Actively Recruiting
DBS of the SCC for the Treatment of Medically Refractory CLBP
Led by University of California, Los Angeles · Updated on 2025-07-10
16
Participants Needed
2
Research Sites
321 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the feasibility and preliminary efficacy of deep brain stimulation of the subgenual cingulate cortex for the treatment of chronic medically-refractory low back pain using a randomized double-blind crossover design.
CONDITIONS
Official Title
DBS of the SCC for the Treatment of Medically Refractory CLBP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pain due to failed back surgery syndrome with persistent low back pain despite prior surgeries
- Average back pain intensity greater than 8 out of 10 on the Visual Analog Scale for over 2 years
- Less than 50% pain relief from spinal cord stimulation trial or rejection/refusal of spinal cord stimulation
- Less than 50% pain relief from at least 4 weeks of physical therapy
- Less than 50% pain relief from at least 2 percutaneous spinal pain procedures
- Less than 50% pain relief from 3 months of opioid therapy (minimum 20 MEQ/day) or inability to tolerate opioid therapy due to side effects
- Less than 50% pain relief from 3-month trial of other pain medications besides opioids or inability to tolerate these medications due to side effects
- No surgically correctible cause for pain as confirmed by two independent neurosurgeons
- Age greater than 40 years
- Ability to provide informed consent and participate in 1.5-year follow-up visits including assessments and stimulator adjustments
- Willingness to share any unexpected neurological or psychiatric symptoms with study clinicians
You will not qualify if you...
- Significant neurocognitive impairment (MoCA score less than 26)
- Age over 75 years
- History of implant-related infection
- History of bleeding disorders or immune system compromise
- Psychiatric conditions other than depression or generalized anxiety disorder
- Neurological conditions reducing DBS response or increasing risk, including neurodegenerative diseases, severe movement disorders, demyelinating disorders, syringomyelia, epilepsy or seizures, CNS tumors, serious head injury with loss of consciousness, stroke, surgically reversible peripheral pain syndromes, and severe peripheral neuropathy
- Spine surgery within the last 3 months
- Major medical conditions increasing surgical risk such as uncontrolled hypertension, severe diabetes, major organ failure, hemorrhagic stroke history, need for chronic anticoagulation, active infection, immunocompromised state, or cancer with less than 5 years life expectancy
- Current spinal cord stimulator implant
- Life expectancy less than 1 year
- Current injury claim under litigation or approved/pending worker's compensation claim
- Living more than 100 miles from UCLA
- Recent suicide attempt or current suicide plan
- Alcohol or illicit substance use disorder in the last 6 months or unstable remission
- Uncontrolled medical conditions including cardiovascular problems and diabetes
- Pregnancy or planning pregnancy
- Use of blood thinners like warfarin
- Significant brain abnormalities seen on MRI
- Contraindications to MRI or need for repeated body MRIs
- Presence of implanted devices such as pacemakers, defibrillators, medication pumps, intracranial implants, or other stimulators
- Prior brain surgery
- Inability to stop therapeutic diathermy
- Participation in another clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of California Los Angeles
Los Angeles, California, United States, 90067
Actively Recruiting
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Not Yet Recruiting
Research Team
M
Meskereen Tolossa
CONTACT
W
Wendy Sia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here