DBS of the SCC for the Treatment of Medically Refractory CLBP

NCT04085406 | Recruiting DMC FDA Device

• 1 other identifier: UH3NS113661
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Change of at least 50% in pain scores on the visual analog scale (VAS) compared to baseline.

  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.

  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.

  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.

  12 months - the end of the crossover period

• At least 10% of study participants to experience one or more significant adverse events (SAEs)

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

  18 months - the end of the study

Secondary Outcomes (17)

• Change in dose and/or frequency of opioid analgesic medication use in oral morphine equivalents.

  12 months - the end of the crossover period

• 50% improvement in McGill Pain Questionnaire (MPQ)

  12 months - the end of the crossover period

• Change in Short-Form 36 (SF-36) quality of life questionnaire score.

  12 months - the end of the crossover period

• Change in EuroQol 5-Domain (EQ-5D) Score

  12 months - the end of the crossover period

• Change in Montreal Cognitive Assessment Score (MoCA)

  12 months - the end of the crossover period

Study Arms (2)

Active Stimulation

EXPERIMENTAL

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).

Device: Deep Brain Stimulation of the Subgenus Cingulate Cortex

Sham Stimulation

SHAM COMPARATOR

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).

Device: Deep Brain Stimulation of the Subgenus Cingulate Cortex

Interventions

Deep Brain Stimulation of the Subgenus Cingulate Cortex DEVICE

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

Active Stimulation; Sham Stimulation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

University of California Los Angeles

Los Angeles, California, 90067, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

NOT YET RECRUITING

Study Officials

• Ausaf Bari, MD PhD

  UCLA Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meskereen Tolossa

CONTACT

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

Wendy Sia

CONTACT

3108255610; Wsia@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 11, 2019
• Study Start: May 1, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)