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

This study is currently recruiting participants.
Verified October 2017 by Thomas C. Lee, Brigham and Women's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01788410
First Posted: February 11, 2013
Last Update Posted: October 31, 2017
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.
Information provided by (Responsible Party):
Thomas C. Lee, Brigham and Women's Hospital
  Purpose
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.

Condition Intervention
Facet Joints; Degeneration Neuropathy Neuralgia Procedure: Cryoablation under image guidance Device: MRI Seednet Cryotherapy System (Galil Medical)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI-Guided Cryoablation of Head, Neck and Spine Nerves and Facets Using the Advanced Multimodality Image Guided Operating(AMIGO) Suite

Resource links provided by NLM:


Further study details as provided by Thomas C. Lee, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Eliminating radicular pain or pain caused by spinal disease. [ Time Frame: 1 month ]
    We will be grading patients pain using the "Brief Pain Inventory" pre-ablation and 1 month post-ablation.


Secondary Outcome Measures:
  • Long term radicular pain relief [ Time Frame: 1 year ]
    We are attempting to produce long-term pain relief through cryoablation.


Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
Procedure: Cryoablation under image guidance
Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.
Other Names:
  • MRI Seed Net Cryotherapy Unit (Galil Medical)
  • Siemens IMRIS
Device: MRI Seednet Cryotherapy System (Galil Medical)
Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.
Other Names:
  • FDA Approved
  • Cryoablation under image guidance

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Potential subjects must be 18 years of age and will be selected among patients who have a pain related to facet joint disease, nerve degeneration or compression. Subjects must benefit from a minimally invasive treatment option.
Criteria

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.
  Contacts and Locations
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): NCT01788410


Contacts
Contact: Thomas Lee, MD (617) 732-7260 tchlee@partners.org
Contact: Danielle Chamberlain, BS, RT(R) 617-525-8596 dchamberlain1@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Thomas Lee, M.D.    617-732-7260    tchlee@partners.org   
Contact: Danielle Chamberlain, B.S, R.T.(R)    617-525-8596    dchamberlain1@partners.org   
Principal Investigator: Thomas C. Lee, M.D         
Sub-Investigator: Srinivasan Mukundan, M.D., Ph.D.         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Thomas C Lee, MD Brigham and Women's Hospital
Study Chair: Srinivasan Mukundan, MD, PhD Brigham and Women's Hospital
  More Information

Additional Information:
Responsible Party: Thomas C. Lee, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01788410     History of Changes
Other Study ID Numbers: 2012-P-002071
First Submitted: February 7, 2013
First Posted: February 11, 2013
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Thomas C. Lee, Brigham and Women's Hospital:
Cryoablation
Nerves
Facet joint
Pain
Neuralgia
Neuropathy
Image-guided

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