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From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
Sponsor: 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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2023-06-08
Completion Date
2027-08-31
Last Updated
2025-06-27
Healthy Volunteers
No
Conditions
Interventions
Spinal 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.
Usual Care
Patients in this intervention group will have their spinal cord stimulator turned on to their usual stimulation settings.
Positron 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 Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States