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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FUS Mesencephalotomy | Experimental | Subjects will receive unilateral stereotactic focused ultrasound mesencephalotomy using the ExAblate Neuro device for severe, opioid-resistant pain associated with head and neck cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExAblate Neuro | Device | Unilateral stereotactic focused ultrasound lesioning of the contralateral mesencephalon |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 3 months post-intervention (will also be assessed at 7 days, 1 month, and 6 months post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Men and women, between 18 and 75 years, inclusive
Subjects with head and neck cancer, including one of the following:
Craniofacial or cervical pain related to the cancer that meets all of the following criteria:
Mesencephalon contralateral to the pain can be targeted by the ExAblate Neuro device. The region of the mesencephalon must be apparent on MRI. Additional MRI sequences including inversion-recovery and DTI may be utilized to refine the target.
Subjects who are able and willing to give consent and able to attend all study visits
Subjects who are able to communicate sensations during the focused ultrasound treatment
Exclusion Criteria:
Idiopathic trigeminal neuralgia
Trigeminal neuropathic pain from trauma, infection, or iatrogenic
Post-herpetic neuralgia
Headache syndromes like migraine, cluster headache
Temporomandibular joint syndrome
Atypical facial pain or pain related to a somatoform disorder
Subjects deemed poor candidates by a multidisciplinary team of cancer and palliative care clinicians:
Subjects with active psychiatric illness will be excluded. For the purpose of this study, active psychiatric illness includes:
Subjects with unstable cardiac status including:
Severe hypertension (diastolic BP > 100 on medication)
Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
On medications that increases the bleeding risk, based on the published guidelines which are currently recognized by the American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine and the North American Neuromodulation Society (Reg Anesth Pain Med 2015;40: 182-212); specifically:
Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hours of total table time.)
Subjects participating or have participated in another clinical trial in the last 30 days
Subjects with risk factors for intraoperative or postoperative bleeding from a documented coagulopathy or if their serum coagulation studies (platelet count, PT, PTT, and INR) exceed the institutional laboratory limits.
Subjects with brain tumors or any significant intracranial mass.
Any illness that in the investigator's opinion preclude participation in this study
Pregnancy or lactation
Legal incapacity or limited legal capacity
Subjects with a deep brain stimulation implant
Skull density ratio, calculated from the baseline non-contrasted head CT, is less than 0.4
History of hemorrhagic stroke or cerebrovascular event within the past year of treatment exhibiting incomplete resolution
Subjects whose primary pain is other than craniofacial neuropathic pain.
Patients deemed high risk because of their airway for the procedure as evaluated by anesthesia.
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Elias | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia UVA Health, University Hospital | Charlottesville | Virginia | 22903 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D005157 | Facial Pain |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| 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". | Baseline, 7 days, 1 month, 3 months, and 6 months post-intervention |
| PROMIS scale v2.0 - Neuropathic 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 like pins and needles, tingly, stinging, electrical, or numb, on a scale from 1-5, with 1 = "Not at all" and 5 = "Very much". | 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". | 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". | 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". | 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". | 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". | 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". | 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". | 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. | 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. | 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. | 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. | 7 days and 3 months post-intervention |
| Volume of lesion in mm3 | The volume of the lesion will be measured in mm3. | 7 days and 3 months post-intervention |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |