MRI-guided cryoablation for pain relief in the head, neck, and spine
MRI-Guided Cryoablation of Head, Neck and Spine Nerves and Facets Using the Advanced Multimodality Image Guided Operating(AMIGO) Suite
This study is testing a new way to relieve pain in the head, neck, and spine by using a special technique that freezes pain-causing nerves to see if it works better than regular treatments for people with joint or nerve issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT01788410 on ClinicalTrials.gov |
What this trial studies
This study aims to alleviate pain in patients suffering from facet joint disease or nerve compression in the head and neck. It utilizes MRI-guided cryoablation, a minimally invasive technique that destroys pain-transmitting nerves to provide longer-lasting pain relief compared to traditional methods. The procedure is performed in the Advanced Multimodality Image Guided Operating Suite (AMIGO) at Brigham and Women's Hospital, which enhances precision and reduces risks associated with nerve ablation. Participants will undergo imaging and treatment to assess the efficacy of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates include adults with facet joint disease or pain from nerve compression who are suitable for minimally invasive procedures.
Not a fit: Patients with contraindications to MRI or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant and prolonged pain relief for patients with chronic pain conditions.
How similar studies have performed: Other studies have shown promising results with similar cryoablation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Thomas C Lee, MD — Brigham and Women's Hospital
- Study coordinator: Thomas Lee, MD
- Email: tchlee@partners.org
- Phone: (617) 732-7260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.