[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652950":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":57,"collaborators":31,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":31,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":31,"maxAge":31,"enrollmentInfo":68,"targetDuration":31,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":84,"whyStopped":31,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Umeå University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"equence 1: Active BurstDR → Sham","EXPERIMENTAL","Following a 1-day baseline observation under established active BurstDR settings, participants undergo a 4-day washout period with stimulation switched off. They then receive 7 days of active BurstDR spinal cord stimulation using their established clinically effective settings. After a second 4-day washout period with stimulation switched off, participants receive 7 days of sham stimulation, during which stimulation output remains switched off.",[13,14],"Device: BurstDR Spinal Cord Stimulation","Device: Sham Spinal Cord Stimulation",{"label":16,"type":10,"description":17,"interventionNames":18},"Sequence 2: Sham → Active BurstDR","Following a 1-day baseline observation under established active BurstDR settings, participants undergo a 4-day washout period with stimulation switched off. They then receive 7 days of sham stimulation, during which stimulation output remains switched off. After a second 4-day washout period with stimulation switched off, participants receive 7 days of active BurstDR spinal cord stimulation using their established clinically effective settings.",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","BurstDR Spinal Cord Stimulation","Active BurstDR spinal cord stimulation is delivered for 7 consecutive days using each participant's established clinically effective stimulation settings. Electrode configuration, pulse pattern, pulse width, frequency structure, and amplitude are maintained according to the participant's established therapeutic program, with any adjustment required to maintain imperceptible stimulation completed before the randomized treatment periods.",[16,9],[26],"Passive Recharge Burst Spinal Cord Stimulation",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Sham Spinal Cord Stimulation","During sham stimulation, the implanted spinal cord stimulation system remains in place but stimulation output is switched off for 7 consecutive days. The participant-facing programmer is locked and visible device information that could reveal treatment allocation is masked. Study contacts, diary assessments, and follow-up procedures are otherwise equivalent to those during active stimulation.",[16,9],null,[33],{"name":34,"affiliation":5,"role":35},"Pedram Tabatabaei, MD, PhD","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":31,"email":40},"CONTACT","+46-70-7603239","pedram.tabatabaei@umu.se",[42],{"facility":43,"status":31,"city":44,"state":31,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University Hospital of Northern Sweden","Umeå","90185","Sweden","SE",{"type":49,"coordinates":50},"Point",[51,52],20.25972,63.82842,{"lat":52,"lon":51},[55],{"name":34,"role":38,"phone":56,"phoneExt":31,"email":40},"+46707603239",{"type":35,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Pedram Tabatabaei Shafiei","MD, PhD","100652950","burstdr-spinal-cord-stimulation-versus-sham-in-established-responders-100652950",false,"NCT07779733","BurstDR Spinal Cord Stimulation Versus Sham in Established Responders","Passive Recharge Burst Spinal Cord Stimulation vs Sham Stimulation in Established Responders: A Randomized, Double-Blind Crossover Clinical Trial","Inclusion Criteria\n\nParticipants must meet all of the following:\n\n1. Be 18 years of age or older.\n2. Have an implanted spinal cord stimulation system that can deliver BurstDR stimulation.\n3. Have had a good and stable response to BurstDR therapy, defined as at least a 50% reduction in pain compared with pain before implantation or before starting BurstDR therapy, maintained for at least 3 months on stable stimulation settings.\n4. Have had no major change in pain medication for at least 4 weeks before entering the study.\n5. Be able to understand the study information and provide written informed consent.\n6. Be willing and able to complete the study's electronic diaries and follow the study procedures.\n\nExclusion Criteria\n\nParticipants cannot take part if any of the following apply:\n\n1. An active infection, wound problem, or other significant problem at the site of the implanted spinal cord stimulation system.\n2. A known or suspected problem with the implanted stimulation system that could affect treatment delivery or safety.\n3. A serious uncontrolled mental health condition, significant problems with memory or thinking, or another condition that could make it difficult to understand the study, provide informed consent, follow the study procedures, or provide reliable study information.\n4. Planned surgery, planned changes to spinal cord stimulation programming outside the study, or an expected change in pain medication during the study period.\n5. Pregnancy or breastfeeding.\n6. Inability to use the electronic diary system when no practical alternative or assistance can be provided.\n7. Any other medical or personal condition that, in the investigator's judgment, would make participation unsafe or inappropriate.","ALL",{"count":69,"type":70},28,"ESTIMATED","INTERVENTIONAL",[73],"NA","This study aims to determine whether ongoing BurstDR spinal cord stimulation (SCS) provides pain relief beyond sham stimulation in patients with chronic pain who are established responders to BurstDR therapy.\n\nParticipants already implanted with an SCS system and experiencing stable clinical benefit from BurstDR will undergo both active stimulation and sham stimulation in a randomized, double-blind crossover design. Each participant will therefore serve as their own control.\n\nThe primary question is whether pain intensity is lower during active BurstDR stimulation compared with sham stimulation. The study will also evaluate treatment satisfaction, patient-reported changes in sleep, mood, daily activity and social activity, the effectiveness of blinding, and short-term safety and tolerability.",[76],"Chronic Pain",[78,26,79,80,81,82,83],"Spinal Cord Stimulation","Burst Stimulation","Neuromodulation","Sham Stimulation","Paresthesia-Free Stimulation","Established Responders","NOT_YET_RECRUITING","2026-08-18",{"date":87,"type":88},"2026-08-21","ACTUAL",{"date":90,"type":70},"2026-09-30",{"date":92,"type":70},"2027-03-31",{"name":5,"class":6},1]