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

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ClinicalTrials.gov Identifier: NCT03100474
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
InSightec

Brief Summary:
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.

Condition or disease
Essential Tremor Parkinson's Disease Movement Disorders Neuropathic Pain

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 [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Global Registry: ExAblate 4000 Transcranial MR Guided Focused Ultrasound (TcMRgFUS) of Neurological Disorders:
Study Start Date : December 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Clinical Rating Scale for Tremor [ Time Frame: 5 year ]
    CRST



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patients suffering from clinically diagnosed neurologic disorders that can be
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100474


Contacts
Contact: Project Manager 1-214-630-2000

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Vyvian Ngo    650-498-0817    vyviann@stanfore.edu   
Principal Investigator: Pejman Ghanouni, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Charlene Aldrich, MSN         
Contact    410-328-5332    caldrich@som.umaryland.edu   
Principal Investigator: Howard Eisenberg, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Marie Kerr         
Contact    215-829-6720    kerrm@uphs.upenn.edu   
Principal Investigator: Gordon Baltuch, MD, PhD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Matthew Patterson    434-243-1435    fusbrain@virginia.edu   
Contact       fusbrain@virginia.edu   
Principal Investigator: Jeff Elias, MD         
United States, Washington
Swedish Neuroscience Institute Recruiting
Seattle, Washington, United States, 98122
Contact: Laura Johnson         
Contact    206-320-7115    laura.johnson@swedish.org   
Principal Investigator: Ryder Gwinn, MD         
Canada, Ontario
Sunnybrook Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Nadia Scantlebury         
Contact    416-480-4738    naida.scantlebury@sunnybrook.ca   
Principal Investigator: Michael Schwartz, MD         
Israel
Rambam Healthcare Campus Recruiting
Haifa, Israel
Contact: Alon Sinai, PhD         
Principal Investigator: Menashe Zaaroor, MD         
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Ayelet Brill         
Principal Investigator: Simon Israeli-Korn, MD         
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: Howard Eisenberg, MD University of Maryland

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03100474     History of Changes
Other Study ID Numbers: ND001
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by InSightec:
tremor
Parkinson's
movement
neuropathic
pain

Additional relevant MeSH terms:
Disease
Parkinson Disease
Neuralgia
Tremor
Movement Disorders
Essential Tremor
Nervous System Diseases
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Neurodegenerative Diseases
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Dyskinesias