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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    6
  • sponsor
    Jeff Elias, MD
Updated on 13 May 2022
opioid
cancer
carcinoma
squamous cell carcinoma
dental caries
neck cancer

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

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.

Details
Condition Cancer of Head and Neck, Pain, Face, Pain, Neck
Treatment ExAblate Neuro
Clinical Study IdentifierNCT03894553
SponsorJeff Elias, MD
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

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
Subjects who are able and willing to give consent and able to attend all study visits
The region of the mesencephalon must be apparent on MRI. Additional MRI
Subjects who are able to communicate sensations during the focused ultrasound treatment
sequences including inversion-recovery and DTI may be utilized to refine the
Stable prescribed doses of all symptomatic pain medications for 30 days prior to screening visit
target

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)
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
Subjects with active psychiatric illness will be excluded. For the purpose of this
received electroconvulsive therapy for depression
study, active psychiatric illness includes
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
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
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.)
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
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