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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05661903
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Spinal Cord Stimulator Set to Minimal/No Stimulation Setting — OTHER
    Patients in this intervention group will have their spinal cord stimulator turned off or to the minimal settings possible.
  • Usual Care — OTHER
    Patients in this intervention group will have their spinal cord stimulator turned on to their usual stimulation settings.
  • Positron Emission Tomography / Magnetic Resonance Imaging — DRUG
    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.

Study Details

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 Dates

Start date
Jun 8, 2023
Status verified
Jun 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Other: Patients with Implanted Devices on Minimal/No Stimulation Settings
    Patients in this arm will be randomized to turn off their spinal cord stimulator (or to minimal settings).
  • Other: Patients with Implanted Devices on Usual Stimulation Settings
    Patients in this arm will be randomized to turn on their spinal cord stimulator to their usual stimulation settings.

Primary Outcome Measure

Supraexcitability [ Time Frame: From baseline (enrollment) to six weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Roy Freeman, MD
Brigham and Women's HospitalBostonMassachusetts02215
Christopher Gilligan, MD
Massachusetts General HospitalBostonMassachusetts02114
Brian Wainger, MD PhD
Marco Loggia, PhD (SUB_INVESTIGATOR)

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By research site
Beth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MAMassachusetts General Hospital· Boston, MA

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