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New treatment option for Essential Tremor
Official title Dual-Site Transcranial Magnetic Stimulation of the Supplementary Motor Area and Cerebellum for the Treatment of Essential Tremor.
ClinicalTrials.gov ID: NCT07344194
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Medication-refractory tremor, defined as prior use of both first-line medications (propranolol and primidone) at maximally tolerated doses without...
- 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.
You likely can't join if
- 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...
- Concomitant participation in another investigational drug or device study.
- Pregnancy or breastfeeding.
- Presence of an implanted deep brain stimulation (DBS) system.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.