Tremor

Researchers are investigating the long-term safety, tolerability, and effectiveness of a home-based peroneal electrical transcutaneous neuromodulation (eTNM4) treatment using the URIS I12 device in people with Parkinson's disease (PD) or Essential Tremor (ET). Earlier, a 6-week pilot study with 24 participants showed that this home treatment was safe, well tolerated, and had high adherence, with no treatment-related side effects. Although not designed to prove effectiveness, the pilot suggested improvements in tremor symptoms that lasted for weeks after treatment ended. This extension study aims to further evaluate these outcomes over a longer period. All participants will receive the peroneal eTNM treatment using the URIS I12 neurostimulator device. This device delivers electrical stimulation directly through the skin to the peroneal nerve. The study follows the same treatment procedure as previous studies but applies it over a longer timeframe to assess ongoing effects. This is an open-label, single-site study lasting 24 months, during which participants will continue home-based therapy under the study protocol. Participants will be monitored for safety and tolerability throughout the 24-month treatment period, with particular attention to any adverse events related to the therapy. Effectiveness will be assessed using patient self-reports and clinical scales measuring tremor severity and motor function. Researchers will also track participants' adherence and overall experience with the home treatment. The study aims to provide comprehensive data on the long-term impact of this non-invasive neuromodulation therapy on symptoms related to movement disorders in PD and ET.

Essential tremor (ET) is a common neurological disorder that can cause significant functional and psychological difficulties, often resistant to oral medications. Researchers are investigating a new approach called 3-D tractography Vim-Focused Ultrasound Ablation (Vim-FUSA), which uses advanced brain imaging to better target the area responsible for tremors. This study aims to compare this new method with the standard Vim-FUSA technique and evaluate its safety, feasibility, and effectiveness in both animal and human studies. The treatment involves using focused ultrasound guided by magnetic resonance (MR) imaging and 3-D tractography to precisely ablate 70% of the ventral intermediate nucleus (Vim) in the brain. The procedure includes head preparation, placement of a stereotactic frame, pre-surgery imaging, exploration with low-dose sonications, and therapeutic sonications to deliver the ablation while monitoring tremor and side effects. The study includes an experimental animal phase comparing the new and standard methods and a human phase assessing 24 participants before treatment and three months after. Participants will undergo assessments including videotaped tremor evaluations at baseline and three months post-treatment, with blinded comparison to matched controls. Researchers will use intraoperative MR imaging to distinguish treated tissue from swelling and predict clinical outcomes. Safety, side effects, quality of life related to tremor, and participant satisfaction will also be monitored. Overall participation lasts at least three months, with careful follow-up to evaluate treatment effects and safety.

Researchers are evaluating the use of Abobotulinum toxin A (Dysport) in adults aged 18 to 80 years who have task-dependent essential tremor affecting the upper limb. This pilot study aims to refine ways to measure improvements in motor skills and disability using video analysis, and to assess the effects and tolerability of Dysport injections. The study also seeks to gather data that will help design a larger future clinical trial. The study uses a randomized, double-blind, placebo-controlled, crossover design where participants receive Dysport injections and placebo injections during different periods. The dose of Dysport is adjusted at each visit based on the muscles involved. Participants perform specific functional tasks to assess tremor severity, including pointing, pouring, feeding, string instrument playing, or computer mouse use. Participants will be monitored through patient and physician impressions of change at 6 and 18 weeks after injections. The study tracks motor performance and disability improvements via blinded video analysis. Safety and tolerability of the injections are also evaluated. The total duration includes multiple visits to assess the effects of both Dysport and placebo treatments.

Researchers are collecting long-term safety and effectiveness data of unilateral thalamotomy using the Exablate Neuro system for people with medication-refractory tremor dominant Parkinson's Disease (TDPD). This observational post-approval registry is required following the approval of the Exablate Model 4000 Type 1.0 and 1.1 devices. The study focuses on patients who have already received this focused ultrasound treatment for tremor associated with TDPD. Participants have undergone unilateral thalamotomy targeting the ventralis medius region using the commercially available Exablate Neuro device. No new interventions are performed during this registry. Data collection includes monitoring medication use and various assessments over time to understand the treatment's long-term impact. Participants are followed with assessments at baseline, 1, 3, 6, and 12 months after their procedure, then annually for up to five years. Researchers collect information on adverse events, clinical tremor ratings on medication, Parkinson's motor function, quality of life, and work productivity. The primary outcome is the evaluation of long-term adverse events over five years, alongside measuring tremor and motor symptom impact on disability.

Researchers are evaluating the long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems used for various movement disorders, including Parkinson's disease, essential tremor, disabling tremor, and dystonia. This international, prospective, multicenter study collects data from patients implanted with Abbott DBS devices during routine clinical care to understand outcomes over time. Participants implanted with the Abbott DBS system will be observed without altering their treatment, as this is an observational study. The study follows subjects for five years from their initial programming visit to gather information on device performance and patient motor function over time. During the study, participants will have regular assessments using disease-specific motor rating scales such as MDS-UPDRS Part III for Parkinson's disease and FTM-TRS for tremor. Researchers will monitor changes in motor symptoms and record any serious device- or procedure-related adverse events. Study involvement lasts for five years, allowing long-term collection of safety and effectiveness data.

