Understanding how spinal cord stimulation affects chronic pain
From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
This study is testing how turning spinal cord stimulators on and off affects chronic pain in patients who already have these devices implanted.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT05661903 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective study investigates the effects of spinal cord stimulators on chronic pain in patients with stably implanted devices. Participants will be randomly assigned to alternate between turning their stimulators on and off for two-week intervals, allowing researchers to assess changes in pain levels and nerve excitability. The study will utilize advanced techniques such as microneurography and imaging to explore the mechanistic effects of spinal cord stimulation on pain modulation. By correlating these physiological changes with patient-reported outcomes, the study aims to identify relevant mechanisms of pain relief.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a stably implanted spinal cord or dorsal root ganglion stimulator for back or neck pain.
Not a fit: Patients with unstable opioid dosages or those unable to differentiate their pain types may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and optimization of spinal cord stimulation therapies for chronic pain management.
How similar studies have performed: Previous studies have shown promise in understanding spinal cord stimulation effects, but this study employs novel methodologies to deepen mechanistic insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Boston, Massachusetts and 2 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Brian Wainger, MD PhD — Massachusetts General Hospital
- Study coordinator: Brian Wainger, MD PhD
- Email: BWAINGER@PARTNERS.ORG
- Phone: 617-726-8810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.