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From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects

RecruitingPhase 2NCT05661903
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects
Conditions
Interventions
  • Other: Spinal Cord Stimulator Set to Minimal/No Stimulation Setting
  • Other: Usual Care
  • Drug: Positron Emission Tomography / Magnetic Resonance Imaging
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Start date
2023-06-08
Primary completion
2027-08-31
Sex
All
Age range
from 18 Years to 80 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
3

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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).

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05661903