NCT04112381

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

5.7 years

First QC Date

September 30, 2019

Last Update Submit

April 30, 2025

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

  • Device and procedure related adverse events

    rate of adverse events following the Exablate secondary procedure

    3 months

Study Arms (1)

Exablate Secondary Procedure

EXPERIMENTAL

Thalamotomy

Device: Exablate Model 4000 Type 1.0/1.1

Interventions

Exablate Model 4000 Type 1.0/1.1DEVICE

Exablate thalamotomy of non tremor dominant side of the brain

Exablate Secondary Procedure

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

The Ohio State University - Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

West Virginia University

Morgantown, West Virginia, 26505, United States

Location

Related Publications (1)

  • Kaplitt MG, Krishna V, Eisenberg HM, Elias WJ, Ghanouni P, Baltuch GH, Rezai A, Halpern CH, Dalm B, Fishman PS, Buch VP, Moosa S, Sarva H, Murray AM. Safety and Efficacy of Staged, Bilateral Focused Ultrasound Thalamotomy in Essential Tremor: An Open-Label Clinical Trial. JAMA Neurol. 2024 Sep 1;81(9):939-946. doi: 10.1001/jamaneurol.2024.2295.

    PMID: 39073822DERIVED

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 2, 2019

Study Start

June 30, 2020

Primary Completion

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(7)