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

Primary Purpose

Cancer of Head and Neck, Pain, Face, Pain, Neck

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ExAblate Neuro
Sponsored by
Jeff Elias, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Head and Neck

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women, between 18 and 75 years, inclusive
  2. Subjects with head and neck cancer, including one of the following:

    • Cancer that arises in the head and neck region: nasal cavity, sinuses, lips, mouth, salivary glands, throat, or larynx (typically squamous cell carcinoma)
    • Cancer occurring in the nasopharynx, skin, thyroid gland, and eye
    • Lymphoma
    • Sarcoma
  3. Craniofacial or cervical pain related to the cancer that meets all of the following criteria:

    • Severe defined by: Worst NPRS score of ≥ 5 out of 10 at current visit and the subject reports having a similar level of pain for at least the past two months.
    • Pain is medication-refractory to all three tiers of the WHO cancer pain ladder. Thus, adequate trials of at least 3 prescription medications that will include a 'weak' and a 'strong' opioid. An adequate medication trial is defined as a therapeutic dose of each medication without sufficient effect.
    • Duration of greater than 6 months
  4. 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.
  5. Subjects who are able and willing to give consent and able to attend all study visits
  6. Subjects who are able to communicate sensations during the focused ultrasound treatment
  7. Stable prescribed doses of all symptomatic pain medications for 30 days prior to screening visit.

Exclusion Criteria:

  1. Idiopathic trigeminal neuralgia
  2. Trigeminal neuropathic pain from trauma, infection, or iatrogenic
  3. Post-herpetic neuralgia
  4. Headache syndromes like migraine, cluster headache
  5. Temporomandibular joint syndrome
  6. Atypical facial pain or pain related to a somatoform disorder
  7. Subjects deemed poor candidates by a multidisciplinary team of cancer and palliative care clinicians:

    1. Significant clinician concern about reliability of subject-reported information, such as subject in active process of seeking disability for neuropathic pain
    2. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-V as manifested by one (or more) of the following occurring within a 12 month period: Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household). Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
    3. Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
    4. Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
  8. Subjects with active psychiatric illness will be excluded. For the purpose of this study, active psychiatric illness includes:

    1. Exhibiting current suicide ideation and/or a history of suicide attempt within past 2 years
    2. been hospitalized for the treatment of a psychiatric illness within the past 2 years
    3. received transcranial magnetic stimulation for depression treatment
    4. received electroconvulsive therapy for depression
    5. any presence or history of psychosis
  9. Subjects with unstable cardiac status including:

    1. Unstable angina pectoris on medication
    2. Subjects with documented myocardial infarction within six months of protocol entry
    3. Significant congestive heart failure defined with ejection fraction < 40
    4. Subjects with unstable ventricular arrhythmias
    5. Subjects with atrial arrhythmias that are not rate-controlled
  10. Severe hypertension (diastolic BP > 100 on medication)
  11. Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
  12. 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:

    1. Aspirin or another antiplatelet medication (clopidogrel, prasugrel, ticlopidine, abciximab) for the last 7 days prior to treatment.
    2. Oral, subcutaneous or intravenous anticoagulant medications, such as oral vitamin K inhibitors for the last 7 days, non-vitamin K inhibitor oral anticoagulant (dabigatran, apixaban, rivaroxaban) for the last 72 hours.
    3. Intravenous or subcutaneous heparin-derived compounds for the last 48 hours.
  13. 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.)
  14. Subjects participating or have participated in another clinical trial in the last 30 days
  15. 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.
  16. Subjects with brain tumors or any significant intracranial mass.
  17. Any illness that in the investigator's opinion preclude participation in this study
  18. Pregnancy or lactation
  19. Legal incapacity or limited legal capacity
  20. Subjects with a deep brain stimulation implant
  21. Skull density ratio, calculated from the baseline non-contrasted head CT, is less than 0.4
  22. History of hemorrhagic stroke or cerebrovascular event within the past year of treatment exhibiting incomplete resolution
  23. Subjects whose primary pain is other than craniofacial neuropathic pain.

Sites / Locations

  • University of Virginia UVA Health, University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FUS Mesencephalotomy

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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".
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".
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".
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".
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".
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".
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".
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".
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".
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.
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.
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.
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.
Volume of lesion in mm3
The volume of the lesion will be measured in mm3.

