1,260 Clinical Trials for Various Conditions
The goal of this clinical trial is two-fold. First to investigate the feasibility of whether a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation over a long period of time (24 months). Second, to explore the preliminary efficacy of exercise on markers for prodromal Parkinson's disease progression in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation. Participants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. A joint primary objective consists of two components. First to determine the longitudinal effect of an exercise intervention in LRRK2 G2019S or GBA1 N370S variant carriers on a prodromal load score, comprised of digital biomarkers of prodromal symptoms. The secondary component of the primary outcome is to determine the feasibility of a remote intervention study. The secondary objective is the effect of a physical activity intervention on digital markers of physical fitness. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD. Using these biomarkers, we aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United Kingdom are currently in preparation (Slow-SPEED-UK) and active in the Netherlands (Slow-SPEED-NL). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups
Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases, Basal Ganglia Diseases, Central Nervous System Diseases, Synucleinopathies, Nervous System Diseases, Cerebral Disorder, Brain Diseases, Parkinsonian Disorders, Genetic Predisposition
The goal of this clinical trial is to learn whether a personalized brain stimulation method called repetitive transcranial magnetic stimulation (rTMS), combined with walking exercises, is a practical and tolerable approach to help people with Parkinson's disease who experience freezing of gait (FOG). FOG is a disabling symptom where people temporarily feel stuck and unable to start walking, even though they want to move. The main questions this study aims to answer are: Can people with Parkinson's disease and FOG tolerate this combined rTMS and walking training procedure? Can researchers successfully enroll and retain participants for this multi-visit intervention? Does the combination of rTMS and gait training show early signs of improving gait and reducing freezing episodes? This study does not include a comparison or placebo group. All participants will receive the same intervention. Participants will: Attend up to 15 study visits over about 16 weeks, with the option to combine visits to reduce burden. Complete brain imaging (MRI) before and after the intervention to guide and evaluate treatment. Receive a form of brain stimulation (rTMS) using a safe, non-invasive coil placed over a specific part of the brain called the supplementary motor area (SMA). The target is personalized using each person's MRI data. Participate in walking exercises that include cognitive tasks (dual-task gait training) after each set of brain stimulation sessions. Undergo assessments of walking ability, Parkinson's disease symptoms, and brain response to stimulation. Be videotaped during walking tasks to assess gait changes, while wearing small motion sensors on the body. Complete questionnaires about symptoms, safety, and tolerability. This study is being conducted at the Medical University of South Carolina (MUSC) and includes up to 15 adults between the ages of 50 and 80 who have been diagnosed with Parkinson's disease and experience FOG. Although rTMS is already FDA-cleared for depression and other conditions, it has not been approved for freezing of gait, and its use in this study is considered investigational. The stimulation device used has been determined to be non-significant risk (NSR) by the FDA. The study does not offer direct medical benefit to participants, but results from this trial may help researchers develop future treatments and better understand how brain stimulation affects walking difficulties in Parkinson's disease. Participation is voluntary, and individuals can withdraw from the study at any time without affecting their medical care
Parkinson's Disease (PD)
A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease.
Parkinson Disease
Gait changes in Parkinson's disease are complex, variable, and difficult to detect during short clinic assessments. The aim of this study is to collect gait measurements in Parkinson's patients through sensors in a novel shoe device, NUSHU by Magnes AG. The shoe additionally provides vibrational feedback that can potentially help gait difficulties experienced by Parkinson's patients.
Parkinson's Disease (PD)
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.
Parkinson Disease, Idiopathic
Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).
Parkinsons Disease (PD)
The study looks to investigate the effects that light therapy delivered to the frontal cortex could have on Parkinson's disease related symptoms ( both cognitive and motor). The therapy is a non invasive technique that deliverers low level wavelength light to the front part of the head for 12 minutes. for this study the therapy will be done 3 times a week for 6 weeks. To measure the potential effects on the therapy in Parkinson symptoms, we will do a set of cognitive and motor test before and after the intervention to measure any changes as well as control for any potential markers such as age, sex, disease level, medication and exercise.
