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Essential Tremor clinical trials

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NCT ID: NCT03688685 Completed - Essential Tremor Clinical Trials

A Clinical Study to Evaluate CAD-1883 in Essential Tremor

Start date: January 23, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label study designed to evaluate the safety, tolerability and efficacy of CAD-1883, a positive allosteric modulator of the SK channel, administered twice daily orally to adult patients with ET. Patients with the diagnosis of ET based on the Movement Disorder Society (MDS) criteria with a documented severity of tremor based on the clinician-administered TETRAS Performance Subscale are eligible to be enrolled in the study.

NCT ID: NCT03638479 Completed - Parkinson Disease Clinical Trials

Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement Disorders

Start date: January 8, 2019
Phase:
Study type: Observational

This observational and experimental study seeks to establish a Smart Device System (SDS) to monitor high-resolution handtremor-based data using Smartphones, SmartWatches and Tablets. By doing this, movement data will be analyzed in depth with advanced statistical and Deep-Learning algorithms to identify new clinical phenotypical characteristics Parkinson's Disease and Essential Tremor.

NCT ID: NCT03597100 Completed - Essential Tremor Clinical Trials

Prospective Study for Symptomatic Relief of ET With Cala Therapy

PROSPECT
Start date: December 14, 2018
Phase: N/A
Study type: Interventional

Prospective, multi-center, single-arm, non-significant risk study designed to evaluate the Cala TWO device. Subjects will be screened for eligibility and fitted with a Cala TWO device. Subjects will wear the device at home for a period of 3 months, during which they will be asked to stimulate their dominant hand twice a day. The stimulation amplitude will be based on each subject's stimulation threshold. Subjects will have in clinic assessments at enrollment, month 1 and 3.

NCT ID: NCT03337334 Completed - Tremor, Limb Clinical Trials

Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor

Start date: June 2016
Phase: N/A
Study type: Interventional

Transcranial alternating current stimulation (tACS) is a noninvasive neuromodulation method that works by passing alternating electric current between electrodes where at least one of them is attached to the head. While tACS applied over the motor cortex at the general applied amplitude (1 mA) and using patch electrodes has been shown to entrain physiological tremor in healthy volunteers, the aim of this study is to test the feasibility of using high-amplitude tACS and to assess the effect of different electrode montages and stimulation sites in entraining physiological tremor. First, 10 subjects (arm 1) will be stimulated with 2 mA current amplitude applied between saline soaked patch square electrodes and comparison will be done between motor cortex stimulation and peripheral cortex stimulation. Then, 10 subjects (arm 2) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes and 5 mA amplitude and comparison will be made between motor cortex and occipital cortex stimulation. Three outcome measurements will be measured during the experiments which are: tremor entrainment, phosphene intensity and phosphene threshold.

NCT ID: NCT03300193 Completed - Tremor Clinical Trials

The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease

MRgFUS
Start date: May 2016
Phase: N/A
Study type: Observational

The study will investigate Essential Tremor and Parkinson's Disease patients who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS). We will evaluate the effect of lesion characteristics on tremor and on quality of life after the procedure as compared with the baseline prior to the procedure.

NCT ID: NCT03152136 Completed - Essential Tremor Clinical Trials

A Pilot Study of the Cala ONE Device for Essential Tremor

EXCITE
Start date: July 26, 2017
Phase: N/A
Study type: Interventional

Prospective, multi-center, randomized, controlled study designed to evaluate safety and repeatable effectiveness. Subjects will be randomized 2:1:1 to transcutaneous afferent patterned stimulation (TAPS), sham, or 'no intervention', respectively. Subjects randomized to the TAPS and sham arms will be blinded to their randomization assignments for the first two weeks of participation (controlled phase). After the first two weeks, all subjects will be crossed over to TAPS (open-label phase) for 2 weeks. During study participation, all subjects are to remain on a stable dosage of medications prescribed for the treatment of essential tremor, if applicable.

NCT ID: NCT03101241 Completed - Essential Tremor Clinical Trials

A Phase 2 RCT Study of CX-8998 for Essential Tremor

Start date: August 29, 2017
Phase: Phase 2
Study type: Interventional

This is a multicenter, double-blind, placebo-controlled, parallel-group study consisting of a screening period of up to 4 weeks (with the exception of participants on primidone at baseline who will be allowed 6 weeks of screening to allow for safe discontinuation). Screening results from all patients meeting the eligibility requirements will be further assessed by the sponsor medical personnel for final approval of suitability for inclusion in the study. Randomized participants will enter a 4 week double-blind dose-titration treatment period, followed by a 1 week safety follow-up period following the last dose of study medication, and a scheduled follow-up safety telephone call one week later.

