DBS of the SCC for the Treatment of Medically Refractory CLBP
RecruitingNot applicableNCT04085406
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Deep Brain Stimulation of the Subgenual Cingulate Cortex for the Treatment of Medically Refractory Chronic Low Back Pain
- Conditions
- Interventions
- Device: Deep Brain Stimulation of the Subgenus Cingulate Cortex
- Sponsor
- University of California, Los Angeles
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Start date
- 2021-05-01
- Primary completion
- 2027-06-30
- Sex
- All
- Age range
- from 40 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Pain secondary to failed back surgery syndrome (FBSS) as defined by persistent low back pain despite prior surgical interventions. * 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. * 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 * Failure to achieve at least 50% pain relief in response to at least 4 weeks of physical therapy. * Failure to achieve at least 50% pain relief in response to at least 2 percutaneous spinal pain procedures. * 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). * 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. * Lack of a surgically correctible etiology for the pain as determined by 2 independent neurosurgeons * Age greater than 40 years of age. * Ability to give informed consent in accordance with institutional policies and participate in the 1.5-year follow-up, involving assessments and stimulator adjustments. * Willingness to share unexpected neurological or psychiatric symptoms with study clinicians. Exclusion Criteria: * Significant neurocognitive impairment (MoCA \< 26). * Age \> 75 years. * History of implant-related infection. * History of bleeding disorder or immune-compromise. * Psychiatric comorbidity other than depression or generalized anxiety disorder, as determined by MINI International Neuropsychiatric Interview. * Patients with neurological diagnoses that may reduce the response to or increase the risk of DBS including neurodegenerative conditions, severe movement disorders, demyelinating disorders, syringomyelia, epilepsy or history of seizures, history of CNS tumors (spinal and/or cranial), history of serious head injury with loss of consciousness, history of stroke, surgically reversible peripheral pain syndromes including surgically correctable radiculopathy, and severe peripheral neuropathy. * Patients who have undergone spine surgery within the previous 3 months. * Major medical co-morbidities increasing the r…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04085406