[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538200":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":65,"collaborators":68,"id":75,"slug":11,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":11,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":11,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":11,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Ohio State University","OTHER",[8,12,17],{"label":9,"type":10,"description":11,"interventionNames":11},"Conventional Medical Management (CMM). Group1","NO_INTERVENTION",null,{"label":13,"type":14,"description":11,"interventionNames":15},"Spinal Cord Stimulator (SCS) immediate activation. Group 2","ACTIVE_COMPARATOR",[16],"Device: Spinal Cord Stimulator Implantation (SCS)",{"label":18,"type":14,"description":11,"interventionNames":19},"Spinal Cord Stimulator (SCS) Delayed activation. Group 3",[16],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DEVICE","Spinal Cord Stimulator Implantation (SCS)","Spinal cord stimulator implantation is broken up into two parts. The first part involves placement of temporary SCS leads for a one-week trial. If the participants respond favorably to the SCS, then they will undergo the second part and the device is implanted",[18,13],[27],{"name":28,"affiliation":5,"role":29},"Brian Dalm, MD","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Alexander Price","CONTACT","614-366-7822","Alexander.Price2@osumc.edu",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The Ohio State University Wexner Medical Center","RECRUITING","Columbus","Ohio","43210","United States",{"type":45,"coordinates":46},"Point",[47,48],-82.99879,39.96118,{"lat":48,"lon":47},[51,55,56,59,61,63],{"name":52,"role":33,"phone":53,"phoneExt":11,"email":54},"Aladdin Alqaisi","380-283-6363","aladdin.alqaisi@osumc.edu",{"name":28,"role":29,"phone":11,"phoneExt":11,"email":11},{"name":57,"role":58,"phone":11,"phoneExt":11,"email":11},"Kristy Townsend, PhD","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":11,"phoneExt":11,"email":11},"Magdalena Blaszkiewicz, PhD",{"name":62,"role":58,"phone":11,"phoneExt":11,"email":11},"Miriam Freimer, MD",{"name":64,"role":58,"phone":11,"phoneExt":11,"email":11},"Bakri Elsheikh, MD",{"type":29,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Brian Dalm","Associate Professor, Neurological Surgery",[69,72],{"name":70,"class":71},"Neuright, Inc.","UNKNOWN",{"name":73,"class":74},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100538200",false,"NCT06287736","Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy","A Novel Neuromodulation Approach to Target Small Fiber Neuropathy Early in Diabetes and Measure Functional Recovery","Inclusion Criteria:\n\n* Over 18 years old\n* Diagnosis of diabetic peripheral neuropathy refractory to treatment with gabapentin or pregabalin and at least 1 other class of analgesic\n* Diagnosis of medically refractory pain secondary to diabetic neuropathy\n* Presence of pain for 12 months\n* Lower limb pain intensity score ≥4 on a visual analog scale\n* DN4 ≥4\n* Pass pre-operative neuropsychological assessment (surgical group only)\n* Capable of providing informed consent\n\nExclusion Criteria:\n\n* Severe medical comorbidities that, in the opinion of the surgeon, exclude the patient from surgical intervention\n* Spinal disease with severe spinal stenosis or spinal cord compression in the region of the proposed spinal cord stimulator lead placement\n* Coagulopathy that cannot be corrected\n* Unable to discontinue blood thinning medications\n* Hemoglobin A1c level greater than 10\n* Presence of systemic infection\n* Pregnancy","ALL","18 Years",{"count":84,"type":85},60,"ESTIMATED","INTERVENTIONAL",[88],"NA","This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers.",[91],"Diabetic Peripheral Neuropathy","2026-06-15",{"date":94,"type":95},"2026-06-17","ACTUAL",{"date":97,"type":95},"2024-04-17",{"date":99,"type":85},"2029-12-31",{"name":5,"class":6},1]