Parkinson Disease
People with Parkinson's disease often experience problems with 'gait' and balance. Gait refers to the way a person moves while walking, such as their speed and length of steps. People with Parkinson's may experience slowness of movement, shuffle their feet, or have periods of 'freezing', during which their feet feel like they are stuck to the floor. Some people may struggle to maintain their balance and fall. These symptoms are frequently disabling and can lead to a worse quality of life. The nervous system is your body's messaging system - it helps different parts of your body communicate with one another. Neurotransmitters are chemicals that deliver those messages from one part of the body to another. The purpose of this study is to determine if the use of ARICEPT (Donepezil hydrochloride) improves gait and balance and its relation to the size of an area of the brain called "Cholinergic Nucleus 4" (Ch4). The study team is also studying how degeneration (breakdown and eventual loss) in Ch4 contributes to problems with gait and balance. One way this may happen is through the loss of a chemical in the brain called acetylcholine. Acetylcholine is a neurotransmitter and its activity is associated with alertness, thinking, and the ability to move. Taking a drug that increases acetylcholine, such as ARICEPT, may improve gait and balance. By better understanding this relationship, we may be able to improve the treatment of gait and balance problems in the future.
Parkinson Disease
The goal of this observational and interventional study is to understand how therapeutic deep brain stimulation (DBS) affects attention, perception and cognition in participants with Parkinson's disease (PD) and essential tremor (ET). The main questions it aims to answer are: * Does impaired control of attention and eye movement in PD alter how social cues are perceived and interpreted? * Does therapeutic DBS improve or worsen attentional and perceptual deficits for social cues in PD and ET? * Can DBS be optimized to restore normal attentional control in PD while remaining an effective therapy for other aspects of the disorder. * What do parts of the brain targeted by DBS contribute to the control of attention? Using an eye tracking camera, investigators will study how participants with PD and ET look at and perceive facial expressions of emotion before and after starting DBS therapy, in comparison to a group of healthy participants without ET, PD or DBS. Participants with PD and ET will see and rate morphed facial expressions on a computer screen in three conditions: * Before starting DBS therapy (over approximately 1 hour). * In the operating room, during the standard procedure to implant DBS electrodes, while the participant is awake (for no more than 15 minutes). * After starting DBS therapy, with brief experimental changes of DBS stimulation level and frequency (over approximately 1 hour).
Essential Tremor, Parkinson's Disease (PD)
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.
Parkinson Disease, Parkinson Disease, Idiopathic
Inability to align and refocus the eyes on the objects at different depths, i.e., vergence impairment and strabismus, frequently affects the quality of life in patients with Parkinson's disease. The investigators study aims to understand the location-specific effects of subthalamic region deep brain stimulation on vergence and strabismus by integrating the patient-specific deep brain stimulation models and high-resolution eye-tracking measures. The knowledge gained will allow the investigators to find the most beneficial stimulation location and parameters for improving binocular coordination, strabismus, and vergence while preserving the ability to treat motor symptoms in Parkinson's disease.
Parkinson's Disease
This pilot study will evaluate the short-term (3 months) and long-term (6 months) effectiveness of a high-intensity interval training (HIIT) program in improving cognitive function and self-efficacy in individuals with PD.
Parkinson Disease
This trial is a randomized, double-blind, placebo-controlled Phase 1b study evaluating the safety/tolerability, PK, and pharmacodynamics of VENT 02, administered orally at 1 dose level twice daily (BID) over 28 days in patients with mild to moderate Parkinson's disease. The study includes a screening period, a 28-day double-blind treatment period, and a 7-day follow-up period after last dose. Approximately 30 patients will be randomized into 1 of the 2 treatment arms.
Parkinson Disease
The goal of this clinical trial is to learn if adaptive deep brain stimulation (DBS) can decrease or prevent freezing of gait in participants with Parkinson's disease.
