Ultrasound as treatment: update

Hello,

You are receiving this email because you are enrolled in Dr. Jeffrey Elias’ Focused Ultrasound Database for Patients with Movement Disorders (IRB#16034). We are pleased to announce that the clinical trial entitled “IRB-HSR# 16828: A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects” has met the goal for enrollment. This means that no new patients will be enrolled at UVA or the other trial sites.

Research involving previously enrolled subjects is ongoing and we will continue to collect data over the next year. The study sponsor, Insightec will be submitting preliminary data to the FDA this year.

It is our hope that the FDA will approve this technology for the treatment of Essential Tremor. If any additional Essential Tremor trials open at UVA or we have any opportunity to offer this investigational procedure, we will contact patients that have registered in the database to come to UVA for consideration. If you are receiving this update, you will automatically receive future updates from us (unless you contact us requesting you be removed from our database IRB16034).

Thank you for your interest in this research. We regret that access is limited at this time, but the research process is necessary for FDA approval. We ask that you do not reply or call in response to this email so that we can focus our efforts on our ongoing research. If you are receiving this email you are already in the UVA pool of applicants for focused ultrasound trials for movement disorders. You will be sent an email should we have other results to report, or when trials open or close to enrollment that are relevant to your reported diagnosis.

UVA Focused Ultrasound trials open to enrollment:

Parkinson’s Disease: PD001 (A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease IRB#16203)

We will continue contacting subjects for screening according to established processes.

For information on focused ultrasound research at other institutions please refer to the following websites:

insightec.com/

clinicaltrials.gov

fusfoundation.org/

Sincerely,

Amy Warren, MS

Clinical Research Coordinator

University of Virginia Department of Neurosurgery

[arthur84]

I am not a candidate for this research. Arthur 84

[Hikoi]

Roy

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