MRI-Guided Cryoablation to Alleviate Pain in Head, Neck and Spine
MRI-Guided Cryoablation of Head, Neck and Spine Nerves and Facets Using the Advanced Multimodality Image Guided Operating(AMIGO) Suite
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Thomas Lee, MD
- Phone Number: (617) 732-7260
- Email: tchlee@partners.org
Study Contact Backup
- Name: Danielle Chamberlain, BS, RT(R)
- Phone Number: 617-525-8596
- Email: dchamberlain1@partners.org
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham and Women's Hospital
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Contact:
- Thomas Lee, M.D.
- Phone Number: 617-732-7260
- Email: tchlee@partners.org
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Contact:
- Danielle Chamberlain, B.S, R.T.(R)
- Phone Number: 617-525-8596
- Email: dchamberlain1@partners.org
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Principal Investigator:
- Thomas C. Lee, M.D
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Cryoablation under image guidance
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).
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Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.
Other Names:
Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Eliminating radicular pain or pain caused by spinal disease.
Time Frame: 1 month
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We will be grading patients pain using the "Brief Pain Inventory" pre-ablation and 1 month post-ablation.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Long term radicular pain relief
Time Frame: 1 year
|
We are attempting to produce long-term pain relief through cryoablation.
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1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas C Lee, MD, Brigham and Women's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-P-002071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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