Recruiting

DBS

Sponsor:

UCLA

Code:

NCT04085406

Conditions

Chronic Low-back Pain

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation of the Subgenus Cingulate Cortex

Study Details

Brief summary:

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

Chronic Low-back Pain

Study ID

NCT04085406

Start date

May 1, 2021

Status verified date

Jul, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Stimulation

Patients will be randomized in a 1:1 ratio to one of two groups: Active Treatment (active stimulation programmed to the settings found to be optimal during the initial open-label period) and a Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V).

sham comparator: Sham Stimulation

Patients will be randomized in a 1:1 ratio to one of two groups: Active Treatment (active stimulation programmed to the settings found to be optimal during the initial open-label phase) and a Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V).

Interventions

Deep Brain Stimulation of the Subgenus Cingulate Cortex

The Abbott Infinity DBS device will be surgically implanted in the bilateral subgenual cingulate cortex to provide electrical stimulation to this region.

Primary outcome measure

  • Change of at least 50% in pain scores on the visual analog scale (VAS) compared to baseline. [ Time Frame: 12 months - the end of the crossover period ]
  • Change in at least 50% in pain scores on the Pain Anxiety Symptoms Scale -- Short Form 20 (PASS SF-20) compared to baseline. [ Time Frame: 12 months - the end of the crossover period ]
  • At least 10% of study participants to experience one or more significant adverse events (SAEs) [ Time Frame: 18 months - the end of the study ]

Central Contacts and Locations

Central contacts

Meskereen Tolossa

310-206-9187MTolossa@mednet.ucla.edu

Wendy Sia

3108255610Wsia@mednet.ucla.edu

Locations

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90067

Contacts

Ausaf Bari

310-825-4321Barilab@mednet.ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jul 10, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-07-10.