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Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain

NCT03309813 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-10-03

Study results available
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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.

Conditions

  • Trigeminal Neuropathic Pain

Interventions

DEVICE

Transcranial ExAblate

ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain

DEVICE

Sham Transcranial ExAblate

Sham ExAblate Thalamotomy procedure

DEVICE

Crossover Transcranial Exablate

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.

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • William J Elias, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03309813 on ClinicalTrials.gov