This is a multicenter prospective study of 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 one hour intervals, in a multi-crossover design. In a subset of patients we will also perform combined positron emission tomography/magnetic resonance imaging at baseline, week 2 and week 4.
Aged 18 to 80
Capable of providing informed consent and following trial procedures, including capacity to complete self-reported measures of pain, function, and other outcomes
Stably implanted spinal cord or dorsal root ganglion stimulator
Device is to treat back/radicular lower extremity pain or neck/arm pain
Patients who are not on a stable dose of opioids or are on a stable dose greater than 100 MME/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 study
The investigator concludes that the participant is unable to differentiate back or neck/arm pain from other pains
Systemic or psychiatric illness that in the opinion of the site investigator would interfere with the individual's ability to participate in the trial
Other 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
Massachusetts General Hospital
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator