NCT07344194 Dual-Site Transcranial Magnetic Stimulation of the Supplementary Motor Area and Cerebellum for the Treatment of Essential Tremor.
| NCT ID | NCT07344194 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | São Paulo State University |
| Condition | Essential Tremor |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2026-01-15 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 of these two brain regions. Participants will receive five sessions of rTMS, consisting of low-frequency stimulation over the SMA followed by high-frequency stimulation over the cerebellum. The main hypothesis is that this combined approach will lead to an immediate and sustained improvement in action tremor of the dominant upper limb, measured up to four weeks after treatment. Secondary outcomes include quality of life, safety, side effects, and changes in brain excitability associated with tremor improvement.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07344194 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Essential Tremor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07344194 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07344194 currently recruiting?
Yes, NCT07344194 is actively recruiting participants. Contact the research team at ananda.falcone@gmail.com for enrollment information.
Where is the NCT07344194 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07344194 clinical trial?
NCT07344194 is sponsored by São Paulo State University. The trial plans to enroll 36 participants.