A Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
The objective of this prospective, multi-site, single-arm, open-label study is to capture the safety and efficacy (outcome) of bilateral staged Exablate treatment in subjects with bilateral medication-refractory essential tremor (ET). The staged second procedure will be performed at least 9 months after the first side. The benefit of real-time feedback will allow the physician to maximize benefit without jeopardizing safety. This study is designed as a prospective, open-label, single arm, multi-site study design.
• Subjects who:
∙ previously underwent Exablate thalamotomy for their essential tremor in a clinical study or in a commercial procedure at least 9 months prior to enrolling in this study for contralateral Exablate thalamotomy
‣ Subjects who would benefit from a bilateral treatment for their essential tremor and would want to undergo a staged bilateral thalamotomy
• All subjects must have a complete baseline CRST prior from first Exablate thalamotomy
• Men and women age 22 years to 75 years of age.
• Minimum score of 24 on MoCA or 20 on MMSE
• Subjects who are able and willing to give consent and able to attend all study visits
• Postural or intention tremor severity score of greater than or equal to 2 in the both upper extremities as measured by the CRST rating scale while on stable medication
• Thalamus can be targeted by the Exablate device. The region must be apparent on MRI such that targeting can be performed.
• Able to communicate sensations during the Exablate Thalamotomy treatment
• Original (before first Exablate procedure) CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities.
⁃ Subjects on antidepressant medications must be stable for at least 3 months prior to procedure(i.e., no change in medication drug or dosage for 3 months based on historical medical records).
⁃ Remains eligible for Exablate treatment with no changes to medical history that would affect Exablate treatment criteria, (e.g., bleeding/coagulation requirements, or new pathology such as infarct, tumor, etc).