Focused Ultrasound for Head and Neck Cancer Pain

Overseen By Zak Sturgill

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jeff Elias, MD

Must be taking: Opioids

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Psychiatric illness, Cardiac issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

6 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you will need to stop taking certain medications that increase bleeding risk, such as aspirin or anticoagulants, for a specified period before treatment.

How is the treatment ExAblate Neuro unique for head and neck cancer pain?

ExAblate Neuro is a unique treatment for head and neck cancer pain because it uses focused ultrasound, a non-invasive technique that targets and heats specific areas of the brain to relieve pain without the need for surgery or medication. This approach is different from traditional pain management methods like opioids or radiation, which can have significant side effects. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Research Team

Jeff Elias

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for adults aged 18-75 with severe pain from head and neck cancer, who haven't found relief with opioids. Participants must have stable medication doses for a month before the study and be able to communicate during treatment. Exclusions include certain neuralgias, unstable heart conditions, bleeding risks, recent other trials participation, brain tumors or masses, pregnancy, psychiatric illness among others.

Inclusion Criteria

I can communicate how I feel during the ultrasound treatment.

My pain medication doses have been stable for the last 30 days.

Subjects who are able and willing to give consent and attend all study visits

Exclusion Criteria

Pregnancy or lactation

Subjects participating or have participated in another clinical trial in the last 30 days

I experience facial pain not caused by a known physical condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 7 days, 1 month, 3 months, and 6 months post-intervention

6 months

Treatment Details

Interventions

• ExAblate Neuro

Trial Overview The study tests the safety and initial effectiveness of Focused Ultrasound (FUS) Mesencephalotomy—a procedure targeting part of the midbrain—to relieve persistent pain in patients with head & neck cancer that doesn’t respond to standard opioid treatments.

Participant Groups

Group I: FUS Mesencephalotomy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Jeff Elias, MD

Lead Sponsor

Trials

2

Recruited

10+

References

1. France pubmed.ncbi.nlm.nih.gov

Management of somatic pain induced by head and neck cancer treatment: pain following radiation therapy and chemotherapy. Guidelines of the French Otorhinolaryngology Head and Neck Surgery Society (SFORL). [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Neuropathic pain prevalence and risk factors in head and neck cancer survivors. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Pain and loss of function in head and neck cancer survivors. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The role of pain in head and neck cancer recurrence and survivorship. [2015]

5. India pubmed.ncbi.nlm.nih.gov

The burden of chronic pain after major head and neck tumor therapy. [2020]