deep Brain Stimulator Recipients

This study will examine how two important brain circuits - one involving the subthalamic nucleus (STN) and one involving the ventral intermediate nucleus of the thalamus (VIM) - contribute to learning and producing speech sequences. Participants will include two groups: 1. individuals with Parkinson's disease who have deep brain stimulation (DBS) devices targeting the STN and 2. individuals with essential tremor who have DBS devices targeting the VIM. Participants will complete speech tasks involving the learning and repetition of novel sound sequences. During some parts of the study, DBS stimulation will be temporarily turned on or off in a controlled research setting. This will allow researchers to examine how stimulation affects both the learning of new speech sequences and the production of previously learned sequences. All STN participants and most VIM participants will also be equipped with a cutting-edge DBS system, the Percept PC, which will enable the recording of deep brain activity during the tasks. The results of this study will improve our understanding of how different brain circuits support speech learning and production. In particular, this study will help to differentiate the roles of the STN and VIM in learning the ordering of speech sounds within a syllable from learning of speech sequences containing multiple syllables. This knowledge may help guide future approaches to optimizing DBS settings to improve both movement and speech outcomes in individuals with neurological disorders, as well as provide greater general insight into how these brain structures contribute to speech production and learning.

Coordinated Reset Deep Brain Stimulation for Parkinson's Disease

Deep brain stimulation (DBS) is a surgical implant procedure for the treatment of Parkinson's Disease (PD) utilizing medical devices approved by the FDA. A novel approach to current DBS approaches is called "Coordinated Reset" DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS (T-DBS) that uses continuous high amplitude and high frequency stimulation. This study will evaluate the safety and short-term efficacy of CR-DBS in PD. The results from this study will significantly advance the development of CR-DBS for the treatment of PD. Findings in this study will also provide the rationale for further development of this novel DBS approach for other neurological and psychiatric disorders.

Shanghai Clinical Cohort - Parkinson's Disease (Reserve)

The goal of this observational cohort studyis to establish a high-quality clinical cohort of Parkinson's disease (PD) and multiple system atrophy (MSA) patients in Shanghai, in order to improve early diagnosis, precise subtyping, disease monitoring, and to provide a resource for translational research and novel therapy development. The main questions it aims to answer are: * Can multimodal data (clinical, imaging, electrophysiology, biospecimens, and genetics) help identify early biomarkers for PD and MSA? * Can precise subtyping and long-term monitoring predict disease progression and therapeutic response? Researchers will compare 600 PD patients and 100 MSA patients to evaluate differences in clinical features, biomarkers, imaging, and prognosis. Participants will: * Provide informed consent and complete baseline demographic and medical history collection. * Undergo standardized clinical evaluations, including motor and non-motor symptom scales, cognitive and quality-of-life assessments. * Provide biological samples (blood, saliva, optional CSF). * Receive brain imaging (MRI, optional PET/SPECT) and electrophysiological recordings (EEG, fNIRS). * Participate in longitudinal follow-up visits every 6 months for repeat assessments. This study will create a sustainable, multicenter, and sharable cohort platform to support early identification, personalized intervention, and therapeutic development for neurodegenerative diseases

IMPACT 360 for Parkinson's Disease

The IMPACT 360 study will evaluate the effects of a combined intervention of exercise, mindfulness, and nutrition on 8 key indicators of health and the mechanisms that drive these changes. 60 subjects aged 40 to 85 with a current diagnosis Parkinson's disease will be recruited. This study will follow a partial crossover design. All participants will receive the intervention. Participants randomized into the intervention group after their baseline screening will receive the 6-month intervention. Those randomized into the waitlist group will complete another assessment at the end of the 6-month care as usual phase before receiving the intervention.

The Influence of Vibrotactile Stimulation on Self-selected Walking Speed in People With Parkinson's Disease

The study tests whether a smart shoe (NUSHU) that provides vibrotactile stimulation can improve walking speed in people with Parkinson's disease. Sixteen participants complete two short walking tests-with and without vibration-to compare gait speed, cadence, stride length, usability, and safety. It is a low-risk pilot study meant to generate first evidence for future research.

Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach

The goal of this clinical trial is to learn if the medication atomoxetine can reduce freezing of gait in people with Parkinson's disease. The main questions it aims to answer is: Does atomoxetine reduce the frequency or severity of freezing of gait? What role does noradrenaline play in freezing of gait? Researchers will compare atomoxetine to a placebo to see if atomoxetine can improve freezing of gait in people with Parkinson's disease. Participants will: Visit the study site for measurements Take atomoxetine or placebo Perform walking assessments and undergo MRI Complete questionnaires about anxiety, stress, and quality of life

Movement State-dependent Adaptive DBS for PD

This is a single-center clinical study aiming to improve gait functions in patients with Parkinson's Disease (PD) by using adaptive neurostimulation to the pallidum. The investigators will use a bidirectional deep brain stimulation device with sensing and stimulation capabilities to 1) identify neural biomarkers to detect the onset of walking by recording neural activities from the motor cortical areas and the globus pallidus, 2) understand the impacts of changes in DBS parameters on gait kinematics and optimize setting parameters for enhancing walking performance, 3) develop a movement state-dependent adaptive deep brain stimulation (DBS) paradigm to automatically switch stimulation settings according to different movement states (i.e., walking vs non-walking). The proposed therapy will deliver personalized neurostimulation based on individual physiological biomarkers to enhance gait function in patients with PD. 6 patients with idiopathic Parkinson's disease who have already been implanted with the Medtronic Summit RC+S device will be enrolled in this study.

