MRI-Guided Cryoablation to Alleviate Pain in Head, Neck and Spine

Study Overview
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Brief Summary
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The objective of this study is to provide pain relief to patients with facet joint disease or head and neck pain related to compression of a nerve root. The goal is to provide palliative care with superior efficacy and longer relief compared to current methods.

Detailed Description
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Nerve ablation is used therapeutically to produce temporary anesthesia and diagnostically to locate the source of pain. Ablation, or purposeful destruction of tissue, relieves facet joint pain and pain related to nerve damage by disabling pain-transmitting nerves. Cryoablation for pain management is particularly useful when other modalities are too difficult to perform or have a high incidence for complications or side effects. Currently nerve ablation is performed with bupivacaine and alcohol, but MRI-guided cryoablation of nerves and facets may result in superior efficacy and longer relief. Cryotherapy techniques provide long term analgesia and help alleviate intractable pain for patients with facet joint pain and neuralgia. Minimally invasive Magnetic Resonance (MR)-guided ablation of nerves and facets may lead to decreased procedure time and increased relief of pain due to cancer or nerve degeneration. With the advent of the Advanced Multimodality Image Guided Operating Suite (AMIGO) at the Brigham and Women's Hospital, we have exceptional capabilities for minimally invasive image-guided procedures, including different ablation techniques. The AMIGO suite is equipped with hardware that will keep the patient stationary while the Magnetic Resonance Imaging scanner moves to the patient. Additionally, the monitoring software within the AMIGO suite allows clinicians to instantaneously analyze the imaging information which significantly reduces the risk of injury to adjacent structures.

Official Title
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MRI-Guided Cryoablation of Head, Neck and Spine Nerves and Facets Using the Advanced Multimodality Image Guided Operating(AMIGO) Suite

Conditions
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Facet Joints; Degeneration, Neuropathy, Neuralgia

Intervention / Treatment
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* Procedure: Cryoablation under image guidance
* Device: MRI Seednet Cryotherapy System (Galil Medical)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be willing and able to sign a written informed consent document. Patients must have facet joint disease or pain due to a damaged or compressed nerve that would benefit from a minimally invasive image-guided procedure (i.e., adjacent to critical structures, better visualized under 3 Tesla MRI than CT) Subjects must be able to adhere to the visit schedules and attend pre and post imaging. Participants must be at least 18 years of age Participants must have an estimated life expectancy of >8 weeks in the opinion of the clinician. Patients with radiculopathy must have the cause of pain confirmed by a nerve block within 3 months prior to ablation Exclusion Criteria: Contraindications to MRI and Gadolinium- (i.e. estimated Glomerular Filtration Rate <60ml/min, metal clips) Pregnant or breastfeeding woman are excluded from this research.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cryoablation under image guidance<br>Patients with facet joint disease, or compressed or damaged nerve roots causing pain in the head, neck or spine. Procedures performed with MRI Seednet Cryotherapy System (Galil Medical). | Procedure: Cryoablation under image guidance<br>* Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.<br>* Other names: Siemens IMRIS;Device: MRI Seednet Cryotherapy System (Galil Medical)<br>* Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.<br>* Other names: Cryoablation under image guidance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eliminating radicular pain or pain caused by spinal disease. | We will be grading patients pain using the Brief Pain Inventory pre-ablation and 1 month post-ablation. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term radicular pain relief | We are attempting to produce long-term pain relief through cryoablation. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryoablation, Nerves, Facet joint, Pain, Neuralgia, Neuropathy, Image-guided