From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects

This is a multicenter prospective study in two patient cohorts, namely patients who currently have stably implanted spinal cord simulators. Patients will be randomly assigned to turn on or off their spinal cord stimulators for two week intervals up to six weeks after enrollment, and on the final day of study participation, for two hour intervals, in a multi-crossover design.

Inclusion Criteria:Aged 18 to 80Capable of providing informed consent and following trial procedures, including capacity to complete self-reported measures of pain, function, and other outcomesStably implanted spinal cord or dorsal root ganglion stimulatorDevice is to treat failed back surgery syndrome with back and radicular lower extremity painDevice with a paresthesia-free settingExclusion Criteria:Patients who are not on a stable dose of opioids or are on a stable dose greater than 100 morphine equivalents/day per day within the two months prior to enrollment, or those who are unwilling to maintain a stable dose of opioids throughout the duration of the studyThe investigator concludes that the participant is unable to differentiate failed back surgery syndrome pain from other pains, or the primary cause of pain is unrelated to failed back surgery syndrome.Systemic or psychiatric illness that in the opinion of the site investigator would interfere with the individual's ability to participate in the trialOther factor that in the opinion of the site investigator would interfere with the individual's ability to participate in the trial or tolerate the study procedures