NCT01788410

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Facet Joints; Degeneration
• Neuropathy
• Neuralgia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2030-05-01
• Completion: 2030-05-01
• First posted: 2013-02-11
• Last updated: 2023-08-08

Locations

1 site across 1 country: United States