Dual-site transcranial magnetic stimulation targeting the supplementary motor area and cerebellum for essential tremor
Dual-Site Transcranial Magnetic Stimulation of the Supplementary Motor Area and Cerebellum for the Treatment of Essential Tremor
This trial will test whether five days of combined transcranial magnetic stimulation over the supplementary motor area and cerebellum can reduce tremor in adults whose essential tremor did not improve with standard medications.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | São Paulo State University Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07344194 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–80 with essential tremor that remains disabling despite optimized propranolol and primidone therapy who can provide informed consent are ideal candidates.
Not a fit: Patients whose tremor is well controlled by medications, those with contraindications to TMS (for example a history of epilepsy or certain metallic implants), or those with other causes of tremor are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could meaningfully reduce tremor and improve daily functioning for patients with medication-refractory essential tremor.
How similar studies have performed: Single-site rTMS studies have been inconsistent, but prior pilot work combining SMA and cerebellar stimulation reported clinically meaningful tremor reductions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo, São Paulo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.