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Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT03309813
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
InSightec

Brief Summary:
The goal of this prospective, randomized, sham-controlled, crossover study is to evaluate the safety and feasibility of ExAblate Neuro treatment of chronic trigeminal neuropathic pain.

Condition or disease Intervention/treatment Phase
Trigeminal Neuropathic Pain Device: Transcranial ExAblate Device: Sham Transcranial ExAblate Not Applicable

Detailed Description:
This study is to show that for patients with treatment-refractory chronic trigeminal neuropathic pain, ExAblate Neuro focused ultrasound (FUS) can safely create lesions bilaterally in the thalamic nuclei to reduce pain and provide functional benefits in daily activities. After informed consent and screening, eligible subjects will be randomized to either an ExAblate treatment or a Sham Control procedure. Subjects who are randomized to Sham Control will undergo the same procedure and follow-up visits through their Month 3 visit. After the Month 3 assessments are complete, all subjects will be un-blinded and those in the Sham treated group will have the option for an actual ExAblate treatment in an un-blinded fashion, as long as they still qualify for ExAblate treatment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Feasibility Study of Focused Ultrasound to Perform Bilateral Medial Thalamotomy for the Treatment of Chronic Trigeminal Neuropathic Pain
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Transcranial ExAblate
ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS)
Device: Transcranial ExAblate
ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain
Other Names:
  • MRgFUS
  • Thalamotomy

Sham Comparator: Sham Transcranial ExAblate
ExAblate MRgFUS Sham Procedure
Device: Sham Transcranial ExAblate
Sham ExAblate Thalamotomy procedure




Primary Outcome Measures :
  1. Severity of Device and Procedure related complications [ Time Frame: At the time of ExAblate Transcranial thalamotomy procedure. ]
    To evaluate the incidence and severity of adverse events associated with ExAblate lesioning of the bilateral medial thalamus for painful neuropathies of the face and head that are severe and treatment-refractory.

  2. Numeric Pain Rating Scale (NPRS) [ Time Frame: Change in NPRS from before treatment to 3 Months following treatment. ]
    To compare the change in worst pain experienced over 24 hours before and at 3 months following bilateral FUS medial thalamotomy versus sham procedures as determined from the 11-point numeric pain rating scale.


Secondary Outcome Measures :
  1. Patient Global Impression of Change (PGIC) [ Time Frame: PGIC will be assessed 7 days, 1 month, and 3 months following treatment. ]
    To assess the patient-reported change in activity, limitations, symptoms, emotions, and overall quality of life following treatment.

  2. Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory [ Time Frame: PROMIS pain inventory will be assessed before treatment and at 1 day, 7 days, 1 month, and 3 months following treatment. ]
    To assess the patient-reported PROMIS pain domain questionnaires for pain intensity, quality, behavior, and interference.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, between 18 and 75 years, inclusive
  • Subjects who are able and willing to give consent and able to attend all study visits
  • Severe chronic, trigeminal neuropathic pain of ≥6 months duration.
  • Pain is medication-refractory to adequate trials of at least 3 prescription medications commonly used for symptomatic relief of neuropathic pain with current adjunctive use of at least one medication. An adequate medication trial is defined as a therapeutic dose of each medication without sufficient effect.
  • Pain is treatment-resistant to at least one interventional therapies including injections, procedures, neuromodulation, and surgery.
  • Able to communicate sensations during the focused ultrasound treatment
  • Stable prescribed doses of all symptomatic pain medications for 30 days prior to study entry and for the duration of the 3-month blinded phase of the study.

Exclusion Criteria:

  • Craniofacial pain syndromes related to malignancy of the head and neck
  • Idiopathic trigeminal neuralgia
  • Headache syndromes like migraine, cluster headache
  • Temporomandibular joint syndrome
  • Atypical facial pain or pain related to a somatoform disorder
  • 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 will be excluded.
  • 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.
  • Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
  • 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
  • Presence of systemic neurological disease or dysfunction
  • Known life-threatening systemic disease
  • Subjects with brain tumors or any significant intracranial mass. Trigeminal or cavernous sinus tumors causing neuropathic pain are not excluded.
  • Pregnancy or lactation
  • Legal incapacity or limited legal capacity
  • Subjects with a deep brain stimulation implant or with a prior stereotactic thalamic ablation
  • History of hemorrhagic stroke or cerebrovascular event within the past year of treatment exhibiting incomplete resolution
  • History of seizures within past year of treatment
  • Severe kidney disease or on dialysis
  • Subjects who are unable to tolerate medications due to intolerable side effects.
  • Subjects with pain other than craniofacial neuropathic pain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309813


Contacts
Contact: Matthew Patterson 434-243-7336 FUSbrain@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Matthew Patterson    434-982-6455    FUSbrain@virginia.edu   
Principal Investigator: William Jeff Elias, MD         
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: William J Elias, MD University of Virginia

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03309813     History of Changes
Other Study ID Numbers: NP002
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by InSightec:
ExAblate
TcMRgFUS
Thalamotomy

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms