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RECRUITING
NCT05661903
PHASE2

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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

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.

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