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Focused Ultrasound

Focused Ultrasound for Head and Neck Cancer Pain

N/A

Recruiting

Led By Jeff Elias

Research Sponsored by Jeff Elias, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects who are able to communicate sensations during the focused ultrasound treatment

Men and women, between 18 and 75 years, inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-intervention

Awards & highlights

Study Summary

This trial will test if focused ultrasound can safely and effectively treat severe pain associated with head and neck cancer that doesn't respond to opioids.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort at the treatment site, headache or dizziness post-treatment. There could also be risks associated with lying still for long periods and specific reactions related to ultrasound energy exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can communicate how I feel during the ultrasound treatment.

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Numeric Pain Rating Scale

Secondary outcome measures

Morphine

Location of lesion in the x, y, z dimensions in mm

PROMIS - Ca Bank v1.1 - Physical Function

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: FUS MesencephalotomyExperimental Treatment1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jeff Elias, MDLead Sponsor

1 Previous Clinical Trials

4 Total Patients Enrolled

Jeff Elias3.68 ReviewsPrincipal Investigator - University of Virginia

University of Virginia

Media Library

ExAblate Neuro (Focused Ultrasound) Clinical Trial Eligibility Overview. Trial Name: NCT03894553 — N/A

Head and Neck Cancers Research Study Groups: FUS Mesencephalotomy

Head and Neck Cancers Clinical Trial 2023: ExAblate Neuro Highlights & Side Effects. Trial Name: NCT03894553 — N/A

ExAblate Neuro (Focused Ultrasound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03894553 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participation of people below 80 years old mandated for this research?

"This clinical trial requires potential participants to be in the 18-75 age range. Additionally, there are 18 trials available for minors and 462 studies open to those 65 and older."

Answered by AI

Is it possible for me to partake in this research project?

"This clinical trial is recruiting 6 individuals between the ages of 18-75 who have had significant neck pain for a minimum of two months. Candidates must meet additional requirements such as: being male or female, having cancer in particular areas (nasal cavity, sinuses, lips, mouth etc.), must not have responded to traditional medications and treatments outlined by the WHO Cancer Pain Ladder; they must also be able to attend all study visits and give consent. MRI scans will be used to pinpoint exactly where ExAblate Neuro device should target."

Answered by AI

Is enrollment for this trial still available?

"As per the details on clinicaltrials.gov, this medical research is currently in its recruitment phase. The trial was initially launched June 22nd 2020 and has undergone a recent update to reflect new data as of April 22nd 2022."

Answered by AI

What are the main goals that this exploration is seeking to accomplish?

"The primary objective of this research is to observe any adverse events over a three month period, as well as at 7 days, 1 month and 6 months post-intervention. Additionally, secondary outcomes will include measuring the volume (in mm3) of lesions; locating said lesions with respect to x/y/z dimensions (measured in mm); and gauging patients' physical functioning via patient questionnaire scores ranging from 5 ("Without any difficulty") to 1 ("Unable to do")."

Answered by AI

What is the patient quota for this scientific experiment?

"Affirmative. According to the data found on clinicaltrials.gov, this medical investigation is still actively seeking participants; it was initially posted on June 22nd 2020 and most recently updated April 22nd 2022. The study requires 6 individuals from a single site for recruitment purposes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jeff Elias, MD 2020. "Focused Ultrasound (FUS) Mesencephalotomy for Head & Neck Cancer Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03894553.

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