Clinical Research Directory

Investigating Adaptive Deep Brain Stimulation in Parkinson's Disease Management

The goal of this prospective, multi-center, randomized, double-blind, crossover clinical trial is to evaluate the effectiveness and safety of adaptive DBS (aDBS) and conventional DBS (cDBS) delivered through the AlphaDBS system, in levodopa-responsive Parkinson's disease subjects. Data from previous studies conducted in Europe indicate that the use of the AlphaDBS system is safe and effective in both aDBS and cDBS modes. However, such studies suggest that aDBS may lead to more ON-time without troublesome dyskinesias in some patients. The study is designed to first demonstrate safety of effectiveness of cDBS, then to directly compare effectiveness of aDBS relative to cDBS. Subjects enrolled in the study will undergo multiple visits to assess the improvement of PD symptoms and will be randomized to Mode 1 for three months, followed by Mode 2. At the end of Mode 2, subjects will select their preferred mode, which will be maintained for 3 additional months. Subjects will complete patient diaries at different time points to evaluate their symptoms throughout the day.

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.

An Exploratory Clinical Study of UX-DA001 in Subjects With Idiopathic Parkinson's Disease

This clinical study is designed to explore the safety and tolerability of UX-DA001. It will also explore if UX-DA001 works to improve motor function in subjects with Parkinson's disease. UX-DA001 manufactured from participant's own cells will differentiate into mature dopaminergic neurons after being transplanted into the brain of the participant.

A High-density Microelectrode for Human Neuronal Recordings

The purpose of this study is to test the ability of a newly-designed electrode to measure the activity of individual nerve cells (neurons), and collections of nerve cells (local field potentials) in the brain. The study's main goals are to see how well this electrode works compared to standard electrodes and to validate its safety.

Video-oculography and Parkinson's Disease

This study aims to study, in patient with Parkinson's disease, mild to moderate stage (according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease, Postuma et al., 2015): * the evolution of oculomotricity markers over time. * the correlation between neurological evaluations (motor and non-motor scores), neuropsychological evaluations (cognitive disorders) and oculomotricity evaluation, over a follow-up period of 7 years. * the impact of antiparkinsonian drugs on the evolution of oculomotricity assessment by video-oculography. * the value of oculomotricity assessment by video-oculography as an evolutionary marker of the disease.

Integration of Augmented Visual Feedback in Action Observation and Motor Imagery Therapy for Parkinson's Disease

Improving movement control during rehabilitation is still a challenge for people with Parkinson's Disease, mainly because of the motor symptoms caused by the condition. However, new technologies offer promising ways to support therapy. This clinical trial will test whether using TecnoBody® D-Wall technology integrated with two techniques (Action Observation and Motor Imagery) can improve physiotherapy outcomes for people with Parkinson's Disease. The TecnoBody® D-Wall is a type of digital mirror that includes a 3D camera, pressure-sensitive platforms, and a screen. It shows a person's body movements in real time and gives visual feedback on joint mobility, balance, and how weight is distributed during movement. Action Observation and Motor Imagery are two techniques already used in physiotherapy. Action Observation involves watching someone perform a movement, while Motor Imagery involves mentally rehearsing the movement before doing it. Studies have shown that both techniques activate the same brain areas involved in actual movement. In this trial, after watching and imagining the movement, participants will perform the exercise in front of the D-Wall. This setup gives them real-time feedback to help improve how they move, a new approach for these techniques. To see if this approach works, we will measure balance using a test validated for people with Parkinson's Disease and assess mobility using lab-based gait analysis, which tracks how a person walks. Participants in the study will: * Be receiving routine physiotherapy at a hospital that is specialized in Parkinson's Disease rehabilitation. * Be randomly assigned to one of two groups: 1) One group will receive physiotherapy incorporating the D-Wall alongside Action Observation and Motor Imagery; 2) The other group will receive physiotherapy incorporating the D-Wall but, without Action Observation or Motor Imagery. * Take part in therapy for up to four weeks, followed by another four weeks of monitoring, for a total of up to two months. * Complete some initial tests to check if they are eligible for the study. This study includes patients who have been diagnosed with idiopathic Parkinson's Disease and are undergoing rehabilitation as part of their usual hospital care. The intervention lasts as long as their regular hospital stay.

The Impact of Deep Brain Stimulation on Speech and Swallow Function in Parkinson Disease