NCT ID: NCT03051178 Completed - Essential Tremor Clinical Trials

Wearable Sensor for Responsive DBS for ET

Start date: September 18, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is evaluate the effectiveness and safety of a possible new treatment for Essential Tremor (ET) using external wearable sensors, which have the capability of recording acceleration and Electromyography (EMG). This therapy is called Responsive Deep Brain Stimulation (R-DBS). R-DBS systems will communicate with a computer, and apply stimulation when the computer detects patterns associated with tremor. This detection will suppress pathological activity and improve or alleviate the tremor. Currently, DBS is approved for the treatment of ET; however, stimulation is delivered continuously even when tremor or other symptoms are absent. Continuous DBS can lead to unwanted side effects such as stuttering and gait\balance problems. On the other hand, R-DBS will turn on only if activity associated with ET from the external sensors is detected.

NCT ID: NCT03041714 Completed - Essential Tremor Clinical Trials

Neurophysiologic Study of Patient With Essential Tremor and Dystonic Tremor

Start date: April 7, 2017
Phase:
Study type: Observational

Background: Essential tremor is when a person has tremor, but no other neurological symptoms. Dystonic tremor is when a person also has dystonia. Dystonia is a condition in which muscle contraction causes changes in posture. Researchers do not fully know what areas of the brain cause these tremors, or how the types differ. They also do not know what tests can identify the differences. Objective: To look at differences between essential tremor and dystonic tremor. Eligibility: People ages 18 and older with or without tremor Design: Participants will be screened with medical history, physical exam, and urine tests. Those with tremor will complete questionnaires about how tremor affects them. The screening and study visits can be done on the same day or on separate days. Participants will have 1 or 2 study visits. These include magnetic resonance imaging (MRI) and tremor testing. For MRI, participants will lie on a table that slides in and out of a cylinder that takes pictures. Sensors on the skin measure breathing, heart rate, and muscle activity. This takes about 2 hours. Tremor testing will include transcranial magnetic stimulation (TMS), electrical stimulation of the fingers, doing a movement task, and recording of tremor movements. For TMS, two wire coils will be held on the scalp and a brief magnetic field will be produced. A brief electrical current will pass through the coils. For the other tests, small sticky pad electrodes will be put on the skin. Participants will move their hand when they hear a sound. They will get weak electrical shocks to their fingers. These tests will take 3-4 hours. Participants can take part in either or both parts of the study.

NCT ID: NCT03027310 Completed - Parkinson Disease Clinical Trials

Clinical and Physiological Studies of Tremor Syndromes

Start date: May 5, 2017
Phase:
Study type: Observational

Background: Researchers have some data on how the brain controls movement and why some people have tremor. But the causes of tremor are not fully known. Researchers want to study people with tremor to learn about changes in the brain and possible causes of tremor. Objective: To better understand how the brain controls movement, learn more about tremor, and train movement disorder specialists. Eligibility: People ages 18 and older with a diagnosed tremor syndrome Healthy volunteers ages 18 and older Design: Participants will be screened with: - Medical history - Physical exam - Urine tests - Clinical rating scales - Health questions - They may have electromyography (EMG) or accelerometry. Sensors or electrodes taped to the skin measure movement. Participation lasts up to 1 year. Some participants will have a visit to examine their tremor more. They may have rating scales, EMG, and drawing and writing tests. Participants will be in 1 or more substudies. These will require up to 7 visits. Visits could include the following: - EMG with accelerometry - Small electrodes taped on the body give small electric shocks that stimulate nerves. - MRI: Participants lie on a table that slides into a cylinder that takes pictures of the body while they do simple tasks. - Small electrodes on the scalp record brain waves. - A cone with detectors on the head measures brain activity while participants do tasks. - A wire coil held on the scalp gives an electrical current that affects brain activity. - Tests for thinking, memory, smell, hearing, or vision - Electrodes on the head give a weak electrical current that affects brain activity. - Photographs or videos of movement Participant data may be shared with other researchers.