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

NCT04579692 | Active Not Recruiting DMC FDA Device

• 1 other identifier: HP-00092927
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Trigeminal pain; MR guided focused ultrasound

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment related adverse events

  Procedure related or device related adverse events will be reported, from the treatment day through the 6-month follow-up period.

  All events will be reported up to 6 months from treatment

Secondary Outcomes (4)

• Change in pain intensity

  6 months

• Change in pain intensity

  6 months

• Change in pain intensity

  6 months

• Change in patient's perception of the effect of the procedure

  6 months

Study Arms (1)

ExAblate Transcranial treatment

EXPERIMENTAL

The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . The ExAblate uses ultrasound to heat a small spot in the brain called central lateral thalamic nucleus. Ultrasound passes through the skin and skull and into the brain to focus on this particular spot.

Device: ExAblate Transcranial treatment

Interventions

ExAblate Transcranial treatment DEVICE

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.

Also known as: The ExAblate® MR guided focused ultrasound system

ExAblate Transcranial treatment

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical Diagnosis of Classical or Idiopathic TN refractory to medical therapy
• Age greater than 21 and less than 75 years
• Subjects who are able and willing to give consent and able to attend all study visits
• Documented chronic, severe pain for more than 6 months duration
• Failure to respond to the usual therapeutic regimen considered to be standard of care for Trigeminal Neuralgia. The patient should have failed a trial of at least two classes of therapeutic agents, including an anticonvulsant agent
• Patient with Trigeminal Neuralagia who has either failed a prior surgical approach considered to be standard of care for TN (Micro-vascular decompression, radiofrequency, stereotactic, Radiosurgery or glycerol) or is not considered to be an acceptable candidate for one of those alternative options (due to anesthesia risk, medical comorbidities or Patient refusal despite counseling).
• Central lateral thalamotomy is feasible based on evaluation of imaging studies
• Patient able to communicate sensations during the Exablate TcMRgFUS treatment

You may not qualify if:

• Patient with contra-indications to MRI such as severe claustrophobia and metallic implants incompatible with MRI.
• Severe psychiatric disorder such as uncontrolled depression, bipolar disorder, prior attempt at suicide or suicide ideation in preceding 12 months
• Life expectancy less than 12 months
• Anticoagulant or antiplatelet medications as well as underlying coagulopathy
• Prior or currently implanted thalamic DBS
• Pregnant ladies or women of childbearing age who are sexually active and not using contraception
• Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia
• Presence of intracranial mass or an acute intracranial abnormality
• Subjects with unstable cardiac status such as Unstable angina pectoris, documented myocardial infarction within 6 months of protocol entry and ejection fraction less than 40
• Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV.
• Severe hypertension (diastolic BP \> 100 on medication or persistently elevated SBP\>140 mmHg despite adequate antihypertensive medications)
• History of immunocompromise including those who are HIV positive.
• History of intracranial hemorrhage, traumatic brain injury or thalamic stroke.
• Cerebrovascular disease (multiple CVA or CVA within 6 months)
• Subjects with life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• InSightec: collaborator
• Focused Ultrasound Foundation: collaborator

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Dheeraj Gandhi, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology, Neurology and Neurosurgery

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 8, 2020
• Study Start: August 16, 2021
• Primary Completion: May 28, 2025
• Study Completion (Estimated): May 28, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)