Parkinson Disease
Listener training offers a promising avenue for improving communication for people with dysarthria due to Parkinson's disease by offsetting the intelligibility burden from the patient onto their primary communication partners. Here, we employ a repeated-measures, randomized controlled trial to establish the efficacy of listener training for patients with PD and their primary communication partners. This translational work will establish a new realm of clinical practice in which the intelligibility impairments in PD are addressed by training partners to better understand dysarthric speech, thus elevating communication outcomes and participation in daily life.
Dysarthria, Hypokinetic
The purpose of this study is to generate evidence of the safety, tolerability, and pharmacokinetics/pharmacodynamics of IV LY4006896 compared with placebo in healthy participants and participants with Parkinson's disease.
Parkinson Disease
The goal of this clinical trial is to learn whether home-based transcranial direct current stimulation (tDCS) is safe and practical for people aged 40 to 70 years with Parkinson's Disease. The study aims to find out if participants can use the tDCS device at home without serious side effects and whether it is easy for them to use on their own. Participants will first attend an in-person visit to learn how to use the tDCS device. They will then use the device at home once a day for 20 minutes over seven consecutive days. Video calls on days 2 and 3 will provide support and supervision. After each session, participants will complete brief online questionnaires about any side effects and how easy the device was to use. The study will also check if using tDCS at home improves motor symptoms in Parkinson's Disease by using a standard movement assessment.
Parkinson Disease
This study explores the use of multifunctional, non-invasive spinal cord transcutaneous stimulation (scTS) to address axial motor symptoms, particularly gait dysfunction, in Parkinson's disease (PD). These symptoms, resistant to levodopa and inadequately managed by deep brain stimulation (DBS), arise from maladaptive spinal network changes. A non-invasive approach like scTS could overcome limitations associated with invasive spinal cord stimulation (SCS), which requires surgical implantation and lacks adaptability in stimulation site adjustments. Gait dysfunction in PD stems from disrupted interactions between spinal and supraspinal networks. scTS provides a non-invasive alternative, shown to enhance locomotor functions in conditions such as spinal cord injury, stroke, and cerebral palsy. This study hypothesizes that scTS applied at multiple spinal levels-cervical (C3-C4), thoracic (T11-T12), and lumbar (L1, L2-L3)-can synergistically activate locomotor central pattern generators (CPGs) and improve gait and postural control in PD. Additionally, it is hypothesized that proprioceptive input, combined with scTS, can counteract disruptions in spinal networks and restore voluntary movement. The primary goal is to evaluate the effects of scTS on stepping performance, postural control, and locomotor recovery in PD. Specific objectives include: 1. Enhancing Locomotor Networks * Determine optimal scTS parameters for inducing rhythmic stepping in PD patients. * Assess interactions between spinal and supraspinal networks during imagined stepping under scTS in a gravity-neutral setting. 2. Improving Postural Networks o Evaluate the effectiveness of scTS in restoring postural control and integrating postural-locomotor functions. 3. Facilitating Neuroplasticity for Movement Recovery o Combine scTS with activity-based recovery training to promote adaptive plasticity in spinal and cortical networks, reducing freezing of gait (FOG). The research will measure scTS's capacity to generate coordinated stepping and postural movements, integrate proprioceptive feedback, and induce long-term improvements in gait parameters. By targeting spinal locomotor and postural systems, scTS offers a novel, non-invasive approach to addressing gaps in the management of PD gait dysfunction. This work has the potential to significantly enhance the quality of life for individuals with PD, providing a safe, adaptable, and patient-centered therapeutic solution.
Parkinson Disease
This project will focus on improving power in adults with Parkinson's disease, since power is related to performance of daily activities and memory and decision making. The study will compare traditional power training, where the participant does all exercises as fast as possible to top set resistance training, where the participant does power training, but it is preceded by warm-up sets that progress in weight until the participant reaches 90% of the person's maximum strength. If the top set method is better than traditional power training, it could be more beneficial than existing methods in improving independence in adults with Parkinson's disease.
Parkinson Disease
This is a expanded access use of allogeneic bone marrow-derived mesenchymal stem cells for a single subject with moderate Parkinson's disease that has progressed.
