Essential Tremor (ET) Clinical Trials
The purpose of this study is to evaluate the safety and initial effectiveness of MRgFUS thermal ablation of a designated area in the brain in patients suffering from medication-refractory Essential Tremor. The feasibility study conducted at University of Virginia is complete and is no longer recruiting patients.
Canada
Sunnybrook Medical Centre, Toronto in conjunction with University of Toronto
Principal Investigator: Michael Schwartz, MD, Neurosurgeon, Department of Surgery
Andres Lozano, MD, Department of Neurosurgery, University of Toronto
Clinical study coordinator Nir Lipsman, e-mail: nir.lipsman@utoronto.ca
Korea
Yonsei University College of Medicine
Principal Investigator: Jin Woo Chang, M.D, Ph.D., Professor & Chairman
Department of Neurosurgery, Director, Brain Research Institute
Clinical study coordination: Eun Jung Kweon, RN. MSN, Stereotactic & Functional Neurosurgery Coordinator
50 Yonseiro, Seodamungu, Seoul, 120-752, Korea
Tel: 82-2-2227-4578 (Mobile : 82-17-282-1044)
Fax: 82-2-393-9979
e-mail: kweonej@yuhs.ac
http://www.iseverance.com/
Japan
Shin-Yurigaoka General Hospital, Kanagawa, Japan
Principal Investigator: Dr. Takaomi Taira
Director of Stereotactic and Functional Neurosurgery
Tokyo Women’s Medical University
e-mail: ttaira@nij.twmu.ac.jp
Parkinson’s Disease Clinical Trials
This is a feasibility study is to develop data to evaluate the safety and initial effectiveness of unilateral focused ultrasound thalamotomy using this ExAblate Transcranial System in the treatment of medication-refractory tremor resulting from idiopathic Parkinson’s disease. This is a prospective, randomized, double-arm with sham procedure at a single site. See press clippings about this study
USA
University of Virginia
Principal Investigator: William Jeff Elias, MD
Study Coordinator: Joanna Loomba, e-mail: JJL4D@hscmail.mcc.virginia.edu
Tel: 434-243-1435 e-mail: fusbrain@virginia.edu
Movement Disorders Clinical Trials
The purpose of this study is to further investigate the precision and safety of ExAblate using MRgFUS for tissue ablation in the thalamus, subthalamus and pallidum, as well as collect initial clinical efficiency data for long-term chronic, therapy-resistant movement disorders patients, with Parkinson's disease or essential tremor.
Switzerland
The Center of Ultrasound Functional Neurosurgery, Solothurn, Switzerland
Principal Investigator: Prof. Dr. med. Daniel Jeanmonod
Tel: +41 32 621 79 32 e-mail: daniel.jeanmonod@sonimodul.ch
Neuropathic Pain Clinical Trials
The aim of this study is to assess the efficacy and the clinical safety of the ExAblate transcranial magnetic resonance guided high intensity focused ultrasound system for functional neurosurgery. The treatments to be conducted in this study are non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will be used to evaluate the basic safety aspects of this new treatment technology .
This is currently taking place at two sites in Switzerland :
- The Center of Ultrasound Functional Neurosurgery, Solothurn, Switzerland
Principal Investigator: Prof. Dr. med. Daniel Jeanmonod
Tel: +41 32 621 79 32 e-mail: daniel.jeanmonod@sonimodul.ch
- MR-Center, University Children's Hospital ,Zurich, Switzerland, CH-8032
Co-principal Investigator: Ernst Martin, MD
Tel: +41 44 266 7111 ext 7437 e-mail: ernst.martin@kispi.uzh.ch
Co-principal Investigator: Ronald Bauer, MD
Tel: +41 71 494 1111 + ext 3054 e-mail: ronald.bauer@kssg.ch
Sub-Investigator: Beat Werner, MSc
Brain Tumors Clinical Trials
The purpose of these studies is to evaluate the safety and feasibility of ExAblate Neuro using transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors. This is being conducted in Canada and Switzerland.
- Sunnybrook Health Science Centre, Toronto, Canada (ClinicalTrials.gov identifier: NCT01473485)
Principal Investigator: Todd Mainprize, MD
Study coordinator: Julie Gundry
Tel: 416-480-6100, ext 7362 e-mail: julie.gundry@sunnybrook.ca
- Zurich University Children's Hospital, Zurich, Switzerland (ClinicalTrials.gov Identifier: NCT01698437)
Co-principal investigator: Javier Fandino, MD and Ernst Martin, MD
e-mail: ernst.martin@kispi.uzh.ch
