Actively Recruiting
From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
Led by Massachusetts General Hospital · Updated on 2025-06-27
180
Participants Needed
3
Research Sites
220 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80
- Able to provide informed consent and complete self-reported pain and function measures
- Have a stable spinal cord or dorsal root ganglion stimulator implanted
- Device used for back, leg, neck, or arm pain
- Device has a paresthesia-free setting
You will not qualify if you...
- Not on a stable opioid dose or on a dose greater than 100 MME/day within two months before enrollment, or unwilling to keep a stable dose during the study
- Unable to distinguish back or neck/arm pain from other pain types
- Systemic or psychiatric illness that interferes with participation
- Other factors preventing participation or tolerance of study procedures
- For imaging subset: device not 3 Tesla MRI compatible
- Contraindications to MRI or PET scanning (e.g., pacemaker, vascular clips, neurosurgery, prosthetic valves, claustrophobia)
- Pregnant or breastfeeding
- Low affinity binder phenotype based on genetic testing
- Recent or current use of benzodiazepines except alprazolam, clonazepam, or lorazepam
- Exceeded yearly radiation exposure limits
- Unable to safely participate or provide reliable data during imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
B
Brian Wainger, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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