Nearly one-million people in North America are now living with Parkinson's disease (PD), and that number is projected to rise to nearly 1.2 million by 2030. With advancements in neuromodulatory technologies, increasingly more of these individuals elect to undergo deep brain stimulation (DBS) surgery in order to control symptoms of the disease, including refractory tremor, medication-induced dyskinesias, and PD-associated dystonia. The two most common DBS neural targets for controlling these symptoms are the globus pallidus internal segment (GPi) and the subthalamic nucleus (STN). Recent meta-analyses have shown relative equivalence between these two sites at controlling core PD symptoms. To date, there is not conclusive evidence regarding the potential impact of DBS to GPi or STN on laryngeal-mediated functions of voice, swallowing, and cough, and consequently no guidance on whether these outcomes should be considered when selecting DBS target. Therefore, the goal of this project is to determine the impact of DBS neural target (STN versus GPi), lead location within the target, laterality, and stimulation settings on voice, swallow and cough function in people with PD. The larynx is an important player in each of these functions, and our central hypothesis is that spread of stimulation to corticobulbar fibers in the genu of the internal capsule have deleterious effects on laryngeal motor control, resulting in voice, swallow, and cough dysfunction. We have identified three specific aims for this application: 1.) To compare laryngeal function during volitional voice tasks pre-post DBS, and when DBS placement is bilateral versus unilateral for STN and GPi targets. 2.) To compare laryngeal function during volitional and induced cough tasks pre-post DBS, and when DBS placement is bilateral versus unilateral for STN and GPi targets. 3.) To compare airway safety associated with laryngeal onset, degree, and duration of maximum closure during swallowing, pre-post DBS, and when DBS placement is bilateral versus unilateral for STN and GPi targets. These hypotheses were developed based on compelling published and unpublished preliminary data. We will accomplish these aims by enrolling people with PD who are being considered for DBS surgery. We will measure physiologic, functional, and quality of life parameters of voice, swallow and cough pre- and post-surgically. The realization of the proposed aims is significant because it will address a substantial gap in our understanding of DBS outcomes related to communication and airway protection, which are important in terms of morbidity, mortality, and quality of life for patients with PD. The translational potential to provide additional guidance to DBS surgical teams regarding whether voice, swallow or cough functions should be considered with selecting DBS target and/or laterality is high. Ultimately, the project fits squarely within the overarching goal of the research team to deliver the best possible care to people with PD.

SMART-PD: Evaluating the Impact of Smartphone-Based Wearable Technology on Motor Symptoms and Quality of Life in People With Parkinson's Disease

This study aims to evaluate whether wearable technology can improve the management of motor symptoms in people with Parkinson's disease (PD) who experience motor fluctuations throughout the day. The project will use a smartwatch and mobile app (KinesiaU) to continuously track movement, allowing for more responsive and personalized treatment compared to traditional monitoring methods. In this pilot randomized controlled trial, 32 participants will be assigned to either: A control group receiving standard care, or A wearable device group receiving standard care plus using the smartwatch. Outcomes will be assessed over a 4-week period, focusing on changes in motor function, quality of life, and self-management. The study will also examine feasibility, adherence, and data quality. If successful, this trial will provide critical evidence for integrating wearable devices into routine clinical care for PD, paving the way for larger efficacy trials and more patient-centered care strategies.

A Targeted Amino Acid Supplement for People With Parkinson's Disease

The goal of this clinical trial is to learn if an amino acid supplement that is specifically made for people with Parkinson disease can improve nutrition without interfering with dopamine medication in people living with Parkinson disease. The main question it aims to answer is: • Does an amino acid supplement that is specifically made for people with Parkinson disease have short-term improvements in nutrition deficiencies, while minimally interfering with Parkinson disease medication? Researchers will compare the short-term effects of this specialized nutrition supplement to a supplement that is available for everyone to purchase in a store (whey protein supplement-a milk by-product) and to an inactive supplement. Researchers will then check for the indicators of nutrition levels and the presence of dopamine medication in the blood. Researchers will also assess mood and movement abilities in participants. Participants will be asked to: * attend 4 study visits over the course of 4 weeks (initial orientation visit plus 3 intervention visits). * drink one of the 3 supplements (supplements will be mixed into water to create a beverage) at each of the 3 intervention visits. * participate in blood drawings and mood and movement assessments at each of the intervention visits. * engage in a phone call after each intervention visit to determine any delayed responses.

Mediterranean Diet Effects on Parkinson's Disease

Currently, there are no disease-modifying treatments for Parkinson's disease (PD), the second most common neurodegenerative disorder worldwide, making it crucial to find interventions that can change the disease's trajectory. Epidemiological studies suggest that the Mediterranean diet (MD) is linked to improved motor and non-motor symptoms, slower disease progression, and lower mortality in PD patients. However, few interventional studies have explored this connection. This study assesses whether an MD can improve motor and non-motor symptoms in PD patients. Additionally, the study will examine the effects of the diet on a patient's quality of life, gastrointestinal symptomatology, adaptive immune system, fecal and nasal microbiome, and fecal and urinary metabolomics. This is a randomized, controlled, non-pharmacological, single-center, masked trial with two parallel groups. It will evaluate the safety and efficacy of the MD on motor and non-motor symptoms reported by PD patients. Forty-four participants, aged 40-85, meeting the inclusion criteria will be enrolled and block-randomized into two groups: one maintaining their usual diet (control) and the other following a MD for six months (intervention). The primary outcome is patient-reported symptoms, measured using the MDS-UPDRS I+II score. Secondary outcomes include the analysis of adaptive immune system cells, nasal and fecal microbiome composition, and inflammatory and metabolic markers. Additional assessments include disease severity (MDS-UPDRS), non-motor symptoms (Non-Motor Symptoms Scale), participant well-being (36-Item Short Form Health Survey), gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale and Patient Assessment of Constipation Quality of Life), and the intensity of dopaminergic therapy (levodopa equivalents). Evaluations will be performed at baseline and after six months.

