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New treatment option for Chronic Low-back Pain
Official title DBS of the SCC for the Treatment of Medically Refractory CLBP
ClinicalTrials.gov ID: NCT04085406
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
See the full eligibility 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...
- 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.
- 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...
- Patients who have undergone spine surgery within the previous 3 months.
- Major medical co-morbidities increasing the risk of surgery including uncontrolled hypertension, severe diabetes, major organ system failure, history of hemorrhagic stroke, need for chronic anticoagulation, active...
- Individuals with a currently implanted SCS device.
- Individuals with a life expectancy less than 1 year due to any cause.
- Individuals involved in an injury claim under current litigation.
- Individuals with a pending or approved worker's compensation claim.
- Patient living greater than 100 miles from UCLA.
- Suicide attempt in the last two years and/or presence of a suicide plan (an answer of Yes to Question C4 in Section C- Suicidality of MINI International Neuropsychiatric Interview).
- Alcohol or illicit substance use disorder (other than nicotine) within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of...
- Uncontrolled medical condition including cardiovascular problems and diabetes.
- Pregnant or planning to become pregnant.
- Use of warfarin or other blood thinners.
- Significant structural abnormality on preoperative brain MRI.
- Contraindications to MRIs or the need for recurrent body MRIs.
- Presence of cardiac pacemakers/defibrillators, implanted medication pumps, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulators.
- History of prior cranial neurosurgery.
- Patients unable to discontinue any existing therapeutic diathermy.
- Individuals who are concomitantly participating in another clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Dallas, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.