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Clinical Trials in the USA / NCT04112381
Active, not recruiting Not applicable

Bilateral Treatment of Medication Refractory Essential Tremor

NCT04112381 · tracked via the Priya Life Science USA tracker
Sponsor
InSightec
Phase
Not applicable
Started
2020-06-30
Last updated
2025-05-01

Condition(s) studied

Essential Tremor

Investigational drug(s) / intervention(s)

Exablate Model 4000 Type 1.0/1.1

Exablate Model 4000 Type 1.0/1.1: Exablate thalamotomy of non tremor dominant side of the brain

Study 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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Stanford University, School of Medicine Stanford California
University of Maryland Baltimore Maryland
Weill Cornell Medicine New York New York
The Ohio State University - Wexner Medical Center Columbus Ohio
University of Pennsylvania Philadelphia Pennsylvania
University of Virginia Charlottesville Virginia
West Virginia University Morgantown West Virginia

More InSightec trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04112381 on ClinicalTrials.gov ↗ ← All trials in the USA