Neoplasms

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Head and Neck Neoplasms

Cancer Pain

Pain

Facies

Neck Pain

Facial Pain

Neurologic Manifestations

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics, Opioid

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

Unilateral stereotactic focused ultrasound lesioning of the contralateral mesencephalon

ExAblate Neuro

Zak Sturgill

Matthew Patterson

Jeff Elias

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

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.

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

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

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.

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.

Change from baseline scores to post-intervention time points (see below), as measured by a patient questionnaire that asks patients to describe the change (if any) compared to their condition prior to treatment in activity, limitations, symptoms, emotions, and overall quality of life, related to their painful condition. The options include no change, almost the same, a little better, somewhat better, moderately better, better, and a great deal better.

Change from baseline scores to post-intervention time points (see below). The first two items in the Pain Intensity item bank assess pain intensity utilizing a 7-day recall period (items include the phrase "the past 7 days") while the last item asks patient to rate their pain intensity "right now." The Pain Intensity instrument is available for adults (ages 18+). Scale includes range from 1-5, with 1 = "Had no pain" and 5 = "Very severe".

Change from baseline scores to post-intervention time points (see below), as assessed by patient questionnaire that asks about pain quality in the past 7 days, specifically asking if the pain has felt like pins and needles, tingly, stinging, electrical, or numb, on a scale from 1-5, with 1 = "Not at all" and 5 = "Very much".

Change from baseline scores to post-intervention time points (see below), as assessed by patient questionnaire that asks about pain quality in the past 7 days, specifically asking if the pain has felt sore, tender, achy, deep, or steady, on a scale from 1-5, with 1 = "Not at all" and 5 = "Very much".

Change from baseline scores to post-intervention time points (see below), as assessed by patient questionnaire that measures self-reported external manifestations of pain in the past 7 days, including actions and reactions that can be either verbal or nonverbal, and involuntary or deliberate. Measured on a scale from 1-6, with 1 = "Had no pain" and 6 = "Always".

Change from baseline scores to post-intervention time points (see below), as assessed by patient questionnaire that measures self-reported consequences of pain on relevant aspects of one's life in the past 7 days. Includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Also incorporates items probing sleep and enjoyment in life. Measured on scale from 1-5, with 1 = "Not at all" and 5 = "Very much".

Change from baseline scores to post-intervention time points (see below), as assessed by patient questionnaire that measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness), in the past 7 days. Measured on scale from 1-5, with 1 = "Never" and 5 = "Always".

Change from baseline scores to post-intervention time points (see below), as assessed by patient questionnaire that measures self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose), in the past 7 days. Somatic symptoms (changes in appetite, sleeping patterns) are not included, which eliminates consideration of these items' confounding effects when assessing patients with comorbid physical conditions. Measured on a scale from 1-5, with 1 = "Never" and 5 = "Always".

Change from baseline scores to post-intervention time points (see below), as assessed by patient questionnaire that measures a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The Fatigue short form is universal rather than disease-specific. It assesses fatigue over the past seven days. Measured on a scale from 1-5, with 1 = "Never" and 5 = "Always".

Change from baseline scores to post-intervention time points (see below), as assessed by patient questionnaire that measures self-reported capability rather than actual performance of physical activities. Measured on a scale from 5 to 1, with 5 = "Without any difficulty" and 1 = "Unable to do".

Change from baseline scores to post-intervention time points (see below), as assessed by patient questionnaire that asks participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time.

Change of the amount of morphine that is used by patient daily, in daily morphine equivalents (in milligrams), from baseline through 6 months post-intervention.

The location of the lesion will be measured in the x, y, and z dimensions, and will be reported in mm.

The precision of the lesion will be measured in the x, y, and z dimensions, but also in a two dimensional radial vector, all reported in mm.

The volume of the lesion will be measured in mm3.

Spots Global Cancer Trial Database for pain, face

Every month we try and update this database with for pain, face cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pain, face

Every month we try and update this database with for pain, face cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pain, face cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.