Dual-site transcranial magnetic stimulation targeting the supplementary motor area and cerebellum for essential tremor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled phase II trial at the University of São Paulo compares active versus sham dual-site repetitive transcranial magnetic stimulation (rTMS) in medication-refractory essential tremor. Participants receive five consecutive daily sessions of sequential low-frequency rTMS to the supplementary motor area (1 Hz, 110% resting motor threshold) followed by high-frequency stimulation to the cerebellar cortex (10 Hz, 90% resting motor threshold) or matched sham. Clinical tremor ratings and neurophysiological measures are collected at baseline, immediately after the stimulation course, and during follow-up to track effects and safety. The protocol is based on neuroimaging/neurophysiology supporting a network model of tremor and pilot data showing clinically meaningful tremor reduction with combined stimulation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sao Paulo University
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Ananda Carolina Moraes de Falcone, Md
• Email: ananda.falcone@gmail.com
• Phone: +5516981768412

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Low Intensity Focused Ultrasound for Essential Tremor in Adults

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• Closed-loop TMS to reduce tremor

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.