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

PHASE2RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

June 8, 2023

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
Chronic Pain
Interventions
OTHER

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.

OTHER

Usual Care

Patients in this intervention group will have their spinal cord stimulator turned on to their usual stimulation settings.

DRUG

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.

Trial Locations (3)

02114

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

RECRUITING

Brigham and Women's Hospital, Boston

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

Massachusetts General Hospital

OTHER