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DBS for Chronic Low-back Pain

This study is testing a treatment called Deep Brain Stimulation (DBS) of the Subgenual Cingulate Cortex for people with chronic low-back pain that hasn't improved with other treatments. The Abbott Infinity DBS device will be surgically placed in your brain to deliver electrical stimulation. The study aims to see if this treatment can reduce your pain by at least 50% on a pain scale and a pain anxiety scale after 12 months. Researchers will also be looking for any significant side effects over 18 months. You may be able to join if you are between 40 and 75 years old, have had back pain for over two years, and your pain is rated higher than 8 out of 10, even after previous back surgeries. The current recruitment status is unclear, and the study plans to enroll 16 participants.

Study design
This is an interventional study with a randomized double-blind crossover design, meaning some participants will receive the treatment and others a placebo, and then switch. It plans to enroll 16 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 18 months after the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04085406

DBS of the SCC for the Treatment of Medically Refractory CLBP

Recruiting
NAAges 40–75InterventionalTreatment
University of California, Los Angeles
~16 participants
Updated 2025-07-10 on ClinicalTrials.gov
What's tested:Deep Brain Stimulation of the Subgenus Cingulate Cortex

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change of at least 50% in pain scores on the visual analog scale (VAS) compared to baseline.
Measured over 12 months - the end of the crossover period
+2 more outcomes measured

Conditions

Chronic Low-back Pain

Explore related trials

Chronic low back pain

Where it's being run

2 sites across 2 states
California1
Texas1

Study leadership

  • Ausaf Bari, MD PhD · PRINCIPAL_INVESTIGATOR · UCLA Department of Neurosurgery

Who to contact

Meskereen Tolossa
[email protected]
310-206-9187
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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 risk of surgery including uncontrolled hypertension, severe diabetes, major organ system failure, history of hemorrhagic stroke, need for chronic anticoagulation, active infection, immunocompromised state or malignancy with \< 5 years life expectancy.
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 treatment response.
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.

What this trial measures

  • Change of at least 50% in pain scores on the visual analog scale (VAS) compared to baseline.12 months - the end of the crossover period

    The visual analog scale for pain is a continuous horizontal scale of length 100 mm with the extremes of pain expressed on either end (0 = no pain, 10 = worst pain). The change on the VAS from active stimulation compared to baseline and sham stimulation will be calculated.

  • Change in at least 50% in pain scores on the Pain Anxiety Symptoms Scale -- Short Form 20 (PASS SF-20) compared to baseline.12 months - the end of the crossover period

    The PASS SF-20 score is a composite 20 item score which focuses on fear and anxiety of pain. It includes 4 sections on aspects of pain including cognitive, escape/avoidance, fear and physiological anxiety. All items are rated on a scale from 0 (never) to 5 (always), where higher values indicate worse outcome. Summary scores are calculated by summing assigned items and then by summing the subscales to derive an overall score for a possible total of 100. The change on the PASS from active stimulation compared to baseline and sham stimulation will be calculated.

  • At least 10% of study participants to experience one or more significant adverse events (SAEs)18 months - the end of the study

    The percentage of subjects with one or more SAEs during the entire study period will be calculated.