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Dual-Site Transcranial Magnetic Stimulation of the Supplementary Motor Area and Cerebellum for the Treatment of Essential Tremor.

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllSรฃo Paulo State University
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In plain words

What the trial is, and whether it could suit you

Essential tremor is a common movement disorder that causes involuntary shaking, mainly during voluntary actions such as writing or holding objects. Recent research suggests that essential tremor is not caused by a single brain area, but by abnormal activity within a network that includes the cerebellum and motor areas of the brain. However, most non-invasive brain stimulation studies to date have targeted only one brain region and have shown inconsistent clinical benefits. This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effects of a dual-site transcranial magnetic stimulation (rTMS) protocol targeting the supplementary motor area (SMA) and the cerebellum in patients with essential tremor that does not respond adequately to standard medications. The study is based on previous pilot data showing meaningful tremor reduction using combined stimulation o

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or female participants, aged 18 to 80 years; women of childbearing potential must not be pregnant. * Diagnosis of Essential Tremor with a score greater than 2 on items 5 or 6 of the Fahn-Tolosa-Marin Tremor Rating Scale despite optimized medical therapy. * Medication-refractory tremor, defined as prior use of both first-line medications (propranolol and primidone) at maximally tolerated doses without adequate tremor control. * Ability to provide written informed consent in accordance with institutional policies. * Ability to comply with all study procedures and follow-up assessments as defined by the study protocol. Exclusion Criteria: * Unstable or untreated psychiatric disorders. * Inability to provide informed consent. * Uncontrolled medical conditions, including but not limited to uncontrolled diabetes mellitus, hypertension, symptomatic pulmonary disease, or symptomatic cardiac disease. * Concomitant participation in another investigational drug or device study. * Pregnancy or breastfeeding. * Presence of an implanted deep brain stimulation (DBS) system. * History of epilepsy not adequately controlled, defined as seizure-free for less than 5 years. * Presence of a cardiac pacemaker. * Presence of metallic implants in any part of the body that are contraindicated for rTMS.
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What it tests

  • Dual-site repetitive transcranial magnetic stimulation (rTMS) of the supplementary motor area and cerebellum
  • Transcranial Magnetic Stimulation Sham
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Where

1 site
Sao Paulo University
Sรฃo Paulo, Brazil
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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