Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Virginia

About this trial

This phase 1 multi-site study investigates the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head and neck cancer and brachial cancer.

Eligibility criteria

Qualifiers

Men and women, between 18 and 85 years, inclusive

Cancer that arises in the head and neck region: nasal cavity, sinuses, lips, mouth, salivary glands, throat, or larynx (typically squamous cell carcinoma)

Cancer occurring in the nasopharynx, skin, thyroid gland, and eye

Cancer involving the brachial region including brachial plexus, upper lung apex, and Pancoast tumors.

Disqualifiers

Idiopathic trigeminal neuralgia

Trigeminal neuropathic pain from trauma, infection, or iatrogenic

Post-herpetic neuralgia

Headache syndromes like migraine, cluster headache

Trial design

Treatments tested in this trial

  • ExAblate Neuro

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Virginia

Lead sponsor

Focused Ultrasound Foundation

Collaborator