From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
Massachusetts General Hospital
Summary
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.
Description
The fundamental hypothesis for this study is that spinal cord stimulators modulate the excitability of primary afferent neurons to reduce pain, and that these changes can be detected by measurement of axonal excitability. For the primary outcome, the study investigators will leverage the sensitivity and reproducibility of threshold tracking nerve conduction studies to detect changes in the excitability of thickly myelinated nerve fibers. The study investigators will use microneurography to record directly from primary nociceptive afferents. Finally, the study investigators will perform plasma…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Device with a paresthesia-free setting Exclusion Criteria: * 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 stab…
Interventions
- OtherSpinal Cord Stimulator Set to Minimal/No Stimulation Setting
Patients in this intervention group will have their spinal cord stimulator turned off or to the minimal settings possible.
- OtherUsual Care
Patients in this intervention group will have their spinal cord stimulator turned on to their usual stimulation settings.
- DrugPositron Emission Tomography / Magnetic Resonance Imaging
Patients with imaging compatible devices will undergo positron emission tomography/magnetic resonance imaging at three time points during the study. This imaging involves administration of the \[11C\]PBR28 radioligand, which is an investigational drug. Only a subset of patients who have 3 Tesla magnetic resonance imaging compatible stimulators will undergo this imaging.
Locations (3)
- Massachusetts General HospitalBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts