[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490113":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":38,"locations":43,"responsibleParty":79,"collaborators":82,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":24,"eligibilityCriteria":91,"healthyVolunteers":88,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":24,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":24,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"Patients with Implanted Devices on Minimal\u002FNo Stimulation Settings","Patients in this arm will be randomized to turn off their spinal cord stimulator (or to minimal settings).",[12,13],"Other: Spinal Cord Stimulator Set to Minimal\u002FNo Stimulation Setting","Drug: Positron Emission Tomography \u002F Magnetic Resonance Imaging",{"label":15,"type":6,"description":16,"interventionNames":17},"Patients with Implanted Devices on Usual Stimulation Settings","Patients in this arm will be randomized to turn on their spinal cord stimulator to their usual stimulation settings.",[18,13],"Other: Usual Care",[20,25,29],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Spinal Cord Stimulator Set to Minimal\u002FNo Stimulation Setting","Patients in this intervention group will have their spinal cord stimulator turned off or to the minimal settings possible.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Usual Care","Patients in this intervention group will have their spinal cord stimulator turned on to their usual stimulation settings.",[15],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":24},"DRUG","Positron Emission Tomography \u002F Magnetic Resonance Imaging","Patients with imaging compatible devices will undergo positron emission tomography\u002Fmagnetic 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.",[9,15],[35],{"name":36,"affiliation":5,"role":37},"Brian Wainger, MD PhD","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":24,"email":42},"CONTACT","617-726-8810","BWAINGER@PARTNERS.ORG",[44,62,71],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-71.05977,42.35843,{"lat":55,"lon":54},[58,59],{"name":36,"role":40,"phone":24,"phoneExt":24,"email":24},{"name":60,"role":61,"phone":24,"phoneExt":24,"email":24},"Marco Loggia, PhD","SUB_INVESTIGATOR",{"facility":63,"status":45,"city":46,"state":47,"zip":64,"country":49,"countryCode":50,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"Beth Israel Deaconess Medical Center","02215",{"type":52,"coordinates":66},[54,55],{"lat":55,"lon":54},[69],{"name":70,"role":40,"phone":24,"phoneExt":24,"email":24},"Roy Freeman, MD",{"facility":72,"status":45,"city":46,"state":47,"zip":64,"country":49,"countryCode":50,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Brigham and Women's Hospital",{"type":52,"coordinates":74},[54,55],{"lat":55,"lon":54},[77],{"name":78,"role":40,"phone":24,"phoneExt":24,"email":24},"Christopher Gilligan, MD",{"type":37,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Brian Wainger","Assistant Professor in Anesthesiology and Neurology",[83],{"name":84,"class":85},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH","100490113","phase-2-from-nerve-to-brain-toward-a-mechanistic-understanding-of-spinal-cord-stimulation-in-human-subjects-100490113",false,"NCT05661903","From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects","Inclusion Criteria:\n\n* Aged 18 to 80\n* Capable of providing informed consent and following trial procedures, including capacity to complete self-reported measures of pain, function, and other outcomes\n* Stably implanted spinal cord or dorsal root ganglion stimulator\n* Device is to treat back\u002Fradicular lower extremity pain or neck\u002Farm pain\n* Device with a paresthesia-free setting\n\nExclusion Criteria:\n\n* Patients who are not on a stable dose of opioids or are on a stable dose greater than 100 MME\u002Fday 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\n* The investigator concludes that the participant is unable to differentiate back or neck\u002Farm pain from other pains\n* Systemic or psychiatric illness that in the opinion of the site investigator would interfere with the individual's ability to participate in the trial\n* 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\n\nDropout Criteria for Optional Imaging\n\n* Stimulation device is not 3 Tesla magnetic resonance imaging compliant\n* Contraindications to magnetic resonance imaging and\u002For 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)\n* Pregnant or breastfeeding\n* Participants with a low affinity binder phenotype based off testing for the Ala147Thr polymorphism.\n* 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.\n* 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\n* In the opinion of the investigators, unable to safely participate in this study and\u002For provide reliable data (e.g., unlikely to remain still during the imaging procedures).","ALL","18 Years","80 Years",{"count":96,"type":97},180,"ESTIMATED","INTERVENTIONAL",[100],"PHASE2","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\u002Fmagnetic resonance imaging at baseline, week 2 and week 4.",[103],"Chronic Pain","2026-08-18",{"date":106,"type":107},"2026-08-20","ACTUAL",{"date":109,"type":107},"2023-06-08",{"date":111,"type":97},"2027-08-31",{"name":5,"class":6},3]