University of Maryland, Baltimore

Bilateral Treatment of Medication Refractory Essential Tremor

Purpose

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.

Condition

Essential Tremor

Eligibility

Eligible Ages: Over 22 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Exablate Secondary Procedure	Thalamotomy	Device: Exablate Model 4000 Type 1.0/1.1 Exablate thalamotomy of non tremor dominant side of the brain

More Details

Status: Active, not recruiting
Sponsor: InSightec

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.