Sponsor study identifier
interventional
10
1 country
1
Study Start
December 1, 2017
Actual (reported)Primary Completion
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this prospective, randomized, sham-controlled, crossover study is to evaluate the safety and feasibility of ExAblate Neuro treatment of chronic trigeminal neuropathic pain.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 5, 2017
Actual (reported)October 16, 2017
Actual (reported)December 1, 2017
Actual (reported)October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 3, 2023
Actual (reported)Severity of Device and Procedure Related Complications
To evaluate the incidence and severity of adverse events associated with ExAblate lesioning of the bilateral medial thalamus for painful neuropathies of the face and head that are severe and treatment-refractory.
At the time of ExAblate Transcranial thalamotomy procedure through 3-months post-thalamotomy
Numeric Pain Rating Scale (NPRS)
Numeric Pain Rating Scale (NPRS) change in worst pain experienced over 24 hours before and at 3 months following bilateral FUS medial thalamotomy versus sham procedures was determined from the 11-point numeric pain rating scale with 0 as no pain and 10 the worst pain imaginable. High NPRS scores are worse pain (0 is no pain, 10 is maximum). Percent change from Baseline at Month 3 was calculated as follows: 100\*(NPRS Score at Baseline - NPRS Score at Month 3)/NPRS Score at Baseline. High percent change in NPRS Score from Baseline is better (improved pain).
Percent Change in NPRS from before treatment to 3 Months following treatment.
Pain Interference Scale 8a v1.0 From the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory
From pre-treatment through 3 months following treatment.
ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS)
ExAblate MRgFUS Sham Procedure
ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain
Sham ExAblate Thalamotomy procedure
University of Virginia
Charlottesville, Virginia, 22908, United States
Ishaque M, Moosa S, Urban L, Kundu B, Qureshi Z, Spears T, Fletcher PT, Donahue J, Patel SH, Goldstein RB, Finan PH, Liu CC, Elias WJ. Bilateral focused ultrasound medial thalamotomies for trigeminal neuropathic pain: a randomized controlled study. J Neurosurg. 2023 Dec 29;140(6):1799-1809. doi: 10.3171/2023.10.JNS23661. Print 2024 Jun 1.
This is a pilot study with limited sample size.
William J Elias, MD
University of Virginia
10 participants (actual enrollment reported by the registry).
First Submitted
October 5, 2017
First Posted
October 16, 2017
Study Start
Subjects randomized to the Sham Exablate could opt for the Crossovover Transcranial Exablate Arm (Exablate Thalamotomy) after completing the Month 3 visit in the Sham Arm.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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December 1, 2017
Actual (reported)Primary Completion
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 3, 2023
Results First Posted
October 3, 2023
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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