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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California Los Angeles
RECRUITING
Los Angeles
Texas
University of Texas Southwestern Medical Center
NOT_YET_RECRUITING
Dallas
Contact Information
Primary
Meskereen Tolossa
MTolossa@mednet.ucla.edu
310-206-9187
Backup
Wendy Sia
Wsia@mednet.ucla.edu
3108255610
Time Frame
Start Date: 2021-05-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 16
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov