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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309813
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
InSightec

Tracking Information
First Submitted Date  ICMJE October 5, 2017
First Posted Date  ICMJE October 16, 2017
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2017)
  • 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.
  • 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.
  • Positron Emission Tomography (PET) and Single-Photon Emission Computed Tomography (SPECT) [ Time Frame: PET and SPECT will be assessed before treatment and at 3 months following treatment. ]
    Functional imaging will serve as an objective measure to correlate with clinical pain assessments.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain
Official Title  ICMJE A Feasibility Study of Focused Ultrasound to Perform Bilateral Medial Thalamotomy for the Treatment of Chronic Trigeminal Neuropathic Pain
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Trigeminal Neuropathic Pain
Intervention  ICMJE
  • Device: Transcranial ExAblate
    ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain
    Other Names:
    • MRgFUS
    • Thalamotomy
  • Device: Sham Transcranial ExAblate
    Sham ExAblate Thalamotomy procedure
Study Arms  ICMJE
  • Experimental: Transcranial ExAblate
    ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS)
    Intervention: Device: Transcranial ExAblate
  • Sham Comparator: Sham Transcranial ExAblate
    ExAblate MRgFUS Sham Procedure
    Intervention: Device: Sham Transcranial ExAblate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matthew Patterson 434-243-7336 FUSbrain@virginia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03309813
Other Study ID Numbers  ICMJE NP002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William J Elias, MD University of Virginia
PRS Account InSightec
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP