NCT05661903 From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
| NCT ID | NCT05661903 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-06-08 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 180 participants in total. It began in 2023-06-08 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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).
Contact & Investigator
Brian Wainger, MD PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05661903 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05661903 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05661903 currently recruiting?
Yes, NCT05661903 is actively recruiting participants. Contact the research team at BWAINGER@PARTNERS.ORG for enrollment information.
Where is the NCT05661903 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States, Boston, United States.
Who is sponsoring the NCT05661903 clinical trial?
NCT05661903 is sponsored by Massachusetts General Hospital. The principal investigator is Brian Wainger, MD PhD at Massachusetts General Hospital. The trial plans to enroll 180 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.