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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Unilateral stereotactic focused ultrasound lesioning of the contralateral mesencephalon
University of Virginia UVA Health, University Hospital
Charlottesville, Virginia, United States
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.
Time frame: 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.
Time frame: 3 months post-intervention (will also be assessed at 7 days, 1 month, and 6 months post-intervention)
Patient Global Impression of Change
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.
Time frame: Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention
PROMIS scale v1.0 - Pain Intensity 3a
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".
Time frame: Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention
PROMIS scale v2.0 - Neuropathic Pain Quality 5a
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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".
Time frame: Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention
PROMIS scale v2.0 - Nociceptive Pain Quality 5a
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".
Time frame: Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention
PROMIS scale v1.0 - Pain Behavior 7a
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".
Time frame: Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention
PROMIS scale v1.0 - Pain Interference 8a
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".
Time frame: Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention
PROMIS - Ca Item Bank v1.0 - Emotional Distress-Anxiety
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".
Time frame: Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention
PROMIS - Ca Item Bank v1.0 - Emotional Distress-Depression
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".
Time frame: Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention
PROMIS - Ca Item Bank v1.0 - Fatigue
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".
Time frame: Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention
PROMIS - Ca Bank v1.1 - Physical Function
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".
Time frame: Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention
Pain Catastrophizing Scale
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.
Time frame: Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention
Daily morphine equivalents (milligrams)
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.
Time frame: Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention
Location of lesion in the x, y, z dimensions in mm
The location of the lesion will be measured in the x, y, and z dimensions, and will be reported in mm.
Time frame: 7 days and 3 months post-intervention
Precision of lesion in the x, y, z dimensions and two dimensional radial vector 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.
Time frame: 7 days and 3 months post-intervention
Volume of lesion in mm3
The volume of the lesion will be measured in mm3.
Time frame: 7 days and 3 months post-intervention