View clinical trials related to Essential Tremor.
Filter by:The purpose of this Phase I open label study is to evaluate longer term tolerability and potential effectiveness of transcranial ultrasound in people with tremor as a results of Parkinson's Disease or Essential Tremor.
This is a 2-part clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of PRAX-114 in participants with essential tremor (ET). Part A is a randomized, double-blind, placebo-controlled, three-period, three-sequence, crossover design where participants will receive a single dose of 10 mg PRAX-114, 20 mg PRAX-114, and matching placebo. Part B is an open-label design where participants from Part A, after washout and confirmation of eligibility may elect to participate in Part B where all participants will receive 10 mg once every morning (QAM) for the first 14 days. Based on investigator judgement of the safety and tolerability, the dose for Days 15 to 28 could be increased to 20 mg QAM.
Research from our group has demonstrated modulation of PEFR in patients with STN and PAG stimulation. However, the effect of VIM (motor thalamus) stimulation remains to be investigated. Our group has also been involved in research that indicates that VIM stimulation may reduce perception of breathlessness. However, methodological factors limit the conclusions that can be drawn from this prior work. N-of-1 trials, organised as a randomised multiphase crossover design, are uniquely well suited for DBS research where stimulation can be switched ON and OFF, and with simple tests that can be done quickly, multiple times. PEFR and breath-holding are simple tests that we will test in this way. Other respiratory tests will be carried out along side, as optional, in a single phase design. We aim to offer this study to a continuous cohort of patients scheduled to undergo VIM (ET/DT) DBS at our institution. We will establish a pre-operative baseline of respiratory function, and then perform the n-of-1 trial post-operatively, soon after the patient returns to hospital to receive their DBS programming.
The primary purpose of this study is to evaluate the long-term safety and tolerability of SAGE-324 in participants with essential tremor (ET).
Essential tremor is a chronic and progressive neurological disease characterized by upper limb tremor. This is one of the most frequent movement disorders. Most of the time the disease worsens over the time, affecting patients' work abilities and in the most severe cases activities of daily living such as eating or dressing. For the most disabled patients, Deep brain stimulation (DBS) of the thalamic ventral intermediate median nucleus (Vim), a procedure consisting in an electrode implantation in a structure of the brain involved in tremor genesis, is the gold standard treatment. While this therapy is most of the time highly effective in alleviating the tremor, some subjects may exhibit gait impairment or upper limb coordination troubles years after the surgery, which are thought to be due to the involuntary stimulation of efferent cerebellar fiber tract. Unfortunately, this DBS induced side effect cannot be systematically avoided and may limit the possibilities of settings adaptation required to control the tremor. Surprisingly, while it could be a valuable therapeutic option for these patients suffering from DBS induced balance troubles, little is known about the effect of varying the rate of stimulation on the gait disorders associated with essential tremor and Vim DBS. The aim of or study is consequently to assess the effect of different frequency of stimulation on tremor, gait and balance disorders as well as on eye movements in patients uni or bilaterally stimulated in the Vim for a severe and medically intractable essential tremor. Patients followed at the National Hospital for Neurology and Neurosurgery (University College London Hospital) will be included. To better characterize the different symptoms, the investigators will use ataxia and tremor rating scale together with 3D gait motion analysis, oculography and computerized spiral test analysis. Our findings might lead to a better understanding of Vim-DBS associated gait disorders in essential tremor.
This research involves retrospective and prospective studies for clinical validation of a DystoniaNet deep learning platform for the diagnosis of isolated dystonia.
Individuals experiencing tremors face difficulty performing activities of daily living caused by involuntary oscillation of the muscles in the hands and arms. Current solutions to help suppress tremors include medication, surgery, assistive devices and lifestyle change. However, each of these has a drawback of its own including cost and unwanted side effects. Aside from the solutions listed, it has been shown that functional electrical stimulation(FES) is a possible solution to help suppress tremor. Additionally, FES can be combined with different technologies including accelerometers, gyroscopes and motion capture to develop a closed loop system for tremor suppression. However, this has drawbacks including signal interference and the need for multiple sensor to fully classify the tremor. Ultrasound imaging solves some of these issues because it can provide a direct visualization of hand muscles that contribute to tremor. This study will focus on detecting characterizing and differentiating tremors from voluntary hand motion using ultrasound imaging. The results obtained from this study will help design FES-based tremor-suppression techniques in the future. This study will target both subjects with different tremor disorders and able bodied subjects.
Essential tremor is one of the most common movement disorders in the world and is characterized by postural and/or kinetic tremor. Although the prevalence studies show differences due to the absence of a biological marker of the disease, it has been shown that the disease affects 4% of the population over 40 years of age and this rate may increase up to 14% in the population over 65 years of age. The annual incidence of Essential Tremor was found to be 616 per 100 thousand. The incidence of the disease increases with age. An incidence study shows that the disease increases progressively with age, with a sharp increase after age 49. In another study, it was stated that the age of onset of the disease showed a bimodal distribution, reaching the highest level in the second and sixth decades. It is stated that the severity and disability of tremor increase with age. The female-to-male ratio of the disease was found to be equal, but it was shown that more head tremor developed in females. Although the factors affecting essential tremor are aging, stress, family history, excessive caffeine consumption, smoking, muscle weakness, distal and proximal muscle strength differences were detected in young individuals with tremor. The aim of this study was to investigate the relationship between proximal and distal muscle strength and upper extremity functional skills in geriatric individuals with essential tremor.
This Pilot Phase 2A study will investigate the safety, tolerability, and pharmacokinetics (PK) of ES-481 in adult patients with essential tremor.
Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and/or kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and eating, and patients also experience associated social embarrassment. This study will assess how safe and effective BOTOX is in treating UL ET. Adverse events and change in disease activity will be evaluated. BOTOX is an investigational drug being developed for the treatment of UL ET. Participants are randomly assigned to 1 of the 4 groups, called treatment arms. Each group receives different treatment. There is 1 in 2 chance that participants will be assigned to placebo. Around 174 participants, aged 18 to 80 years with UL ET will be enrolled in approximately 40 sites in North America. Participants will receive BOTOX or placebo injections in Cycle 1 and Cycle 2. In Cycle 3, participants will receive unilateral or bilateral BOTOX injections. Each cycle is 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.