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

Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01788410
• Other study ID #: 2012-P-002071
• Status: Recruiting
• Start date: May 2013
• Est. completion date: May 2030

Study information

• Verified date: August 2023
• Source: Brigham and Women's Hospital
• Contact: Thomas Lee, MD
• Phone: (617) 732-7260
• Email: tchlee[@]partners.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2030
• Est. primary completion date: May 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Facet Joints; Degeneration
• Neuralgia
• Neuropathy

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eliminating radicular pain or pain caused by spinal disease.	We will be grading patients pain using the "Brief Pain Inventory" pre-ablation and 1 month post-ablation.	1 month
Secondary	Long term radicular pain relief	We are attempting to produce long-term pain relief through cryoablation.	1 year

External Links

•   AMIGO Operating Suite, Brigham and Women's Hospital (BWH)
•   Brigham and Women's Hospital Tumor Ablation Program