Deep Brain Stimulation for Chronic Lower Back Pain
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should not have an implanted spinal cord stimulator device and must be able to discontinue any existing therapeutic diathermy (a type of heat therapy).
What data supports the effectiveness of the treatment Deep Brain Stimulation for Chronic Lower Back Pain?
Deep Brain Stimulation (DBS) has shown success in treating chronic pain in selected patients, particularly those with pain after amputation, stroke, and other conditions. The subgenual cingulate cortex (SCC) is connected to brain areas involved in both chronic pain and depression, suggesting that DBS targeting this area could be effective for chronic lower back pain.12345
Is deep brain stimulation generally safe for humans?
Deep brain stimulation (DBS) has been shown to be safe in humans for treating movement disorders and chronic pain, with successful outcomes reported in selected patients over the past decade. Studies have been conducted in experienced centers, and while more research is needed, the existing data supports its safety in humans.12678
How is the treatment of Deep Brain Stimulation for Chronic Lower Back Pain different from other treatments?
Deep Brain Stimulation (DBS) for chronic lower back pain is unique because it targets the subgenual cingulate cortex, a brain area linked to both pain and depression, offering a novel approach by addressing the overlap between these conditions, unlike traditional pain treatments that may not consider this connection.12356
Research Team
Ausaf Bari, MD PhD
Principal Investigator
UCLA Department of Neurosurgery
Eligibility Criteria
This trial is for adults over 40 with severe chronic lower back pain that hasn't improved after surgery, physical therapy, spinal procedures, opioid or other pain medication trials. Candidates must have tried and not responded to spinal cord stimulation, be able to consent and follow up for 1.5 years, and live within 100 miles of UCLA. Exclusions include cognitive impairment, bleeding disorders, substance abuse issues in the last six months, uncontrolled medical conditions like heart disease or diabetes, pregnancy or planning to become pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Open-label Period
Participants receive active stimulation to determine optimal settings
Randomized Double-blind Crossover
Participants undergo active or sham stimulation in a crossover design
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Deep Brain Stimulation of the Subgenus Cingulate Cortex
Deep Brain Stimulation of the Subgenus Cingulate Cortex is already approved in United States, Canada, European Union for the following indications:
- Treatment-resistant depression
- Obsessive-compulsive disorder
- Treatment-resistant depression
- Treatment-resistant depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator