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ACTIVE NOT RECRUITING
NCT04579692
NA

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

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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.

Official title: Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Thalamotomy of Central Lateral Thalamic Nucleus for the Treatment of Medication-refractory Trigeminal Neuralgia

Key Details

Gender

All

Age Range

21 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2021-08-16

Completion Date

2026-05-28

Last Updated

2026-01-28

Healthy Volunteers

No

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.

Locations (1)

University of Maryland Medical Center

Baltimore, Maryland, United States