[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429358":3},{"organization":4,"outcomesModule":7,"designInfo":91,"detailedDescription":90,"studyPopulation":94,"armGroups":95,"interventions":104,"overallOfficials":112,"centralContacts":116,"locations":121,"responsibleParty":143,"collaborators":146,"id":150,"slug":90,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":151,"sex":156,"minAge":157,"maxAge":90,"enrollmentInfo":158,"targetDuration":90,"studyType":161,"phases":90,"briefSummary":162,"conditions":163,"keywords":90,"overallStatus":124,"whyStopped":90,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"University of Ulm","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":90},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score","Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted","2 weeks",{"measure":14,"description":15,"timeFrame":12},"Inflammatory Neuropathy Cause and Treatment (INCAT) disability score","Standard clinical score for inflammatory neuropathies.",{"measure":17,"description":18,"timeFrame":12},"Oxford Muscle Strength Score (Medical Research Council, MRC)","Standard clinical score for evaluating muscle strength \u002F paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity).",{"measure":20,"description":21,"timeFrame":12},"Vibration Score","Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides).",[23,25,26,27,28,32,35,39,42,45,48,51,54,57,60,63,66,69,72,75,78,81,84,87],{"measure":10,"description":11,"timeFrame":24},"1, 3, and 5 weeks",{"measure":14,"description":15,"timeFrame":24},{"measure":17,"description":18,"timeFrame":24},{"measure":20,"description":21,"timeFrame":24},{"measure":29,"description":30,"timeFrame":31},"Hughes Score","Standard clinical score to quantify disability in Guillain-Barré syndrome","1, 2, 3, and 5 weeks",{"measure":33,"description":34,"timeFrame":31},"Pain","Pain quantified on a visual analog scale between 0 (no pain) and 10 (maximum pain).",{"measure":36,"description":37,"timeFrame":38},"N20","N20 latency of nervus medianus (both sides) as measured by somatosensory evoked potentials (SEPs)","2 and 5 weeks",{"measure":40,"description":41,"timeFrame":38},"P40","P40 latency of nervus tibialis (both sides) as measured by somatosensory evoked potentials",{"measure":43,"description":44,"timeFrame":38},"Nerve Conduction Velocity","Nerve conduction velocity of clinically affected nerves as measured by electroneurography (ENG)",{"measure":46,"description":47,"timeFrame":31},"Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)","Quality of Life Scale",{"measure":49,"description":50,"timeFrame":31},"Immunoglobulin A in serum","Immunoglobulin A serum concentration",{"measure":52,"description":53,"timeFrame":12},"Immunoglobulin A in cerebrospinal fluid (CSF)","Immunoglobulin A concentration in cerebrospinal fluid",{"measure":55,"description":56,"timeFrame":31},"Immunoglobulin G in serum","Immunoglobulin G serum concentration",{"measure":58,"description":59,"timeFrame":12},"Immunoglobulin G in cerebrospinal fluid (CSF)","Immunoglobulin G concentration in cerebrospinal fluid",{"measure":61,"description":62,"timeFrame":31},"Immunoglobulin M in serum","Immunoglobulin M serum concentration",{"measure":64,"description":65,"timeFrame":12},"Immunoglobulin M in cerebrospinal fluid (CSF)","Immunoglobulin M concentration in cerebrospinal fluid",{"measure":67,"description":68,"timeFrame":31},"Interleukin-1","Interleukin-1 serum concentration",{"measure":70,"description":71,"timeFrame":31},"Interleukin-6","Interleukin-6 serum concentration",{"measure":73,"description":74,"timeFrame":31},"Anti-GM1 antibodies","Anti-GM1 antibody serum levels",{"measure":76,"description":77,"timeFrame":31},"Anti-GQ1b","Anti-GQQ1b antibody