Untreated Parkinson's Disease Work-up Assessing Resident Microbiota and Duodenal Barrier Function

The UPWARD study is a prospective hypothesis-generating study in individuals with untreated Parkinson's disease (PD) and age-matched healthy controls (HCs). The objective of the study is to characterise disease-driven gastrointestinal (GI) changes that occur prior to initiation of treatment. The main questions this study aims to answer are: 1. Are there changes in duodenal permeability in people with untreated PD? 2. Are there changes in the gut microbiome in people with untreated PD? 3. Are these gut changes linked to prodromal features, or movement and non-movement symptoms of PD? The study consists of a screening visit, followed by a six-day home phase and one subsequent study visit at UZ Leuven. During the home phase, participants collect a stool sample, ingest radiopaque markers to assess gut transit time, and complete questionnaires. During the study visit, participants undergo an abdominal X-ray, a clinical assessment, and blood sampling. An upper GI endoscopy with duodenal biopsies is offered as an optional component of the study. This study does not test a therapeutic intervention. Examinations as part of the study are not standard clinical care. The findings are expected to improve understanding of early GI involvement in PD and to inform future mechanistic and clinical research.

LIFUS For Neurological Disorders

Low intensity focused ultrasound (LIFUS) has the potential to be used as a means of non-invasive neuro-modulation. To this day, the use of LIFUS is under investigation. Studies in healthy subjects have shown that application of LIFUS to the motor region of the brain can mildly decrease neuron excitability in healthy controls. The purpose of the present study is to evaluate the effects of LIFUS on brain tissue excitability in patients with movement disorders in order to elucidate the therapeutic potential of LIFUS.

Effects of Vagal Nerve Stimulation on Leg Muscle Activity and Posture in Parkinson's Disease

This study is designed to better understand the mechanisms contributing to impaired activation of leg muscles in people with Parkinson's disease (PD) and to test if stimulation of a nerve at the neck can improve muscle activation, walking and balance.

Quantification of Hsp90 in the Human Brain

This study tests the radiolabeled molecule ("tracer"), \[¹¹C\]HSP990, using positron emission tomography (PET) imaging to assess whether it can be used to measure levels of Heat Shock Protein 90 (Hsp90). The protein Hsp90 plays an important role in how proteins in the brain fold into their three-dimensional structure and how this protein helps maintain cellular homeostasis. Since neurodegenerative diseases such as Alzheimer's disease (AD), Parkinson's disease (PD), and amyotrophic lateral sclerosis (ALS) are characterized by disrupted three-dimensional protein folding resulting in protein aggregation, we also aim to measure Hsp90 levels in patients with these conditions. \[¹¹C\]HSP990 is a promising tracer for this purpose and has already been extensively tested in animal models with safe and favorable results. The investigator now aims to evaluate this tracer in the human brain in healthy volunteers as well as in patients with Parkinson's disease, Alzheimer's disease and amyotrophic lateral sclerosis. The investigator expects that Hsp90 protein levels will be present at reduced concentrations in patients, possibly in different brain regions depending on the distribution of the disease-causing proteins associated with these disorders. Since the discovery of the important role of Hsp90 in neurodegenerative diseases, several candidate drugs targeting Hsp90 have been developed in recent years. The imaging method used in this study may support the development of Hsp90-targeting medications by enabling measurement of Hsp90 levels in the brain and assessment of the effects of these drugs.

Pilot Study of Robotic Spinal Mobilization in Parkinson's Disease

This interventional pilot study will evaluate the safety and clinical efficacy of robotic spinal mobilization in community-dwelling adults with Parkinson's Disease (PD). The primary objective is to determine if the mechanical release of axial rigidity using the BackHug device correlates with measurable improvements in functional mobility and postural stability. Participants will be prospectively recruited and assigned to receive a standardized course of robotic therapy. The intervention consists of a series of 40-minute sessions administered over a defined observation period. The device features 26 robotic therapeutic heads designed to deliver targeted deep-tissue mobilization to the paraspinal muscles and intervertebral joints of the thoracic and lumbar spine. Key outcomes will be assessed using a repeated-measures design. Functional mobility (3-Meter Timed Up and Go) and functional strength (30-Second Sit-to-Stand) will be measured immediately before and after specific sessions to quantify acute therapeutic effects. Additionally, subjective metrics for chronic back pain (VAS) and sleep quality will be monitored to assess longitudinal benefits. This study aims to validate non-invasive mechanical mobilization as a scalable adjunct therapy for managing the 'axial' symptoms of Parkinson's Disease.

Comprehensive Assessment of Neurodegeneration and Dementia

This is a longitudinal observational study recruiting individuals between the ages of 50 and 90 with different types of dementia as well as a comparison group without cognitive deficits. Participants are/will be recruited at sites across Canada and will undergo assessments, neuroimaging, and biological sample collection.