Summary

Eligibility
for people ages 40-75 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Ausaf A. Bari, MD, PhD (ucla)
Headshot of Ausaf A. Bari
Ausaf A. Bari

Description

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.

Official Title

Deep Brain Stimulation of the Subgenual Cingulate Cortex for the Treatment of Medically Refractory Chronic Low Back Pain

Details

Chronic low back pain (CLBP) is one of the most ubiquitous and intractable problems in medicine and a significant source of patient suffering and disability, leading to opioid misuse and addiction. Previous neuromodulatory therapies for CLBP have focused primarily on spinal etiologies and intra-spinal mechanisms of pain transmission. However, existing pharmacological and neuromodulatory therapies have not been successful in treating CLBP. This project aims to address critical gaps and the unmet therapeutic needs of CLBP patients by using the Abbott Infinity DBS System; a next generation DBS device with directional steering capability implanted bilaterally in the subgenual cingulate cortex (SCC) to engage networks known to mediate the affective component of CLBP. The objective is to (1) Assess the preliminary efficacy of DBS of the SCC in the treatment of medically refractory CLBP; (2) Demonstrate the safety and feasibility of SCC DBS for CLBP; and (3) Develop diffusion tensor imaging (DTI)-based blueprints of response to SCC DBS for CLBP. The overall impact of this proof-of-concept pilot trial includes validation of the concept that suffering from CLBP results from pathological activity in affective brain networks, that these networks can be accurately engaged using a next-generation directional DBS device in a safe and feasible manner, and the discover of neuroimaging biomarkers of response to SCC DBS for CLBP.

Keywords

Chronic Low-back Pain, Back Pain, Low Back Pain, Deep Brain Stimulation of the Subgenus Cingulate Cortex

Eligibility

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90067 United States
  • University of Texas Southwestern Medical Center not yet accepting patients
    Dallas Texas 75390 United States

Lead Scientist at University of California Health

  • Ausaf A. Bari, MD, PhD (ucla)
    Associate Professor-in-Residence, Neurosurgery, Medicine. Authored (or co-authored) 63 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04085406
Study Type
Interventional
Participants
Expecting 16 study participants
Last Updated