Can turning off a pain device reveal how it works?
NCT ID NCT05661903
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study investigates how spinal cord stimulation, a device implanted to treat chronic back, leg, neck, or arm pain, affects the nervous system. Adults with a stable implant will have their device turned on or off for two-week intervals, and some will undergo brain imaging. The goal is to understand the underlying mechanisms of pain relief, which could help refine future treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Spinal cord stimulation (turned on vs. off) and PET/MRI imaging
- What this could lead to
- If successful, this could reveal how spinal cord stimulation relieves chronic pain, potentially improving treatment protocols and patient selection.
- What could go wrong
- This is an early-stage mechanistic study, not a treatment trial. Results may not directly translate to better outcomes, and imaging is only in a subset of patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02215, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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