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ACTIVE NOT RECRUITING
NCT03319485
NA

ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease

Sponsor: InSightec

View on ClinicalTrials.gov

Summary

Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.

Official title: A Pivotal Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Neuro System

Key Details

Gender

All

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2018-02-09

Completion Date

2026-08-31

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DEVICE

ExAblate Pallidotomy

ExAblate Pallidotomy for Parkinson's Disease

DEVICE

Sham ExAblate Pallidotomy

ExAblate MRgFUS Sham Procedure

Locations (20)

Stanford University Medical Center

Stanford, California, United States

Palm Beach Neuroscience Institute/Sperling Medical Group

Boynton Beach, Florida, United States

University of Maryland Medical System

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

New York University Health Langone

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

The Ohio State Wexner Medical Center

Columbus, Ohio, United States

Pennsylvania Hospital Department of Neurosurgery

Philadelphia, Pennsylvania, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

Toronto Western Hospital

Toronto, Ontario, Canada

Rambam Health Care

Haifa, Israel

Fondazione IRCCS Neurological Institute Carlo Besta

Milan, Italy

Azienda Ospedaliera Universitaria di Verona, Univerista di Verona

Verona, Italy

Severance Hospital, Yonsei University Health System

Seoul, South Korea

CINAC-Hospital HM Puerta del Sur

Móstoles, Madrid, Spain

Clinica Universidad De Navarra

Pamplona, Navarre, Spain

Chang Bing Show Chwan Memorial Hospital

Changhua, Taiwan

St. Mary's Hospital

London, United Kingdom