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Essential Tremor clinical trials

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NCT ID: NCT03795935 Recruiting - Essential Tremor Clinical Trials

Relief From Side Effects: Clinical Use of Electrodes With Direction

RESCUED
Start date: September 17, 2018
Phase: N/A
Study type: Interventional

Deep Brain Stimulation (DBS) uses electrical pulses sent through a lead (insulated wire) to help stop unwanted symptoms in a variety of brain diseases, including the tremor seen in patients with Essential Tremor (ET). The current standard lead allows this stimulation to spread out uniformly in all directions. As these diseases progress, however, the amount of electrical stimulation required to stop the symptom usually increases. This may become problematic because the increased electrical stimulation required for advanced symptoms may spread outside the desired targeted area, and effect other parts of the brain and causing unwanted side effects. A new type of DBS lead has been developed which can steer, or focus, the electrical stimulation in a given direction toward the desired target area and away from areas that would cause side effects. We would like to quantify the benefit seen in patients who have been switched from the traditional lead to this new directional lead.

NCT ID: NCT03794661 Not yet recruiting - Parkinson's Disease Clinical Trials

Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool

EVIDENT
Start date: February 28, 2019
Phase: N/A
Study type: Interventional

The objective of this clinical investigation is to characterize the clinical performance of Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or essential tremor (ET).

NCT ID: NCT03780426 Recruiting - Essential Tremor Clinical Trials

tSMS in Essential Tremor

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

This is randomized double-blind study to study the hypothesis that transcranial static magnetic field stimulation of the primary motor cortex improves tremor in patients with essential tremor. Half of the patients will receive tSMS of the left hemisphere and the other half of the right hemisphere.

NCT ID: NCT03778060 Not yet recruiting - Essential Tremor Clinical Trials

Long-Term Transcutaneous Stimulation and Essential Tremor: A PET Study

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Essential tremor (ET) is the most common movement disorder in the United States and affects up to 5% of the population. ET patients experience involuntary shaking of the hands, head and/or voice that can range from mildly limiting to severely disabling. Treatment options are limited and there are currently no medications specifically designed to treat it, and medications that are prescribed to relieve tremors are often limited by either inadequate efficacy or intolerable side effects. A subset of essential tremor patients whose tremors are inadequately treated by medication choose to undergo deep brain stimulation (DBS) of the ventral intermediate thalamic nucleus. DBS has been shown to be highly effective for tremor suppression. However, DBS carries significant risks. As a result, a very small (less than 3%) percentage of essential tremor patients undergo DBS therapy. The medical technology company Cala Health has developed a wristband device (the Cala TWO) that offers individuals with essential tremor a novel non-pharmacological, non-invasive alternative, in the form of stimulation of peripheral nerves, to aid in hand tremor relief. This innovative form of therapy has the potential to have important health, quality of life, and economic benefits for essential tremor patients. The present pilot study (Aim 1) will assess the effectiveness of 3-month twice daily treatment with the Cala TWO device to aid in the relief of hand tremors in adult essential tremor subjects that have been approved to undergo deep brain stimulation surgery at Mayo Clinic - Rochester. This study is a prospective, within subject, non-significant risk study at Mayo Clinic - Rochester, enrolling approximately 20 subjects. A completely optional component of this study (Aim 2) is seeking to perform three standard PET/CT sessions on a subset of these subjects (n=10) at Mayo Clinic - Rochester to evaluate changes in brain metabolic activity as a result of 3 months treatment with the device. The first session would take place upon a subjects entry into the study (start of month 1) and prior to any treatment with the Cala device, a second the following day after a 40 minute treatment period with the Cala device, and a third session at the end of the third month. This study is a prospective, within subject, greater than minimum risk study.

NCT ID: NCT03769961 Recruiting - Essential Tremor Clinical Trials

Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect

ATAX
Start date: December 1, 2018
Phase:
Study type: Observational

The proposed study aims to characterize ataxia occurring in essential tremor and essential tremor with DBS.

NCT ID: NCT03760406 Not yet recruiting - Essential Tremor Clinical Trials

Optimization of VIM Targeting in Essential Tremor Surgery

Opti-VIM
Start date: December 2018
Phase: N/A
Study type: Interventional

Deep 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.

NCT ID: NCT03696420 Recruiting - Essential Tremor Clinical Trials

Probabilistic Targeting of the VIM

PROBA-VIM
Start date: November 30, 2018
Phase:
Study type: Observational

After having included the most improved patients by DBS among those implanted in Bordeaux Hospital University, and having defined the most active plots on tremor by its prospective grading on Fahn-Tolosa-Marin (FTM) scale and accelerometry, coordinates of active plots and landmarks will be calculated on post-operative imaging. Association between landmarks and active plots coordinates will be modelled with machine-learning algorithms. The aim is to retrieve the position of the VIM on the basis of the landmarks coordinates.

NCT ID: NCT03688685 Not yet recruiting - Essential Tremor Clinical Trials

A Clinical Study to Evaluate CAD-1883 in Essential Tremor

Start date: December 2018
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: NCT03672266 Recruiting - Alzheimer Disease Clinical Trials

Studies of Brain and Body Interaction

Start date: August 1, 2018
Phase:
Study type: Observational

The goal of this study is to characterize biophysiolgoical signals as a comprehensive profile of the nervous systems in order to understand interactions between the brain and body, while an individual performs naturalistic behaviors (ex. walking, pointing) and while breathing at a slow controlled pace. The investigators aim to study these interactions among a variety of populations, from healthy individuals to those with disorders such as Autism Spectrum Disorder(s), including those who may also have an ADHD (Attention-deficit/hyperactivity disorder) diagnosis, Asperger's Syndrome, Alzheimer's Disease, and/or Fragile X syndrome

NCT ID: NCT03664609 Not yet recruiting - Parkinson Disease Clinical Trials

Deep Brain Stimulation (DBS) Retrospective Outcomes Study

Start date: February 1, 2019
Phase:
Study type: Observational

The 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.