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Essential Tremor clinical trials

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NCT ID: NCT04502550 Recruiting - Parkinson Disease Clinical Trials

Brain Networks and Consciousness

Start date: October 15, 2020
Phase:
Study type: Observational

General anesthesia (GA) is a medically induced state of unresponsiveness and unconsciousness, which millions of people experience every year. Despite its ubiquity, a clear and consistent picture of the brain circuits mediating consciousness and responsiveness has not emerged. Studies to date are limited by lack of direct recordings in human brain during medically induced anesthesia. Our overall hypothesis is that the current model of consciousness, originally proposed to model disorders and recovery of consciousness after brain injury, can be generalized to understand mechanisms of consciousness more broadly. This will be studied through three specific aims. The first is to evaluate the difference in anesthesia sensitivity in patients with and without underlying basal ganglia pathology. Second is to correlate changes in brain circuitry with induction and emergence from anesthesia. The third aim is to evaluate the effects of targeted deep brain stimulation on anesthesia induced loss and recovery of consciousness. This study focuses on experimentally studying these related brain circuits by taking advantage of pathological differences in movement disorder patient populations undergoing deep brain stimulation (DBS) surgery. DBS is a neurosurgical procedure that is used as treatment for movement disorders, such as Parkinson's disease and essential tremor, and provides a mechanism to acquire brain activity recordings in subcortical structures. This study will provide important insight by using human data to shed light on the generalizability of the current model of consciousness. The subject's surgery for DBS will be prolonged by up to 40 minutes in order to record the participant's brain activity and their responses to verbal and auditory stimuli.

NCT ID: NCT04501484 Active, not recruiting - Essential Tremor Clinical Trials

Bilateral Essential Tremor Treatment With FUS

BEST-FUS
Start date: July 8, 2020
Phase: N/A
Study type: Interventional

Combined Phase II/III, multi-center, prospective, single-blinded trial. Ten (10) patients with who previously underwent successful and uncomplicated MRgFUS thalamotomy for essential tremor will undergo a contralateral treatment. The incidence of side effects will be determined at 1 and 3 months postoperatively, graded per the CTCAE v5 and analyzed by a data safety monitoring board. Upon successful review, this Phase II trial will be converted to a Phase III trial of utility that will enrol 40 additional patients. The primary outcome will be the change in QUEST score at 12 months postoperatively, as well as a patient-reported assessment of Health Utility. Secondary outcomes will include objective tremor, gait and speech assessments (filmed and scored by blinded evaluators), as well as quality of life questionnaires and adverse events questionnaires. Outcomes will be assessed immediately after the procedure, as well as 1, 3, 12, 24 and 36 months post-operatively.

NCT ID: NCT04501133 Recruiting - Parkinson's Disease Clinical Trials

Sensory-specific Peripheral Stimulation for Tremor Management

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to understand the neurophysiological mechanisms of peripheral electrical stimulation (PES) in modulating supraspinal tremorogenic input to motoneurons. For this purpose, the investigators will use transcutaneous PES, high-density electromyography (HD-EMG), transcranial magnetic stimulation (TMS), electroencephalography (EEG), magnetic resonance imaging (MRI), and neuromusculoskeletal modelling. This study will be carried out in both healthy participants and patients with essential tremor (ET) and Parkinson's disease (PD).

NCT ID: NCT04361955 Completed - Healthy Clinical Trials

Modulatory Effects of Deep Brain Stimulation on Cerebral Cortical Activity

Start date: January 31, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to learn about how deep brain stimulation (DBS) affects brain activity in those with Parkinson's disease (PD) and essential tremor (ET). The effect of therapeutic and non-therapeutic stimulation settings will be assessed. Additionally, DBS effects in the presence and absence of anti-PD medication will be studied. Also of interest are differences in stimulation effects while at rest versus while performing a task.

NCT ID: NCT04305275 Completed - Essential Tremor Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Tolerability of SAGE-324 in Participants With Essential Tremor

Start date: May 19, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2, double-blind, placebo-controlled study to evaluate the safety and efficacy of SAGE-324 compared to placebo on upper limb (UL) tremor reduction in individuals with essential tremor (ET).

NCT ID: NCT04286308 Recruiting - Parkinson Disease Clinical Trials

Cortical-Basal Ganglia Speech Networks

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

In this research study the researchers want to learn more about brain activity related to speech perception and production.

NCT ID: NCT04283812 Withdrawn - Parkinson Disease Clinical Trials

New Stereotactic Frame System for Neurosurgery

Start date: January 2023
Phase: N/A
Study type: Interventional

This study is designed to demonstrate an in-house developed re-attachable stereotactic system that can markedly reduce the overall deep brain stimulation (DBS) procedure time to greatly facilitate subject access to neurosurgical restorative therapies. Subjects will consist exclusively of individuals who have been approved to undergo deep brain stimulation surgery for the treatment of a neurological disorder at Mayo Clinic - Rochester MN. This study is a quantitative comparative, between-subject study enrolling approximately 10 subjects.

NCT ID: NCT04265209 Recruiting - Parkinson Disease Clinical Trials

[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor

Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

Clinical study to demonstrate an at least equivalent performance of a new PET molecular Imaging radiopharmaceutical named [18F] LBT-999 in brain imaging compared to the SPECT reference method named [123I]-FP-CIT to establish the differential diagnosis between Parkinson's Disease and Essential Tremor.

NCT ID: NCT04260971 Recruiting - Essential Tremor Clinical Trials

Cyclic Deep Brain Stimulation in Essential Tremor

Start date: February 25, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to prove the efficacy and safety of cyclical deep brain stimulation (DBS) in patients with essential tremor, and demonstrate non-inferiority of cyclical DBS on tremor control when compared to continuous stimulation.

NCT ID: NCT04231487 Recruiting - Parkinson Disease Clinical Trials

Using Wearable and Mobile Data to Diagnose and Monitor Movement Disorders

Start date: June 27, 2019
Phase:
Study type: Observational

The 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 1. 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 2. Differentiate individuals with the different movement disorders from healthy controls based on features from the smartphone data 3. 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.