Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:

April 19, 2023 updated by: InSightec

Global Registry: ExAblate 4000 Transcranial MR Guided Focused Ultrasound (TcMRgFUS) of Neurological Disorders:

A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

A global, multi-center, open-label, observational registry to capture safety and effectiveness data related to ExAblate Neuro, an MRI guided focused ultrasound device designed to lesion tissue deep within the brain using sound waves without the need for craniotomy. This registry includes certain regional and country specific approved thalamotomy and pallidotomy procedures using ExAblate Neuro for the treatment of various neurologic disorders such as essential tremor, Parkinson's movement disorders, and neuropathic pain. Treatment targets/indications are country/region dependent based on approved labeling within that region.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook
  • Israel
      • Haifa, Israel
        • Rambam Healthcare Campus
      • Ramat Gan, Israel
        • Sheba Medical Center
  • Taiwan
      • Chang Hua, Taiwan, 505
        • Chang Bing Show Chwan Memorial Hospital
  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • University of Pennsylvania
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Neuroscience Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any patients suffering from clinically diagnosed neurologic disorders that can be

Description

Inclusion Criteria:

  • Meets labeling indication for use per information for prescribers
  • Target is accessible by Focused Ultrasound per treatment planning parameters

Exclusion Criteria:

  • Do not agree to participate or who are unlikely to participate over an extended period of time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Rating Scale for Tremor
Time Frame: 5 year
CRST
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSightec

Investigators

  • Principal Investigator: Howard Eisenberg, MD, University of Maryland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 3, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ND001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be shared via request from the publication committee. Active site participants will have access; however, it has not been decided when or if data will be shared with researchers not participating on this registry.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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