[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100432286":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":63,"collaborators":25,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":68,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Rush University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DRG stimulation therapy at 20 Hz and 30 seconds ON, 90 seconds OFF","ACTIVE_COMPARATOR","DRG stimulation therapy at 20 Hz (30 seconds ON, 90 seconds OFF)",[13],"Device: DRG stimulation 20 Hz 30\u002F90",{"label":15,"type":10,"description":16,"interventionNames":17},"DRG stimulation therapy at 5 Hz and 30 seconds ON, 90 seconds OFF","DRG stimulation therapy at 5 Hz (30 seconds ON, 90 seconds OFF)",[18],"Device: DRG stimulation 5 Hz 30\u002F90",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","DRG stimulation 20 Hz 30\u002F90","Stimulation delivered at 20 Hz and 30 seconds ON, 90 seconds OFF",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"DRG stimulation 5 Hz 30\u002F90","Stimulation delivered at 5 Hz and 30 seconds ON, 90 seconds OFF",[15],[31],{"name":32,"affiliation":5,"role":33},"Robert McCarthy, PharmD","STUDY_DIRECTOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Sandeep Amin, MD","CONTACT","3129422966","sandeep_amin@rush.edu",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Daniel Torrez, BS","312-942-2741","Daniel_Torrez@rush.edu",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Chicago","Illinois","60612","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-87.65005,41.85003,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":61,"phoneExt":25,"email":62},"Robert J McCarthy","3125630448","Robert_J_McCarthy@rush.edu",{"type":64,"investigatorFullName":36,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Principal Investigator- Anesthesia Department (Provider)","100432286","intermittent-dosing-of-dorsal-root-ganglion-stimulation-as-an-alternate-paradigm-to-continuous-low-frequency-therapy-100432286",false,"NCT04909138","Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy","Inclusion Criteria:\n\n* Age between 18 and 99\n* 1-year or more use of continuous DRG therapy as delivered a permanently implanted Abbott PROCLAIM XR Dorsal Root Ganglion Neurostimulator System for chronic back and\u002For leg pain\n* Endorse at least 50% pain relief in the targeted area over the last year\n* Must have been seen for routine follow-up within last 4 months\n* Must have been reprogrammed in standard fashion at least once prior to randomization\n* Willing and able to complete protocol requirements, including:\n\n  * Complete health questionnaires and pain scales as specified in the protocol\n  * Sign the study-specific informed consent form\n  * Complete follow-ups at the designated time periods\n\nExclusion Criteria:\n\n* Significant lead migration, as determined by clinician\n* Other concurrent neuromodulation system in place\n* Corticosteroid injection in previous 30 days prior to enrollment\n* Intermittent dosing and\u002For failure within last 6m\n* Changing or unstable pain medications within 30 days","ALL","18 Years","90 Years",{"count":76,"type":77},30,"ESTIMATED","INTERVENTIONAL",[80],"NA","This study seeks to evaluate the use of intermittent dosing as an alternative paradigm for patients with DRG stimulation in place for at least 1 year and minimum 50% pain relief in the targeted area.\n\nPatients will be prospectively randomized to one of two stimulation paradigms both of which involve intermittent dosing at 30 seconds ON and 90 seconds OFF. Group 1 will have their frequency set at 20 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation). Group 2 will have their frequency set at 5 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation) This study will be performed in a crossover fashion, meaning patients will be changed to the alternate dosing regimen at the 13-week time period.\n\nPatients will be seen and evaluated prior to randomization and reprogramming, and thereafter evaluated at 4, 8, and 12-weeks. At the 12-week time period, patients will begin a 1-week washout period of continuous stimulation. At the 13-week time period, patients will be evaluated, crossed over to the other study arm and thereafter evaluated at 17, 21, and 25-weeks.",[83,84,85],"CRPS (Complex Regional Pain Syndromes)","Radiculopathy","Peripheral Neuropathy",[87,88],"Chronic Pain","Dorsal Root Ganglion Stimulation","2026-01-18",{"date":91,"type":92},"2026-01-21","ACTUAL",{"date":94,"type":92},"2022-10-15",{"date":96,"type":77},"2027-06",{"name":5,"class":6},1]