Who is eligible for clinical trial NCT04579692?

Participants must meet the protocol's inclusion criteria for Trigeminal Neuralgia. The stated age range is 21 Years to 75 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04579692 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-16

MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia (NCT04579692)

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

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: University of Maryland, Baltimore

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (21 items).

Location: University of Maryland Medical Center — Baltimore, Maryland

Age range: 21 Years to 75 Years

🧪 Interventions in This Study

ExAblate Transcranial treatment (DEVICE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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
Two members of the medical team have agreed upon inclusion and exclusion criteria.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Maryland Medical Center — Baltimore, Maryland

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Trigeminal Neuralgia

Trigeminal Evoked Responses to Improve Rhizotomy — Minneapolis, Minnesota
RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia — Sherbrooke,
Emotion and Memory in Chronic Neuropathic Pain — Toronto, Ontario
Post-Operative Trigeminal Pain After Microvascular Decompression for Trigeminal Neuralgia — Newark, New Jersey
Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion — Sherbrooke, Quebec

Explore by condition: All Trigeminal Neuralgia clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