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

Recruiting

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

• Registration Number: NCT01788410
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Study Start: 2013-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08
• Primary Completion: 2030-05
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cryoablation under image guidance	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).
Cryoablation under image guidance	MRI Seednet Cryotherapy System (Galil Medical)	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).

Primary Outcome Measures

Name	Time	Method
Eliminating radicular pain or pain caused by spinal disease.	1 month	We will be grading patients pain using the "Brief Pain Inventory" pre-ablation and 1 month post-ablation.

Secondary Outcome Measures

Name	Time	Method
Long term radicular pain relief	1 year	We are attempting to produce long-term pain relief through cryoablation.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States