Essential Tremor Clinical Trial
Official title:
A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Essential Tremor
A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial
MRI-guided focused ultrasound (MRgFUS) treatment of patients with medication-refractory
movement disorders, namely Essential Tremor (ET).
This study is designed as a prospective, single site, single arm, nonrandomized study.
Assessments will be made before and three months after MRgFUS for clinical symptom relief,
quality of life (QoL) improvements, and safety of MRgFUS in the treatment of ET. Similarly,
QoL measures will be obtained using Quality of Life in Essential Tremor (QUEST)
questionnaire. Relative Safety will be evaluated using a common description of Significant
Clinical Complications for patients treated in this study. This study will be performed on
the 3T MR scanners.
The ExAblate system is a medical device that involves a focused ultrasound system and an MRI
scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the
targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion
created in the ventralis intermedius nucleus of the thalamus.
The treatment begins with a series of standard diagnostic MR images to identify the location
and shape of tumor to be treated. The ExAblate computer uses the physician's designation of
the target volume to plan the best way to cover the target volume with small spots called
"sonications". These treatment spots are cylinder shaped. Their size depends on sonication
power and duration. During the treatment, a specific MR scan, which can be processed to
identify changes in tissue temperature, provides a thermal map of the treatment volume to
confirm the therapeutic effect. The thermal map is used to monitor the treatment in
progress, and confirm that the ablation is proceeding according to plan, thus closing the
therapy loop.
The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing
1000-element phased array transducer) positioned above the subject head. The ExAblate
transcranial system also includes means to immobilize the subject head, cool the interface
water, and software for CT analysis and phase correction computation.
The ExAblate transcranial system is an experimental device and is being investigated in this
study.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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