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New treatment option for Chronic Pain
Official title From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
ClinicalTrials.gov ID: NCT05661903
What this study is testing
What is Positron Emission Tomography / Magnetic Resonance Imaging?
Positron Emission Tomography / Magnetic Resonance Imaging is an investigational medicine, being studied as a potential treatment for chronic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Aged 18 to 80
- Capable of providing informed consent and following trial procedures, including capacity to complete self-reported measures of pain, function, and...
- 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
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility 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
- 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...
- 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...
- 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...
- people 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).
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.