Skip to main content
OpenTrials
Recruiting

NCT Number: NCT01788410

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Facet Joints; Degeneration Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathy Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cryoablation under image guidance

Procedure

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

MRI Seednet Cryotherapy System (Galil Medical)

Device

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

Primary outcomes

  1. 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 outcomes

  1. Long term radicular pain relief

    Time frame: 1 year

    We are attempting to produce long-term pain relief through cryoablation.

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Chamberlain, BS, RT(R)

CONTACT

[email protected]

617-525-8596

Thomas Lee, MD

CONTACT

[email protected]

(617) 732-7260

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2030
Study completion
2030
First posted
Feb 11, 2013
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.