[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540215":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":41,"studyPopulation":42,"armGroups":43,"interventions":49,"overallOfficials":55,"centralContacts":60,"locations":65,"responsibleParty":155,"collaborators":157,"id":161,"slug":38,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":162,"sex":168,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":38,"studyType":174,"phases":38,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":68,"whyStopped":38,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Heinrich-Heine University, Duesseldorf","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of (Serious) Adverse Events","Number of adverse events (without causal relationship to therapy) AE, SAE (query after the first 6-cycle block and before each booster) scaling according to NRS (1-10) for each ADE (query before each stimulation)","through study completion, an average of 1 year",{"measure":14,"description":15,"timeFrame":12},"Number of adverse device effects","Number of ADEs and (U)SADEs scaling according to NRS (1-10) for each ADE (query before each stimulation)",[17,21,24,27,30],{"measure":18,"description":19,"timeFrame":20},"ADAS","Alzheimer's Disease Asessment Scale (ADAS) baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)","Baseline, post first 6 sessions and after 3, 6, 9 and 12 months",{"measure":22,"description":23,"timeFrame":20},"Mini Mental State Examination (MMSE) baseline and follow- up","Mini Mental State Examination (MMSE) baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)",{"measure":25,"description":26,"timeFrame":20},"BDI-II","BDI-II baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)",{"measure":28,"description":29,"timeFrame":20},"Clinical Dementia Rating Sum of Boxes Score (CDR-SB)","Clinical Dementia Rating Sum of Boxes Score (CDR-SB) baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)",{"measure":31,"description":32,"timeFrame":20},"Alzheimer's Disease Cooperative Study\u002F Activities of Daily Living Scale (ADCS-ADL)","Alzheimer's Disease Cooperative Study\u002F Activities of Daily Living Scale (ADCS-ADL) at baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)",[34],{"measure":35,"description":35,"timeFrame":36},"Numeric Rating Scale (NRS) for the main symptom","12 months",{"allocation":38,"interventionModel":38,"interventionModelDescription":38,"primaryPurpose":38,"observationalModel":39,"timePerspective":40,"maskingInfo":38},null,"CASE_ONLY","PROSPECTIVE","This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores. Adverse effects and adverse events without a clear causal relationship will be documented in terms of frequency and severity. Furthermore, the progression of improvement in Alzheimer's symptoms as a result of TPS treatment is summarized in various neuropsychological scales.","AD Patients undergoing TPS",[44],{"label":45,"type":38,"description":46,"interventionNames":47},"Patients with Clinical Alzheimer's syndrome treated with TPS","Patients with clinical Alzheimer's syndrome, defined by a gradually progressive change in memory function (for severity using the MMSE as a screening tool) and impairment of activities of daily living for more than six months that have planned treatment with TPS",[48],"Diagnostic Test: Registry",[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":38},"DIAGNOSTIC_TEST","Registry","Clinical data collection of patients scheduled for on-label treatment",[45],[56],{"name":57,"affiliation":58,"role":59},"Lars Wojtecki, Prof. Dr.","Heinrich-Heine-Universität","PRINCIPAL_INVESTIGATOR",[61],{"name":57,"role":62,"phone":63,"phoneExt":38,"email":64},"CONTACT","+492118106756","wojtecki@uni-duesseldorf.de",[66,85,101,116,130,140],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie","RECRUITING","Potsdam","Brandenburg","14467","Germany","DE",{"type":75,"coordinates":76},"Point",[77,78],13.06566,52.39886,{"lat":78,"lon":77},[81],{"name":82,"role":62,"phone":83,"phoneExt":38,"email":84},"Martin