Essential 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 developing a multicenter registry to collect and share data on pediatric patients who have undergone deep brain stimulation (DBS) for movement disorders such as dystonia, epilepsy, Tourette syndrome, and mood disorders. The study aims to improve understanding of DBS safety and effectiveness in children, as current data are limited and individual centers often have too few cases for strong research. This registry will support large-scale analyses and help refine DBS as a treatment option for hyperkinetic movement disorders in the pediatric population. The study involves gathering both retrospective and prospective clinical data from multiple pediatric centers. The registry will collect information on surgical techniques, patient outcomes, implant sites, and long-term effects of DBS. This collaborative data-sharing approach enables comprehensive evaluation of which patients benefit most from DBS and how it impacts their quality of life over time. Participants include children aged 0 to 18 years who have already received or are scheduled to receive DBS for neurological movement disorders. Data will be collected over five years to monitor safety, efficacy, and quality of life outcomes. The study does not involve treatment administration but focuses on gathering and analyzing clinical information. Parental or legal guardian consent is required for prospective participation.

Researchers are monitoring people with advanced idiopathic Parkinson's Disease who have moderate to severe motor symptoms that do not respond well to medication. This study is an international, observational registry following patients who have undergone a unilateral pallidotomy using the Exablate Neuro device. The goal is to collect long-term information about this treatment after its approval. The treatment involves a focused ultrasound procedure called unilateral pallidotomy performed with the Exablate Model 4000 system. This registry will observe patients who have already received this procedure as part of their standard care. No additional treatment is given as part of the study. Patients will be followed with visits at 3, 6, and 12 months after the procedure, and then annually for up to 5 years. During the follow-up visits, researchers will collect information including any side effects, medication use, motor function scores, dyskinesia severity, quality of life, work productivity, and overall impressions from both doctors and patients. Safety and effectiveness will be assessed mainly by tracking responder outcomes over five years. Participants will be closely monitored throughout the study period, which may last up to five years from the time of the procedure.

Researchers are investigating epilepsy-dyskinesia syndromes, which are rare genetic diseases causing both movement disorders and epilepsy in children. This multinational retrospective survey, supported by the International Parkinson and Movement Disorder Society, aims to collect detailed clinical and molecular data to better understand these conditions. The study focuses on identifying patterns in disease features, progression, and genetic links to improve knowledge and support precision medicine. The study collects previously recorded data from multiple countries, harmonizing information on clinical features, disease progression, age of onset, genetic variants, and coexisting neurological conditions. By standardizing this data, the survey addresses challenges in rare disease research like small, dispersed patient groups and inconsistent protocols. The goal is to build a shared clinical database and analyze how movement and seizure disorders relate at both clinical and molecular levels. Participants are children aged 0 to 18 years with diagnosed movement disorders linked to specific genetic variants. The study reviews existing medical records and genetic information without new treatments or interventions. Researchers will assess the disease spectrum, how movement disorders affect quality of life, and the effectiveness of symptomatic treatments over one year. The study encourages international collaboration to advance understanding and improve care for these rare conditions.

Researchers are evaluating the long-term safety of buntanetap in people with Parkinson's Disease (PD) through a 36-month open-label safety study. The trial includes two groups: one with participants previously involved in buntanetap trials and another with participants receiving deep brain stimulation (DBS) treatment. This study focuses on safety, monitoring side effects and adverse events during the treatment period. Participants will receive a daily oral dose of buntanetap 30 mg after a screening period of up to 42 days. Cohort 1 participants stop their usual Parkinson's medications 12 hours before baseline and annual visits to ensure an OFF state during assessments. Cohort 2 participants, who have had DBS surgery, will also stop standard medications 12 hours before visits and reset their DBS settings to baseline the night before key visits. Throughout the study, participants will undergo assessments including cognitive and motor function tests such as MMSE, MoCA, C-SSRS, and MDS-UPDRS by trained clinicians. They will be monitored for adverse events, treatment safety, and treatment-emergent side effects over the 36 months. Participants must have a support person for visits, and safety will be closely observed to ensure well-being during the trial.

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 comparing two types of deep brain stimulation (DBS) treatments, adaptive DBS (aDBS) and continuous DBS (cDBS), in people with Parkinson's disease. The main goal is to see if aDBS increases the daily average time patients spend in an ON state without troublesome involuntary movements more than cDBS over six months. This study involves patients who already have Medtronic Percept DBS electrodes implanted targeting specific brain areas. Participants will first have their devices set to continuous DBS during an initial programming visit. Two weeks later, they will be randomly assigned to either continue with cDBS or switch to aDBS, where the device adapts stimulation based on brain signals. The study follows participants for six months, with check-ins at three and six months. Throughout the study, participants will complete Parkinson's disease home diaries at several time points to track symptoms. During the study, researchers will monitor changes using the home diary from baseline through six months. Other assessments include motor function scales (MDS-UPDRS III and IV), cognitive tests, mood and sleep questionnaires, medication use, and brain signal measurements. Safety and side effects will also be tracked. Participants will be evaluated on treatment burden and satisfaction after six months. Overall participation lasts about six months after device programming.

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.