Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

NCT ID: NCT02289560

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2023-03-10

Brief Summary

The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET).

Detailed Description

This study is evaluating a new technique for performing Thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate if totally non-invasive and without any radiation. After informed consent and screening, eligible subjects will be undergo an ExAblate treatment. All subjects will be followed at 1 day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.

Conditions

Essential Tremor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcranial ExAblate

Transcranial ExAblate

Group Type: EXPERIMENTAL

Transcranial ExAblate

Intervention Type: DEVICE

Transcranial ExAblate

Interventions

Transcranial ExAblate

Transcranial ExAblate

Intervention Type: DEVICE

Other Intervention Names

ExAblate; TcMRgFUS; Thalamotomy

Eligibility Criteria

Inclusion Criteria

• Men and women, age 22 years and older
• Subjects who are able and willing to give informed consent and able to attend all study visits
• Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
• Subject exhibits a significant disability from their ET despite medical treatment
• Subjects should be on a stable dose of all ET medications for 30 days prior to study entry
• Subject is able to communicate sensations during the ExAblate Transcranial procedure

Exclusion Criteria

• Subjects with unstable cardiac status
• Severe hypertension
• Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
• Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
• Significant claustrophobia that cannot be managed with mild medication
• Current medical condition resulting in abnormal bleeding and/or coagulopathy
• Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
• History of intracranial hemorrhage
• History of multiple strokes, or a stroke within past 6 months
• Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
• Are participating or have participated in another clinical trial in the last 30 days
• Subjects unable to communicate with the investigator and staff
• Subjects with a history of seizures within the past year
• Subjects with brain tumors

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InSightec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University Medical Center

Stanford, California, United States

University of Maryland Medical System

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

The Ohio State Wexner Medical Center

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Virginia

Charlottesville, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Study Documents

Document Type: Clinical Study Report

View Document

Other Identifiers

ET002CA

Identifier Type: -

Identifier Source: org_study_id