Südmeyer, Prof. Dr. med.","+4933124137102","martin.suedmeyer@klinikumevb.de",{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":72,"countryCode":73,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Evangelische Krankenhausstiftung Oldenburg - Universitätsklinik für Neurologie","NOT_YET_RECRUITING","Oldenburg","Lower Saxony","26122",{"type":75,"coordinates":92},[93,94],8.21479,53.14039,{"lat":94,"lon":93},[97],{"name":98,"role":62,"phone":99,"phoneExt":38,"email":100},"Karsten Witt, Prof. Dr. med.","+49 441 236 649","karsten.witt@evangelischeskrankenhaus.de",{"facility":102,"status":87,"city":103,"state":104,"zip":105,"country":72,"countryCode":73,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen","Bonn","North Rhine-Westphalia","53127",{"type":75,"coordinates":107},[108,109],7.09549,50.73438,{"lat":109,"lon":108},[112],{"name":113,"role":62,"phone":114,"phoneExt":38,"email":115},"Ullrich Wüllner, Prof. Dr. med.","+49 22828713166","Ullrich.Wuellner@ukbonn.de",{"facility":117,"status":87,"city":118,"state":104,"zip":119,"country":72,"countryCode":73,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Neurologische Praxis Prof. Wojtecki","Neuss","41460",{"type":75,"coordinates":121},[122,123],6.68504,51.19807,{"lat":123,"lon":122},[126],{"name":127,"role":62,"phone":128,"phoneExt":38,"email":129},"Lars Wojtecki, Prof. Dr. med.","+49 1520 54 53 361","info@brain-clinic.de",{"facility":131,"status":132,"city":133,"state":38,"zip":134,"country":72,"countryCode":73,"cosmosGeoPoint":135,"geoPoint":139,"contacts":38},"Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation","WITHDRAWN","Kempen","47906",{"type":75,"coordinates":136},[137,138],6.41858,51.36432,{"lat":138,"lon":137},{"facility":141,"status":68,"city":142,"state":38,"zip":143,"country":72,"countryCode":73,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Praxis Dr. Schwarz","Ulm","89073",{"type":75,"coordinates":145},[146,147],9.99155,48.39841,{"lat":147,"lon":146},[150],{"name":151,"role":62,"phone":152,"phoneExt":153,"email":154},"Alexander Schwarz, Dr. med.","+49731922","6620","kontakt@tps-zentrum.de",{"type":156,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[158],{"name":159,"class":160},"Storz Medical AG","INDUSTRY","100540215",false,"NCT06313944","German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation","German (GE) Multicenter Prospective Data Collection (Registry) on Treatment With Transcranial Pulse Wave Stimulation (TPS) in Patients With Alzheimer's Disease (A)","GE-R-A-TPS","Inclusion Criteria:\n\ni. Age = 18 to 85 ii. N\\>=100, clinical Alzheimer's syndrome, defined by a gradually progressive change in memory function (for severity using the MMSE as a screening tool) and impairment of activities of daily living for more than six months iii. MRI scan, in vivo evidence from CSF and\u002For PET using the NIA-AA criteria, which categorize the underlying pathological processes based on biomarkers, should be added if possible, but are optional. These biomarkers are categorized as ß-amyloid deposition, pathological tau and neurodegeneration \\[AT(N)\\], which can be detected on imaging and in biofluids. If possible, patients with Alzheimer's disease (AD) or Alzheimer's continuum should be included.\n\niv. TPS treatment in a center of a neurological or psychiatric specialist and performed under supervision of a specialist\n\nExclusion Criteria:\n\ni. Relevant intracerebral pathologies not related to Alzheimer's disease, such as vascular encephalopathy Fazekas grade 3, tumors, vascular malformations, pregnancy, metal implants, CAA according to Boston criteria, Z.n. or during antibody therapy ii. Blood coagulation disorders or oral anticoagulation iii. Epilepsy iv. Medical conditions leading to non-compliance with the protocol","ALL","18 Years","85 Years",{"count":172,"type":173},100,"ESTIMATED","OBSERVATIONAL","This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores.",[177],"Alzheimer Disease",[177,179],"Transcranial Pulse Wave Stimulation (TPS)","2026-06-08",{"date":182,"type":183},"2026-06-10","ACTUAL",{"date":185,"type":183},"2025-08-06",{"date":187,"type":173},"2026-10-01",{"name":5,"class":6},6]