Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain
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|ClinicalTrials.gov Identifier: NCT03309813|
Recruitment Status : Active, not recruiting
First Posted : October 16, 2017
Last Update Posted : August 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Trigeminal Neuropathic Pain||Device: Transcranial ExAblate Device: Sham Transcranial ExAblate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Feasibility Study of Focused Ultrasound to Perform Bilateral Medial Thalamotomy for the Treatment of Chronic Trigeminal Neuropathic Pain|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
Experimental: Transcranial ExAblate
ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS)
Device: Transcranial ExAblate
ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain
Sham Comparator: Sham Transcranial ExAblate
ExAblate MRgFUS Sham Procedure
Device: Sham Transcranial ExAblate
Sham ExAblate Thalamotomy procedure
- Severity of Device and Procedure related complications [ Time Frame: At the time of ExAblate Transcranial thalamotomy procedure. ]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.
- Numeric Pain Rating Scale (NPRS) [ Time Frame: Change in NPRS from before treatment to 3 Months following treatment. ]To compare the change in worst pain experienced over 24 hours before and at 3 months following bilateral FUS medial thalamotomy versus sham procedures as determined from the 11-point numeric pain rating scale.
- Patient Global Impression of Change (PGIC) [ Time Frame: PGIC will be assessed 7 days, 1 month, and 3 months following treatment. ]To assess the patient-reported change in activity, limitations, symptoms, emotions, and overall quality of life following treatment.
- Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory [ Time Frame: PROMIS pain inventory will be assessed before treatment and at 1 day, 7 days, 1 month, and 3 months following treatment. ]To assess the patient-reported PROMIS pain domain questionnaires for pain intensity, quality, behavior, and interference.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309813
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||William J Elias, MD||University of Virginia|