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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with severe pain from head and neck cancer that does not improve with typical medications, including strong painkillers. The treatment uses focused ultrasound, a technology targeting specific brain areas, to determine if it can safely reduce pain. Suitable candidates have experienced this type of cancer-related pain for over six months and have not found relief from at least three different pain medications. As an unphased trial, this study offers patients the chance to explore innovative treatment options that might provide relief when other methods have failed.

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.

What prior data suggests that the ExAblate Neuro device is safe for treating severe pain in head and neck cancer patients?

In earlier studies, the ExAblate Neuro device has been used to reduce pain in patients with head and neck cancer. Research shows that most patients tolerate this treatment well. One study treated five patients with this type of pain, focusing on safety and patient tolerance.

The studies found that while the treatment relieved pain, some patients experienced side effects. These side effects were not serious and could be managed. This indicates the treatment is safe, though minor issues might occur.

For those considering joining the trial, this information provides insight into the treatment's safety. Always consult a doctor for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Focused ultrasound using the ExAblate Neuro device is unique because it offers a non-invasive way to relieve severe, opioid-resistant pain linked to head and neck cancer. Unlike traditional pain management options like opioids, which often come with significant side effects and risk of addiction, this method targets pain directly by using sound waves to interrupt pain pathways in the brain. Researchers are excited because this technique could provide rapid relief without the need for medication, offering a potentially game-changing approach for those who have not found relief from existing treatments.

What evidence suggests that the ExAblate Neuro device is effective for head and neck cancer pain?

Research shows that focused ultrasound, such as the ExAblate Neuro, can reduce severe pain in patients with head and neck cancer when other medications fail. In this trial, participants will undergo unilateral stereotactic focused ultrasound mesencephalotomy using the ExAblate Neuro device. This treatment non-invasively targets specific brain areas to relieve pain. Studies have found that patients experience a noticeable decrease in pain after the treatment. The technique uses detailed imaging to direct ultrasound waves to the mesencephalon, potentially providing effective pain relief. Early results suggest it offers a promising option for those whose pain does not respond to opioids. ^{1 2 3 6 7}

Who Is on the Research Team?

Jeff Elias

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12406951/

Stereotactic Focused Ultrasound Mesencephalotomy for the ... Stereotactic focused ultrasound mesencephalotomy is a modern, image-guided, lesioning technique that may be effective for cancer pain. Keywords: ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03894553

Focused Ultrasound (FUS) Mesencephalotomy for Head & ... Primary efficacy outcome is determined by comparing the difference in baseline NPRS to 3 months post treatment. All subjects receiving treatment will be ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-12740

Stereotactic MRI-Guided Focused Ultrasound ... This study evaluates the safety and effects of the ExAblate Neuro when used for reducing pain related to head and neck cancer.

4. uvahealth.com uvahealth.com/clinical-trials/trial/21281

Clinical Trials | Research study for those with pain resulting ... The purpose of the study is to determine if focused ultrasound can be used to help relieve chronic pain in patients whose medications are not working well to ...

5. withpower.com withpower.com/trial/phase-neck-pain-5-2020-45219

Focused Ultrasound 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 ...

6. uvahealth.com uvahealth.com/clinicaltrials/research-study-those-pain-resulting-head-andor-neck-cancer

Research study for those with pain resulting from head and ... The purpose of the study is to determine if focused ultrasound can be used to help relieve chronic pain in patients whose medications are not working well to ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03894553/focused-ultrasound-fus-mesencephalotomy-for-head-neck-cancer-pain

Focused Ultrasound (FUS) Mesencephalotomy for Head & ... This proposed pilot study will investigate the safety and initial effectiveness of focused ultrasound lesioning of the contralateral ...