Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
Spain, United Kingdom7 participantsStarted 2019-01-03
Plain-language summary
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.
Who can participate
Age range22 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Subjects with unstable cardiac status
✕. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
✕. Subjects with uncontrollable blood pressure (hypertensive with diastolic BP \> 100 on medication)
What they're measuring
1
Clinical Rating Scale for Tremor (CRST)
Timeframe: Baseline through Month 12 after First and Second Treatment
2
Incidence of Device and Procedure related Adverse Events
Timeframe: Treatment through Month 12 after Second Treatment
. History of abnormal bleeding and/or coagulopathy, i.e. subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter, a documented clinical coagulopathy, or INR coagulation studies exceeding the institution's laboratory standard
✕. Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
✕. Active or suspected acute or chronic uncontrolled infection
✕. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.)
✕. Subjects with life-threatening systemic disease that include but not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc...