NCT05661903 · Massachusetts General Hospital
From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
What this study is about
This is a conducted at multiple hospitals forward-looking 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.
View original scientific description
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.
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.
Primary outcome measures
Supraexcitability
Time frame: From baseline (enrollment) to six weeks
The primary outcome will be superexcitability (indicating paired pulse facilitation) measured by threshold tracking nerve conduction.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 27, 2025 · Source of record for eligibility and locations