Actively Recruiting
Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy
Led by University of Virginia · Updated on 2026-02-12
20
Participants Needed
6
Research Sites
202 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
F
Focused Ultrasound Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women between 18 and 85 years old
- Diagnosed with head, neck, or brachial cancer including nasal cavity, sinuses, lips, mouth, salivary glands, throat, larynx, nasopharynx, skin, thyroid gland, eye, brachial plexus, upper lung apex, Pancoast tumors, lymphoma, or sarcoma
- Craniofacial, cervical, or brachial pain related to cancer that is severe (worst pain score 5 or higher) and persistent for at least 2 months
- Pain resistant to at least three prescription medications including weak and strong opioids
- Duration of pain longer than 3 months
- Contralateral mesencephalon target visible on MRI suitable for ExAblate Neuro device
- Able and willing to give consent and attend all study visits
- Able to communicate sensations during focused ultrasound treatment
You will not qualify if you...
- Idiopathic trigeminal neuralgia
- Trigeminal neuropathic pain due to trauma, infection, or medical intervention
- Post-herpetic neuralgia
- Headache syndromes such as migraine or cluster headache
- Temporomandibular joint syndrome
- Atypical facial pain or somatoform disorder-related pain
- Poor candidates as determined by cancer and palliative care clinicians, including limited life expectancy under 3 months
- Unreliable self-reporting or active substance abuse
- Active psychiatric illness including recent suicidal ideation, hospitalization, psychosis, or certain treatments for depression
- Unstable heart conditions including recent heart attack, heart failure, or uncontrolled arrhythmias
- Severe hypertension (diastolic blood pressure over 100 on medication)
- Contraindications to MRI such as non-compatible implants or size limitations
- Use of medications that increase bleeding risk within specific time frames
- Unable to tolerate prolonged stationary supine position up to 4 hours
- Participation in another pain management trial within the last 30 days
- Bleeding risk due to coagulopathy or abnormal lab tests
- Brain tumors or intracranial masses that block ultrasound except certain cerebral metastases
- Any illness that prevents safe participation
- Pregnancy or breastfeeding
- Legal incapacity or limited legal capacity
- Presence of deep brain stimulation implant
- Skull density ratio less than 0.4
- Recent hemorrhagic stroke or cerebrovascular event within past year with incomplete recovery
- Primary pain not related to craniofacial or brachial neuropathic pain
- High airway risk for procedure as assessed by anesthesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
2
Weill Cornell Medicine
New York, New York, United States, 10065
Not Yet Recruiting
3
Oregon Health and Science University
Portland, Oregon, United States, 97239
Not Yet Recruiting
4
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Not Yet Recruiting
5
Baylor College of Medicine
Houston, Texas, United States, 77054
Not Yet Recruiting
6
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
W
William J Elias, MD
CONTACT
M
Marian Abdelmalek, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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