Bilateral Treatment of Medication Refractory Essential Tremor

Essential Tremor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04112381
• Other study ID #: ET005
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Country where clinical trial is conducted

United States, 

Outcome

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