Step Up to PD: A Community-based Walking Program for People With Parkinson's Disease

This study will investigate the feasibility of a 6-month community walking program for people with Parkinson's disease (PD) and their care partners in greater Saint Louis, Missouri region. The walking program will consist of weekly, organized walking groups at the Missouri Botanical Gardens. Participants in the program will use Nordic walking poles during the walks. The walking group(s) will meet once per week and will be supervised by walking group leaders from Saint Louis University. Participants will be given a smart watch to wear that will help step counts will be tracked in real-time. The program is designed to get people with Parkinson's disease out of their homes, cultivate a culture of connection with others with Parkinson's disease, and to be collectively accountable for a common goal toward increasing their physical and social engagement in their communities.

Strength-Endurance Circuit Training in Parkinson's Disease

The goal of this clinical trial is to determine whether adding strength training to aerobic training has a comparable or greater effect on the clinical status of Parkinson's disease patients than a standalone aerobic training. \- Does combined strength-endurance circuit training provide added benefits to physical performance, disease severity, blood biomarkers, and quality of life in PD patients compared to standalone aerobic training? Participants will: * undergo outcome measurements before and after the 12-week intervention and a 3-month follow-up measurement, * visit the clinic twice a week for 1-hour training sessions. * selected patients will be given a smartwatch with a pedometer that will count their average number of steps before, during and after the training period

LFP Sensing From Directional Leads in the Acute Clinical Setting

This study plans to learn more about the optimal way to program the Medtronic Deep Brain Stimulation system in patients with Parkinson's Disease.

Vortioxetine for Depressive Symptoms and Freezing of Gait in Parkinson Disease

The present study involves patients with Parkinson Disease (PD) suffering from freezing of gait (FOG) and depressive symptoms. The main aim of the study is evaluating the efficacy of vortioxetine in reducing moderate/severe FOG not responsive to dopaminergic treatment in patients with PD with depressive symptoms.

Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients

This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease.

A Novel Robotic System for Motor-cognitive Exercise for Patients With Parkinson's Disease

The objective of this study is to test a gamified rehabilitation system in a sitting position involving robots and music for the benefit of individuals with Parkinson's disease (PD). This pilot experiment will involve the collection of both subjective user evaluation measures and objective motor and cognitive measures.

Clinical Trail of Transcranial MR-guided Focused Ultrasound in the Treatment of Motor Symptoms in Patients with Parkinson' Disease

Randomized, double-blind, self-cross-over control (After the first visit, patients are divided into two groups, randomly receiving real stimulation/placebo stimulation. 10 days later, during the second visit, a cross-over occurs: patients who received real stimulation in the first visit will receive placebo stimulation in the second visit, and vice versa. The grouping situation remains blinded for the patients, TMS analysts, and video analysts.)

Ameliorating Effects and Mechanisms of TaVNS on Constipation in PD Patients.

The investigators intend to conduct a randomized, double-blind, sham-stimulation-controlled experiment, incorporating various clinical scales, gastrointestinal electrogram, and high-resolution anorectal manometry (HRAM), to investigate the improvement effect of taVNS on constipation symptoms in PD patients.

Parkinson Disease: A Model of National Digital Interventions to Prevent or Slow a Rise of Non-Communicable

According to Parkinson's Disease Medical Center of Excellence's project which was registered Parkinson's disease patients in 2008-2011, it was found that there were more than 60,000 people with Parkinson's disease in Thailand, approximately 1 over 3 of all elderly people. It is estimated that the prevalence of Parkinson's disease is approximately 242.57 per 100,000 people of all elderly people, and it is likely to increase due to the current situation of Thailand which is entering aging society. The current diagnosis of Parkinson's disease still relies heavily on medical history and physical examination. The accuracy of diagnosing Parkinson's disease by neurologists is approximately 80 percent, especially when they have been following up consistently. Nonetheless, if they have Parkinson's disease in the early stages, the signs and symptoms will not be severe. Therefore, diagnostic accuracy will decrease around 40-50 percent, making it difficult to diagnose Parkinson's disease patients at an early stage and as a consequence, there still are many undiagnosed patients in 2022. Consequently, Parkinson's Disease Medical Center of Excellence is planning to establish this pilot research project to develop and analyze advanced data of the screening system for people at risk and precursor symptoms to Parkinson's disease, Chulalongkorn Hospital, Thai Red Cross Society. Dividing patients into 3 groups, those who have precursor symptoms, who are at risk of developing disease and Parkinson's disease patients, using the digital platform on mobile application that includes general information, health information, congenital diseases, regularly used medications, initial abnormal symptoms, various risk factors, writing and handwriting, pronunciation assessments, and get diagnosis from experts for referral in the public health system.

Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication

The purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Participants will be followed for five years and make a total of five study visits.