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ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

NCT01772693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-10-09

Study results available
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Summary

This is a feasibility study to evaluate the safety and initial effectiveness of unilateral ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system compared to a Sham Vim thalamotomy procedure.

Data will be collected to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. The Sham treatment data will be used to evaluate placebo effect from treatment.

Conditions

Interventions

DEVICE

ExAblate Transcranial MRgFUS

ExAblate Transcranial MR Guided Focused Ultrasound

DEVICE

Sham ExAblate Transcranial MRgFUS

Sham ExAblate Transcranial MR Guided Focused Ultrasound

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • Jeff Elias, M.D. · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-04-26
Completion
2019-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01772693 on ClinicalTrials.gov