At a glance
ClinicalIndex Comparison RecordN/ACompleted· 76 enrolled
Drug / intervention
Transcranial ExAblate +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
In Brief
A clinical study evaluating Transcranial ExAblate and Sham Transcranial ExAblate for Essential Tremor. Completed, enrolled 76 participants across 8 sites in 4 countries.
Detailed Summary
The objective of this prospective, randomized, double-blind (to subjects, local site's blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor (ET).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Tremor
CountriesCanada, Japan, South Korea, United States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 2013
Enrollment StartMay 2013
Primary CompletionFeb 2021
TodayJul 2026
First PostedApr 10, 2013
Enrollment StartMay 1, 2013
Primary CompletionFeb 24, 2021
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 13.2 years ago
Interventions
Transcranial ExAblatedevice
Sham Transcranial ExAblatedevice