Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide...
Essential TremorThe goal of this clinical study is to compare ulixacaltamide and placebo treatment in essential tremor. The main question it aims to answer is: • Is ulixacaltamide a safe and efficacious treatment for patients with essential tremor? Participants will be asked to participate in one of two clinical studies where they will be treated with either ulixacaltamide or placebo for a period of up to 12 weeks. After the controlled study completion, they will be eligible to participate in a long-term, open-label safety study and be treated with ulixacaltamide.
Optimization of VIM Targeting in Essential Tremor Surgery
Essential TremorDeep brain stimulation (DBS) for essential tremor is based on the intermedius ventralis nucleus of the thalamus (VIM) stimulation. This structure is however very difficult to target, as it remains invisible on imaging. The current procedure based on awake surgery with clinical and electrophysiological testings has several limitations that lead us to develop a probabilistic model to locate precisely the target. This study aims to show that asleep DBS surgery based on this new targeting method leads to at least the same clinical results than the classical procedure.
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's DiseaseEssential Tremor1 moreBackground: - Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these areas helps to block the nerve signals that cause abnormal movements. Researchers also want to record the brain function of people with movement disorders during the surgery. Objectives: To study how DBS surgery affects Parkinson s disease, dystonia, and tremor. To obtain information on brain and nerve cell function during DBS surgery. Eligibility: - People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia. Design: Researchers will screen patients with physical and neurological exams to decide whether they can have the surgery. Patients will also have a medical history, blood tests, imaging studies, and other tests. Before the surgery, participants will practice movement and memory tests. During surgery, the stimulator will be placed to provide the right amount of stimulation for the brain. Patients will perform the movement and memory tests that they practiced earlier. After surgery, participants will recover in the hospital. They will have a followup visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be programmed and adjusted over weeks to months to find the best settings. Participants will return for followup visits at 1, 2, and 3 months after surgery. Researchers will test their movement, memory, and general quality of life. Each visit will last about 2 hours.
Deep Brain Stimulation (DBS) Data Base Study
Parkinson's DiseaseEssential TremorThe primary goal of this study is to evaluate and compare outcomes, trends, and effectiveness of both awake and asleep Deep Brain Stimulation (DBS) surgical treatments, target selection, targeting accuracy and outcomes in patients with Parkinson's disease and Essential tremor.
Deep Brain Stimulation (DBS) Retrospective Outcomes Study
Parkinson DiseaseEssential Tremor1 moreThe primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.
Using Wearable and Mobile Data to Diagnose and Monitor Movement Disorders
Essential TremorParkinson Disease5 moreThe purpose of the research is to better understand the motor behavior of individuals in health and disease. The specific purpose of this project is to identify if we can utilize a smartphone to diagnose different movement disorders and monitor their symptoms. A. Objectives Estimate symptom severity of Essential tremor (ET), Parkinson's disease (PD), Huntington's disease (HD), Primary focal dystonia (PFD), spinocerebellar ataxia (SCA), and Functional movement disorders (FMD) using a smartphone-based application Differentiate individuals with the different movement disorders from healthy controls based on features from the smartphone data Differentiate individuals with a specific movement disorder from people with other movement disorders based on features from the smartphone data B. Hypotheses / Research Question(s) We hypothesize that we can estimate the severity of symptoms using a smartphone application and that, using those estimates, we can differentiate individuals with movement disorders from healthy controls and from people with other movement disorders.
Physiological Brain Atlas Development
Parkinson's DiseaseObsessive Compulsive Disorder3 moreThe NIH grant has funded the development of a physiological brain atlas registry that will allow us to significantly improve the data collectioin and use of physiological data into a normalized brain volume. This initially was used to improve DBS implants for Parkinson's Disease, Dystonia, Essential Tremor, and OCD, but now includes data acquired during all stereotactic brain procedures.
Clinical Outcomes for Deep Brain Stimulation
Parkinson DiseaseEssential Tremor1 moreThe object of this study is to longitudinally collect clinical outcomes of patients receiving deep brain stimulation for movement disorders with the objective of making retrospective comparisons and tracking of risks, benefits, and complications.
Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)
Essential TremorTo compile characteristics of real-world outcomes for Boston Scientific Corporation's commercially approved Deep Brain Stimulation (DBS) Systems, when used according to the applicable Directions for Use, for the treatment of Essential Tremor.
GyroGlove Use in Essential Tremor Patients
Essential TremorThis is a multi-centre, single-blind, placebo-controlled trial with an open label follow up. After the baseline assessment, all participants will receive the GyroGlove for two weeks during the open label follow up part of the trial. All gloves will be retrieved and returned to GyroGear after closure of the study.