serum levels",{"measure":79,"description":80,"timeFrame":31},"Neurofilament light chain (NfL) serum","Neurofilament light chain (NfL) serum levels",{"measure":82,"description":83,"timeFrame":12},"Neurofilament light chain (NfL) in cerebrospinal fluid (CSF)","Neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF)",{"measure":85,"description":86,"timeFrame":31},"Safety and Tolerability","Kind and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)",{"measure":88,"description":89,"timeFrame":31},"Therapeutic Response","Share of patients with at least 20% improvement in CIDP score",null,{"allocation":90,"interventionModel":90,"interventionModelDescription":90,"primaryPurpose":90,"observationalModel":92,"timePerspective":93,"maskingInfo":90},"COHORT","PROSPECTIVE","The study population consists of patients diagnosed with Guillain-Barré syndrome (GBS) who are treated with either plasma exchange or immunoadsorption in the Department of Neurology, University of Ulm.",[96,100],{"label":97,"type":90,"description":90,"interventionNames":98},"Immunoadsorption",[99],"Device: Immunoadsorption",{"label":101,"type":90,"description":90,"interventionNames":102},"Plasma Exchange",[103],"Device: Plasma Exchange",[105,109],{"type":106,"name":97,"description":107,"armGroupLabels":108,"otherNames":90},"DEVICE","1 cycle, consisting of 5 sessions on 5 consecutive days with processing of the 0.7-fold individual plasma volume (maximum 2.5 l) each days with tryptophan adsorbers.",[97],{"type":106,"name":101,"description":110,"armGroupLabels":111,"otherNames":90},"1 cycle, consisting of 5 sessions on 5 consecutive days with exchange of 0.7-fold plasma volume (maximum 2.5 l) each day with albumin solution as volume replacement solution.",[101],[113],{"name":114,"affiliation":5,"role":115},"Johannes Dorst, Prof","PRINCIPAL_INVESTIGATOR",[117],{"name":114,"role":118,"phone":119,"phoneExt":90,"email":120},"CONTACT","+49 731 177 5285","johannes.dorst@uni-ulm.de",[122],{"facility":123,"status":124,"city":125,"state":126,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":135,"contacts":136},"Department of Neurology, University of Ulm","RECRUITING","Ulm","Baden-Wurttemberg","89081","Germany","DE",{"type":131,"coordinates":132},"Point",[133,134],9.99155,48.39841,{"lat":134,"lon":133},[137,142],{"name":138,"role":118,"phone":139,"phoneExt":140,"email":141},"Albert C Ludolph, MD, Prof.","+49-731-177-","1200","albert.ludolph@rku.de",{"name":138,"role":115,"phone":90,"phoneExt":90,"email":90},{"type":115,"investigatorFullName":144,"investigatorTitle":145,"investigatorAffiliation":5,"oldNameTitle":90,"oldOrganization":90},"Albert Christian Ludolph, Prof.","Prof. Dr.",[147],{"name":148,"class":149},"DiaMed GmbH","INDUSTRY","100429358",false,"NCT04871035","Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)","IPET-GBS","Inclusion Criteria:\n\n* Diagnosis of Guillain-Barré Syndrome according to the diagnostic criteria proposed by Doorn et al. (Clinical features, pathogenesis, and treatment of Guillain-Barré syndrome, Lancet neurology 2008)\n* age 18 years or above\n\nExclusion Criteria:\n\n* Clinical or laboratory (C-reactive protein 20 mg\u002Fl or above, or evidence of nitrite-positive urinary tract infection) evidence of manifest systemic infection\n* Intake of angiotensin converting enzyme inhibitor within1 weeks before first treatment\n* Other contraindications against immunoadsorption or plasma exchange","ALL","18 Years",{"count":159,"type":160},20,"ESTIMATED","OBSERVATIONAL","This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.",[164],"GBS","2026-04-30",{"date":167,"type":168},"2026-05-01","ACTUAL",{"date":170,"type":168},"2021-04-28",{"date":172,"type":160},"2027-09-01",{"name":5,"class":6},1]