Safety Study Using Transcranial MR Guided Focused Ultrasound in the Treatment of Neuropathic Pain

Study Overview
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Brief Summary
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The aim of this study is to asses the efficacy and the clinical safety of the transcranial magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec Ltd. for functional neurosurgery. The treatments to be conducted in this study are non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will be used to evaluate the basic safety aspects of this new treatment technology and will serve as a basis for the clinical introduction of MR-guided ultrasound-neurosurgery.

Official Title
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MR-Guided Functional Ultrasound-Neurosurgery

Conditions
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Functional Brain Disorders /Neuropathic Pain

Intervention / Treatment
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* Device: ExAblate 4000 focused ultrasound brain intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients 18 years and older Clinical indication for a medial thalamotomy Stereotactic targets within thalamus, subthalamus and pallidum All targets supposedly accessible by TcMRgFUS Physically and mentally able to understand the risks of participating in this study and to give written informed consent based on the patient information provided Sufficient proficiency in one of the languages German, French, Italian or English to al-low for verbal communication during all phases of the study Physically and mentally able to communicate the personal condition and all feelings during the TcMRgFUS treatment Physically and mentally able to undergo the TcMRgFUS treatment Exclusion Criteria: Anomalies of brain anatomy, especially in or around thalamus or pallidum that will in-fluence the atlas-based navigation Existing lesions in close proximity (<5mm) to planned ablation targets Extended anomalies of scalp such as scars, inflammations, etc. Clips or other implanted objects close to (< 3cm) target Non-MRI-compatible cardiac pacemaker Previous hemorrhages in the brain Uncontrolled arterial hypertension Any coagulopathy or patient under anticoagulant therapy Sensitivity to MRI contrast agents Contraindications to MRI such as non-MRI-compatible implanted devices Large patients not fitting comfortably into the MRI unit (generally >110kg) Difficulty to lie supine and still for up to 4 hours in the MRI unit or claustrophobia Other known life-threatening systemic disease Patients currently participating or participated in another clinical trial in the last 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Trancranial MRg Focused Ultrasound for Neuropatic Pain<br> | Device: ExAblate 4000 focused ultrasound brain intervention<br>* Non-invasive brain intervention using MR-guided focused ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision of lesioning | Comparison of size and location of sonicaion lesions on MRI with planning coordinates. | 3 months | 
| Safety measurements | Number of Participants with Adverse Events as a Measure of Safety and Tolerability. | 6 months | 
| Lesion characteristics | Size of lesions as a function of applied energy/temperature. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Efficacy | Pain Scores on the Visual Analog Scale following intervention and at follow-up. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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focused ultrasound, functional brain disorders, neuropathic pain, movement disorders, FUS