NCT03894553

Focused Ultrasound (FUS) Mesencephalotomy for Head & Neck Cancer Pain

Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy for Pain Palliation in Head & Neck Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Jeff Elias, MD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This proposed pilot study will investigate the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe, opioid-resistant pain associated with head and neck cancer

Detailed description

This pilot study is designed as a prospective, open-label clinical trial of stereotactic FUS mesencephalotomy in 6 subjects with treatment-refractory pain from head and neck cancer. Primary safety assessments will be made throughout the study period of 6 months following the procedure. Primary efficacy outcome is determined by comparing the difference in baseline NPRS to 3 months post treatment. All subjects receiving treatment will be followed for the six month study period.

Conditions

• Cancer of Head and Neck
• Pain, Face
• Pain, Neck

Interventions

Type	Name	Description
DEVICE	ExAblate Neuro	Unilateral stereotactic focused ultrasound lesioning of the contralateral mesencephalon

Timeline

• Start date: 2020-06-22
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2019-03-28
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study