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MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia

NCT04579692 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-28

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects.

Conditions

  • Trigeminal Neuralgia

Interventions

DEVICE

ExAblate Transcranial treatment

Patients' head will be placed in ExAblate device to hold it still for the treatment. The ExAblate Transcranial helmet will be placed on their head. The investigators will measure the study participant's heart, blood pressure, temperature, and breathing rate before the treatment begins. MRI scans will be taken to make sure the ultrasound waves will be aimed exactly within the target. A series of MR images will be taken to identify the target area, and plan the study treatment. The study investigators will decide on the area of participant's brain that will be treated. The ExAblate Transcranial system will compute a plan to cover the treatment area. This area is gradually heated while monitoring the patient's responses and neurologic examination.

Sponsors & Collaborators

  • Focused Ultrasound Foundation

    collaborator OTHER

  • InSightec

    collaborator INDUSTRY

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Dheeraj Gandhi, MD · University of Maryland, Baltimore

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2025-05-28
Completion
2026-05-28
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04579692 on ClinicalTrials.gov