Bilateral Treatment of Medication Refractory Essential Tremor

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04112381

Enrollment

Registered

2019-10-02

Start date

2020-06-30

Completion date

2026-06-30

Last updated

2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Tremor

Brief summary

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.

Interventions

DEVICEExablate Model 4000 Type 1.0/1.1

Exablate thalamotomy of non tremor dominant side of the brain

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Men and women age 22 years or older 2. Diagnosis of medication-refractory Essential Tremor 3. 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 4. Able to communicate sensations during the Exablate thalamotomy procedure

Exclusion criteria

1. Has experienced any non-transient neurological event or worsening following the Exablate index procedure 2. Presence of unknown or MR unsafe devices anywhere in the body 3. Non-transient hemiparesis as determined by physical examination 4. Clinically significant abnormal speech function as determined by a speech pathologist 5. Pregnant or breastfeeding 6. Unstable cardiac status 7. Behavior(s) consistent with ethanol or substance abuse 8. History of bleeding disorder 9. Has received anticoagulants within one month of Exablate procedure 10. Cerebrovascular disease 11. Intracranial tumor 12. Active or suspected acute or chronic uncontrolled infection 13. Has previously had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus 14. Implanted objects in the skull or the brain 15. 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 16. Unable to communicate with the investigator and staff

Design outcomes

Primary

Measure	Time frame	Description
Device and procedure related adverse events	3 months	rate of adverse events following the Exablate secondary procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026