Full Information

First Posted
November 12, 2018
Last Updated
May 2, 2023
Sponsor
Jeff Elias, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03894553
Brief Title
Focused Ultrasound (FUS) Mesencephalotomy for Head & Neck Cancer Pain
Official Title
Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy for Pain Palliation in Head & Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeff Elias, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Head and Neck, Pain, Face, Pain, Neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FUS Mesencephalotomy
Arm Type
Experimental
Arm Description
Subjects will receive unilateral stereotactic focused ultrasound mesencephalotomy using the ExAblate Neuro device for severe, opioid-resistant pain associated with head and neck cancer.
Intervention Type
Device
Intervention Name(s)
ExAblate Neuro
Intervention Description
Unilateral stereotactic focused ultrasound lesioning of the contralateral mesencephalon
Primary Outcome Measure Information:
Title
Adverse Events
Description
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
Title
Numeric Pain Rating Scale
Description
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)
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change
Description
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
Title
PROMIS scale v1.0 - Pain Intensity 3a
Description
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
Title
PROMIS scale v2.0 - Neuropathic Pain Quality 5a
Description
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
Title
PROMIS scale v2.0 - Nociceptive Pain Quality 5a
Description
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
Title
PROMIS scale v1.0 - Pain Behavior 7a
Description
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
Title
PROMIS scale v1.0 - Pain Interference 8a
Description
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
Title
PROMIS - Ca Item Bank v1.0 - Emotional Distress-Anxiety
Description
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
Title
PROMIS - Ca Item Bank v1.0 - Emotional Distress-Depression
Description
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
Title
PROMIS - Ca Item Bank v1.0 - Fatigue
Description
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
Title
PROMIS - Ca Bank v1.1 - Physical Function
Description
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
Title
Pain Catastrophizing Scale
Description
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
Title
Daily morphine equivalents (milligrams)
Description
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
Title
Location of lesion in the x, y, z dimensions in mm
Description
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
Title
Precision of lesion in the x, y, z dimensions and two dimensional radial vector in mm
Description
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
Title
Volume of lesion in mm3
Description
The volume of the lesion will be measured in mm3.
Time Frame
7 days and 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women, between 18 and 75 years, inclusive Subjects with head and neck cancer, including one of the following: Cancer that arises in the head and neck region: nasal cavity, sinuses, lips, mouth, salivary glands, throat, or larynx (typically squamous cell carcinoma) Cancer occurring in the nasopharynx, skin, thyroid gland, and eye Lymphoma Sarcoma Craniofacial or cervical pain related to the cancer that meets all of the following criteria: Severe defined by: Worst NPRS score of ≥ 5 out of 10 at current visit and the subject reports having a similar level of pain for at least the past two months. Pain is medication-refractory to all three tiers of the WHO cancer pain ladder. Thus, adequate trials of at least 3 prescription medications that will include a 'weak' and a 'strong' opioid. An adequate medication trial is defined as a therapeutic dose of each medication without sufficient effect. Duration of greater than 6 months 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 Stable prescribed doses of all symptomatic pain medications for 30 days prior to screening visit. 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: Significant clinician concern about reliability of subject-reported information, such as subject in active process of seeking disability for neuropathic pain Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-V as manifested by one (or more) of the following occurring within a 12 month period: Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household). Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use) Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct) Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights). Subjects with active psychiatric illness will be excluded. For the purpose of this study, active psychiatric illness includes: Exhibiting current suicide ideation and/or a history of suicide attempt within past 2 years been hospitalized for the treatment of a psychiatric illness within the past 2 years received transcranial magnetic stimulation for depression treatment received electroconvulsive therapy for depression any presence or history of psychosis Subjects with unstable cardiac status including: Unstable angina pectoris on medication Subjects with documented myocardial infarction within six months of protocol entry Significant congestive heart failure defined with ejection fraction < 40 Subjects with unstable ventricular arrhythmias Subjects with atrial arrhythmias that are not rate-controlled 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: Aspirin or another antiplatelet medication (clopidogrel, prasugrel, ticlopidine, abciximab) for the last 7 days prior to treatment. Oral, subcutaneous or intravenous anticoagulant medications, such as oral vitamin K inhibitors for the last 7 days, non-vitamin K inhibitor oral anticoagulant (dabigatran, apixaban, rivaroxaban) for the last 72 hours. Intravenous or subcutaneous heparin-derived compounds for the last 48 hours. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Patterson
Phone
434-243-7336
Email
mwp5f@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Elias
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia UVA Health, University Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Patterson
Phone
434-243-7336
Email
mwp5f@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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