Recruiting
Phase 2

Spinal Cord Stimulation

Sponsor:

Massachusetts General Hospital

Code:

NCT05661903

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Spinal Cord Stimulator Set to Minimal/No Stimulation Setting

Usual Care

Positron Emission Tomography / Magnetic Resonance Imaging

Study Details

Brief 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.

Conditions

Chronic Pain

Study ID

NCT05661903

Start date

Jun 8, 2023

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 18 to 80
  • Capable of providing informed consent and following trial procedures, including capacity to complete self-reported measures of pain, function, and other outcomes
  • Stably implanted spinal cord or dorsal root ganglion stimulator
  • Device is to treat back/radicular lower extremity pain or neck/arm pain
  • Device with a paresthesia-free setting

Exclusion Criteria:

  • Patients who are not on a stable dose of opioids or are on a stable dose greater than 100 MME/day per day within the two months prior to enrollment, or those who are unwilling to maintain a stable dose of opioids throughout the duration of the study
  • The investigator concludes that the participant is unable to differentiate back or neck/arm pain from other pains
  • Systemic or psychiatric illness that in the opinion of the site investigator would interfere with the individual's ability to participate in the trial
  • Other factor that in the opinion of the site investigator would interfere with the individual's ability to participate in the trial or tolerate the study procedures

Dropout Criteria for Optional Imaging

  • Stimulation device is not 3 Tesla magnetic resonance imaging compliant
  • Contraindications to magnetic resonance imaging and/or positron emission tomography scanning (including presence of a cardiac pacemaker or pacemaker wires, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia)
  • Pregnant or breastfeeding
  • Participants with a low affinity binder phenotype based off testing for the Ala147Thr polymorphism.
  • Current or recent use of benzodiazepines (except for alprazolam, clonazepam, and lorazepam). Recent use will be defined based off the benzodiazepines half-life, such that patients who stopped taking the medication at least five half-lives ago will be considered eligible for scanning.
  • Subjects who have exceeded (or would exceed if they were to participate) the yearly amount of allowable radiation, as defined by the Radiation Safety Committee
  • In the opinion of the investigators, unable to safely participate in this study and/or provide reliable data (e.g., unlikely to remain still during the imaging procedures).

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Brian Wainger, MD PhD

617-726-8810BWAINGER@PARTNERS.ORG

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-08-20.