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 groupLocations
6Brigham and Women's Hospital02115, BostonMassachusetts, United States
Weill Cornell Medicine10065, New YorkNew York, United States
Oregon Health and Science University97239, PortlandOregon, United States
The University of Texas Southwestern Medical Center75390, DallasTexas, United States
Sponsors and collaborators
University of Virginia
Lead sponsor
Focused Ultrasound Foundation
Collaborator
Source ClinicalTrials.gov