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

NCT03894553 | Completed FDA Device

• 1 other identifier: HSR180040
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Number of participants with treatment-related adverse events, as assessed from adverse event reporting throughout the 6 month study period. Additional measures of safety will be made with MRI evaluation.

  6 months post-intervention

• Numeric Pain Rating Scale

  Will compare the change of WORST pain experienced in 24 hours before (baseline) and at 3 months following unilateral FUS mesencephalotomy as determined from the 11-point numeric pain rating scale (0-10), with 0 being no pain and 10 being the worst pain imaginable.

  3 months post-intervention (will also be assessed at 7 days, 1 month, and 6 months post-intervention)

Secondary Outcomes (15)

• Patient Global Impression of Change

  Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention

• PROMIS scale v1.0 - Pain Intensity 3a

  Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention

• PROMIS scale v2.0 - Neuropathic Pain Quality 5a

  Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention

• PROMIS scale v2.0 - Nociceptive Pain Quality 5a

  Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention

• PROMIS scale v1.0 - Pain Behavior 7a

  Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention

Study Arms (1)

FUS Mesencephalotomy

EXPERIMENTAL

Subjects will receive unilateral stereotactic focused ultrasound mesencephalotomy using the ExAblate Neuro device for severe, opioid-resistant pain associated with head and neck cancer.

Device: ExAblate Neuro

Interventions

ExAblate Neuro DEVICE

Unilateral stereotactic focused ultrasound lesioning of the contralateral mesencephalon

FUS Mesencephalotomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, between 18 and 75 years, inclusive
• Subjects with head and neck cancer, including one of the following:
• 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
• Lymphoma
• Sarcoma
• Craniofacial or cervical pain related to the cancer that meets all of the following criteria:
• Severe defined by: Worst NPRS score of ≥ 5 out of 10 at current visit and the subject reports having a similar level of pain for at least the past two months.
• Pain is medication-refractory to all three tiers of the WHO cancer pain ladder. Thus, adequate trials of at least 3 prescription medications that will include a 'weak' and a 'strong' opioid. An adequate medication trial is defined as a therapeutic dose of each medication without sufficient effect.
• Duration of greater than 6 months
• Mesencephalon contralateral to the pain can be targeted by the ExAblate Neuro device. The region of the mesencephalon must be apparent on MRI. Additional MRI sequences including inversion-recovery and DTI may be utilized to refine the target.
• Subjects who are able and willing to give consent and able to attend all study visits
• Subjects who are able to communicate sensations during the focused ultrasound treatment

You may not qualify if:

• Idiopathic trigeminal neuralgia
• Trigeminal neuropathic pain from trauma, infection, or iatrogenic
• Post-herpetic neuralgia
• Headache syndromes like migraine, cluster headache
• Temporomandibular joint syndrome
• Atypical facial pain or pain related to a somatoform disorder
• Subjects deemed poor candidates by a multidisciplinary team of cancer and palliative care clinicians:
• Significant clinician concern about reliability of subject-reported information, such as subject in active process of seeking disability for neuropathic pain
• Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-V as manifested by one (or more) of the following occurring within a 12 month period: Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household). Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
• Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
• Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
• Subjects with active psychiatric illness will be excluded. For the purpose of this study, active psychiatric illness includes:
• Exhibiting current suicide ideation and/or a history of suicide attempt within past 2 years
• been hospitalized for the treatment of a psychiatric illness within the past 2 years
• received transcranial magnetic stimulation for depression treatment

Sponsors & Collaborators

• Jeff Elias, MD: lead

Study Sites (1)

University of Virginia UVA Health, University Hospital

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Facial Pain; Neck Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeff Elias

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurological Surgery

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: March 28, 2019
• Study Start: June 22, 2020
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)