Researchers are studying an approach to improve programming of deep brain stimulation (DBS) systems for people with essential tremor (ET), a condition causing postural and action tremors. This study focuses on using subject-specific computational models to predict brain pathways activated by DBS targeting the ventralis intermedius nucleus (Vim) of the thalamus. The goal is to help clinicians find the most effective stimulation settings more efficiently than the current laborious process. Participants already implanted with a DBS lead in the Vim as part of their routine care will be involved. The study will use advanced brain imaging techniques like 7-Tesla MRI and diffusion tensor imaging to build personalized neuron models. These models will guide a computational algorithm to identify optimal stimulation settings within FDA-approved safety limits. Settings will be tested during follow-up visits every six months for up to two years, comparing different target areas within the motor thalamus to find the most effective tremor suppression. During the study, participants will attend routine clinical follow-up sessions where clinicians will evaluate the effects of the DBS settings using the Essential Tremor Rating Assessment Scale (TETRAS) and quality of life questionnaires. Outcome measures include therapeutic window size, objective tremor assessments, and quality of life at 24 months. Researchers will monitor safety and treatment effectiveness throughout, ensuring stimulation remains within approved limits while assessing improvements in tremor control and participant well-being.

Researchers are evaluating the long-term outcomes of MR-guided focused ultrasound (MRgFUS) thalamotomy in patients with essential tremor that does not respond to medication. This observational study aims to find out if MRgFUS thalamotomy provides sustained tremor reduction over three years and to assess the neurological and quality-of-life effects of this procedure. Approximately 240 participants will be followed at a single center over about six years. Participants will undergo MRgFUS thalamotomy as part of their standard care at Sunnybrook Health Sciences Centre. After treatment, they will be monitored prospectively for at least three years. Scheduled assessments include clinical rating scales for tremor and ataxia, neurological exams, adverse event monitoring, quality-of-life questionnaires, MRI scans, and neuropsychological testing at multiple time points from baseline through three years post-treatment. Participants will have visits at baseline, Day 1, Week 12, and annually at 1, 2, and 3 years after treatment. During these visits, researchers will evaluate changes in tremor severity using the Clinical Rating Scale for Tremor and assess neurological status, quality of life, ataxia symptoms, and MRI changes. Safety and adverse events will also be closely monitored throughout the follow-up period, ensuring comprehensive long-term data collection on the procedure’s effects.

Essential tremor (ET) affects over 6 million Americans and about 5% of adults over age 60. People with ET have a significantly higher chance of developing Parkinson's disease (PD) compared to others their age, with about 1% developing PD each year. Some ET patients show Lewy body pathology after death, indicating that a portion may be in early stages of PD. Current screening tests for early PD are either not sensitive enough, costly, or invasive. This study looks at the Syn-One Test, which uses a small skin biopsy to detect phosphorylated alpha-synuclein (P-SYN), a marker linked to PD. Participants diagnosed with ET or ET-Plus will be observed to find out if they have P-SYN in their skin and to predict who may develop PD over time. The study includes adults aged 50 to 85 years and follows them from the start for up to 24 months. Participants will be divided into groups based on their diagnosis of ET or ET-Plus. During the study, researchers will measure the amount of P-SYN in skin samples at the start, at 12 months, and again at 24 months. They will also track if and when participants develop PD symptoms. Participants must complete all study procedures and give informed consent. Safety factors like wound healing and anesthesia allergies are considered to protect participants.

Researchers are investigating how deep brain stimulation (DBS) affects attention, perception, and cognition in people with Parkinson's disease (PD) and other movement disorders like essential tremor (ET) and dystonia (DT). The study aims to understand if attention problems in PD change how social cues are interpreted and whether DBS improves or worsens these difficulties. It also explores how DBS might be optimized to restore attention control while treating other symptoms and what brain areas targeted by DBS contribute to attention control. Participants are grouped into those with PD, ET, or DT undergoing DBS, and healthy controls without these disorders. The study includes tasks where participants view and rate facial expressions while their eye movements are tracked. DBS stimulation is altered acutely during the study in three randomized conditions: normal therapeutic DBS, reduced current DBS, and reduced frequency DBS, each lasting about 20 minutes. Evaluations occur before DBS implantation, during awake DBS surgery, and after DBS initiation with changes in stimulation. Participants will be involved in facial emotion rating tasks and visual search tasks while eye tracking and brain activity recordings are performed. Assessments include facial expression ratings and eye tracking at baseline, intraoperative microrecordings during surgery, and follow-up after DBS optimization. Additional measures include EEG and local field potential recordings during emotional face viewing to study brain activity related to attention and perception. The study continues through approximately six months after DBS implantation, with thorough monitoring of cognitive and perceptual outcomes.

Researchers are evaluating the use of Gamma Knife thalamotomy for patients with essential tremor who have already undergone successful treatment on one side of the brain. This combined Phase II/III multicenter trial aims to study the effects and safety of treating the opposite side to improve quality of life. The trial will assess changes in tremor impact and patient health over time, with particular focus on side effects and functional outcomes. Participants will receive a contralateral thalamotomy using a frame-based Gamma Knife Perfexion or Icon system. The initial Phase II portion involves 10 patients, with plans to expand to Phase III by enrolling 40 more after safety review. Treatments target the VIM nucleus of the thalamus, and patients will be monitored at multiple intervals including 3, 6, 12, 24, and 36 months after the procedure. During the study, participants will undergo evaluations of tremor severity, gait, speech, and quality of life through filmed assessments and questionnaires. Safety monitoring includes grading side effects per established criteria. The primary outcomes focus on changes in quality of life (QUEST score) and patient-reported health utility at 12 months. Secondary outcomes include objective measures of tremor, gait, speech, adverse events, and long-term follow-up to 36 months after treatment.