DBS of the SCC for the Treatment of Medically Refractory CLBP (NCT04085406)

🧪 Interventions in This Study

• Deep Brain Stimulation of the Subgenus Cingulate Cortex (DEVICE)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Pain secondary to failed back surgery syndrome (FBSS) as defined by persistent low back pain despite prior surgical interventions.
2. Self-reported average back pain intensity of greater than 8 out of 10 on the Visual Analog Scale (VAS) documented over greater than 2 years.
3. Failure to achieve at least 50% pain relief from a trial of spinal cord stimulation (SCS) or less than 50% pain relief after 3 months of SCS therapy or patient refuses/rejects SCS trial
4. Failure to achieve at least 50% pain relief in response to at least 4 weeks of physical therapy.
5. Failure to achieve at least 50% pain relief in response to at least 2 percutaneous spinal pain procedures.
6. Failure to achieve at least 50% pain relief in response to 3 months of opioid therapy (at least 20 MEQ/day) or inability to increase or tolerate opioid therapy due to dose-limiting side effects).
7. Failure to achieve at least 50% pain relief in response to a 3-month trial of at least one other class of pain medication in addition to opioid therapy or inability to tolerate increasing doses of non-opioid pain medications due to dose-limiting side effects.
8. Lack of a surgically correctible etiology for the pain as determined by 2 independent neurosurgeons
9. Age greater than 40 years of age.
10. Ability to give informed consent in accordance with institutional policies and participate in the 1.5-year follow-up, involving assessments and stimulator adjustments.
11. Willingness to share unexpected neurological or psychiatric symptoms with study clinicians.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

• University of California Los Angeles — Los Angeles, California
• University of Texas Southwestern Medical Center — Dallas, Texas

📞 Contact the Study Coordinator

Phone: (310) 206-9187

Email: MTolossa@mednet.ucla.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Chronic Low-back Pain

• Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain — Aventura, Florida
• Psilocybin Therapy for Chronic Low Back Pain — San Francisco, California
• Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain — San Francisco, California
• Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain — Kansas City, Kansas
• Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management. — Kansas City, Kansas
• Psilocybin in Chronic Low Back Pain and Depression — Baltimore, Maryland

Explore by condition: All Chronic Low-back Pain clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.