Parkinson Disease
The primary objectives of this study are to assess the efficacy of TB006 in improving motor function and to assess the safety of TB006 in participants with Parkinson's Disease (PD).
Parkinson's Disease (PD)
This is a research study investigating elevated homocysteine in the blood of patients with Parkinson's disease who are currently receiving treatment with levodopa. We are evaluating if elevated homocysteine can be corrected using open label B vitamin therapy, as well as the impact of homocysteine levels on cognitive function.
Parkinson&Amp;#39;s Disease
The primary purpose of this study is to evaluate efficacy and safety of CREXONT under real world conditions in participants with Parkinson disease (PD).
Parkinson Disease
The goal of this clinical trial is to learn if bezisterim can treat movement symptoms of Parkinson's disease in patients that are 45 to 80 years old, in generally good physical and mental health, and are nearing the need for treatment to relieve their symptoms but have not yet been prescribed any form of levodopa or drug with similar activity. The main questions it aims to answer are: * Will bezisterim decrease movement symptoms of Parkinson's disease? * What medical problems do participants have when taking bezisterim? Researchers will compare the effects of bezisterim treatment to placebo (a look-alike substance that contains no drug) to see if bezisterim works to treat movement symptoms of Parkinson's disease. Participants will * have a physical examination that includes an electrocardiogram * take drug or placebo twice daily for four months * visit a clinical site or receive an at home visit seven times over the course of five months
Parkinsons Disease (PD)
The Goal of this study is to evaluate the safety, tolerability, and clinical responses following implantation of DSP-1083. Study enrolls both male and female patients in 2 cohorts.This study will be held in approximately 5-6 study sites in North America
Parkinson's Disease
BLAAC PD is a research study to understand what Parkinson's disease looks like for Black and African American communities. BLAAC PD is happening at research centers around the United States. The study is part of the Global Parkinson's Genetics Program (GP2). GP2 is a research project working to transform understanding of the genetics of Parkinson's disease and make that knowledge globally relevant.
Parkinson Disease
When a patient gets DBS surgery, the neurosurgeon makes a hole in the skull through which they can put the DBS lead down in deep parts of the brain that help control movement. For this study, research participants will also have an ECoG strip put through the same hole (no extra holes are being made for research purposes). The ECoG strip is a little less than half an inch wide, and a little more than 2.5 inches long. It is very, very thin; it is a thin plastic film with flat metal sensors that can record the electrical activity in the brain. The ECoG strips are FDA approved. The neurosurgeon will slide the ECoG strip under the skull but on top of the brain, over another area of the brain that helps control hand/arm movement (motor cortex), so that the study team can record the activity there. The study team will record brain activity from the DBS lead and the ECoG strip simultaneously to try to understand how the brain communicates and sends information. The study team will check that the ECoG strip is in the right place by delivering a very small electrical pulse to the wrist. If the ECoG strip is in the correct location, this electrical pulse will show up on the brain activity being recorded by the sensors in the ECoG strip. Fluoroscopy (i.e. X-ray images that can be taken quickly) will also be done at the end of the surgery to help confirm the location of the ECoG strip. During fluoroscopy, an X-ray beam is used to track a contrast agent ("X-ray dye") through the body, so that the body can be seen in detail. This involves some radiation exposure for the participant, so this is described in the consent form. Patients who want to sign up for the study will not be allowed to do so if they have had other radiation exposures within the past year that would go over a safe limit when added to the amount of radiation expected from the fluoroscopy for this study.
Parkinson Disease
The goal of this clinical trial is to assess the safety and tolerability of the surgical transplantation of dopaminergic progenitor cells into the brains of participants with Parkinson's disease. The transplanted dopaminergic cells will be derived from the participant's own skin cells.
Parkinson Disease
The investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address "repair cell" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.
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 50-80 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. Participants will: • Take NEU-411 or placebo every day for 52 weeks
Parkinson Disease, Parkinson, Idiopathic Parkinson Disease, Early Parkinson Disease (Early PD), Parkinson Disease, Idiopathic