Spots Global Cancer Trial Database for Focused Ultrasound (FUS) Mesencephalotomy for Head & Neck Cancer Pain

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Trial Identification

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

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

Study ID: NCT03894553

Conditions

Cancer of Head and Neck

Pain, Face

Pain, Neck

Interventions

ExAblate Neuro

Study Description

Brief 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.