At a glance
ClinicalIndex Comparison RecordN/AUnknown· 10 enrolled
Drug / intervention
Transcranial ExAblate +2 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 Feasibility Study of Focused Ultrasound to Perform Bilateral Medial Thalamotomy for the Treatment of Chronic Trigeminal Neuropathic Pain
In Brief
A clinical study evaluating Transcranial ExAblate, Sham Transcranial ExAblate, and 1 other intervention for Trigeminal Neuropathic Pain. Targeting 10 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrigeminal Neuropathic Pain
CountriesUnited States
Collaborators--
Timeline
N/AUnknownOverdue
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartDec 2017
Primary CompletionOct 2023
TodayJul 2026
First PostedOct 16, 2017
Enrollment StartDec 1, 2017
Primary CompletionOct 1, 2023
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 8.7 years ago
Interventions
Transcranial ExAblatedevice
ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain
Sham Transcranial ExAblatedevice
Sham ExAblate Thalamotomy procedure
Crossover Transcranial Exablatedevice
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.