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Active, Not Recruiting

NCT Number: NCT04112381

Bilateral Treatment of Medication Refractory Essential Tremor

The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, School of Medicine, Stanford, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women age 22 years or older
  • Diagnosis of medication-refractory Essential Tremor
  • Has previously underwent an Exablate index procedure in a clinical trial or in a commercial setting at least 9 months prior to enrolling in this trial
  • Able to communicate sensations during the Exablate thalamotomy procedure

Exclusion criteria

  • Has experienced any non-transient neurological event or worsening following the Exablate index procedure
  • Presence of unknown or MR unsafe devices anywhere in the body
  • Non-transient hemiparesis as determined by physical examination
  • Clinically significant abnormal speech function as determined by a speech pathologist
  • Pregnant or breastfeeding
  • Unstable cardiac status
  • Behavior(s) consistent with ethanol or substance abuse
  • History of bleeding disorder
  • Has received anticoagulants within one month of Exablate procedure
  • Cerebrovascular disease
  • Intracranial tumor
  • Active or suspected acute or chronic uncontrolled infection
  • Has previously had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus
  • Implanted objects in the skull or the brain
  • Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
  • Unable to communicate with the investigator and staff

Treatment and study plan

Exablate Model 4000 Type 1.0/1.1

Device

Exablate thalamotomy of non tremor dominant side of the brain

Primary outcomes

  1. Device and procedure related adverse events

    Time frame: 3 months

    rate of adverse events following the Exablate secondary procedure

Sponsors and collaborators

Lead sponsor

InSightec

Industry

Registry information

Official study title

A Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2019
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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