[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"motor-fluctuations\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:motor-fluctuations":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,62],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100621337","comparing-biomarker-guided-dbs-programming-with-standard-clinical-monopolar-programming-100621337",false,"NCT07369310","Comparing Biomarker-Guided DBS Programming With Standard Clinical Monopolar Programming","Randomized Trial on DBS Programming Based on Biomarkers vs. Standard Monopolar Review","Inclusion Criteria:\n\n* Age between 30 and 70 years.\n* Confirmed diagnosis of idiopathic Parkinson's disease according to the MDS diagnostic criteria (Postuma et al., 2015).\n* Indication for deep brain stimulation surgery based on CAPSIT-PD criteria.\n\nExclusion Criteria:\n\n* Presence of severe surgical complications (e.g., intracranial hemorrhage, infection).\n* Postoperative adverse events requiring electrode repositioning.\n* Any other medical or neurological condition that could interfere with safe participation in the trial.","ALL","30 Years","70 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn whether an objective, data-guided approach to programming deep brain stimulation (DBS) can improve motor outcomes in people with Parkinson's disease who undergo DBS surgery. The study includes adults aged 30 to 70 years with Parkinson's disease who are candidates for DBS.\n\nThe main questions it aims to answer are:\n\nDoes DBS programming based on objective markers (brain imaging and brain signals) reduce the amount of daily time patients spend in the OFF state more than conventional clinical programming?\n\nDoes this programming approach improve quality of life and motor symptoms compared with standard programming?\n\nResearchers will compare conventional DBS programming based on clinical monopolar review with DBS programming guided by electrode location on neuroimaging and beta brain signals recorded from the implanted device, to see if the objective approach leads to better motor control and less OFF time.\n\nParticipants will:\n\nUndergo DBS surgery using a clinically approved DBS system\n\nBe randomly assigned to one of two DBS programming strategies\n\nWear inertial sensors at home for several days at different time points to objectively measure motor symptoms\n\nAttend scheduled clinical visits for DBS programming and motor and non-motor assessments\n\nHave adaptive DBS activated after 3 months and continue follow-up until 6 months after programming begins",[27,28,29,30,31,32],"Parkinson's Disease","Parkinson","Parkinsons Disease (PD)","Motor Fluctuations","DBS","Deep Brain Stimulation",[27,32,34,35,36,37,38,39,40,41,42,43,44,30,45,46,47,48],"DBS Programming","Monopolar Review","Local Field Potentials","Beta Oscillations","BrainSense","Medtronic Percept","Neuroimaging-Guided Programming","Objective Programming","Adaptive Deep Brain Stimulatoin","Wearable Sensors","Inertial Sensors","OFF Time","Dyskinesia","Neuromodulation","Subthalamic Nucleus","NOT_YET_RECRUITING","2026-01-26",{"date":52,"type":53},"2026-01-27","ACTUAL",{"date":55,"type":21},"2026-03-01",{"date":57,"type":21},"2028-09-01",{"name":59,"class":60},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","OTHER",1,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100560827","enabling-women-with-parkinsons-disease-to-identify-and-better-manage-hormonal-triggers-of-parkinsonian-symptoms-100560827","NCT06582212","Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms","Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers","Lady-PD","Inclusion Criteria:\n\n* Non-menopausal women\n* Diagnosis of PD according to the MDS criteria onset of PD symptoms since at least two years before inclusion\n* Age 18-56 years\n* On stable medication regimen for PD for at least two months without foreseen need to modify it within the next three months\n* With and without OCP or intrauterine devices (IUD\n\nExclusion Criteria:\n\n* Post-menopausal women with PD\n* Any condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures (i.e., dementia, severe depression, etc.)\n* People not able to give an informed consent.","FEMALE","18 Years","56 Years",{"count":74,"type":21},100,[24],"Forty percent of people living worldwide with Parkinson's disease (PD) are women. Twenty percent of patients have PD onset under the age of 60 years, a time when women may encounter significant caregiving responsibilities along with occupational and other competing demands.\n\nStudies with surveys of women with PD (WwPD) have reported worsening of PDrelated symptoms especially in the week prior and the week of menses. However, prospective evidence is scarce and clinical guidelines to manage this issue do not exist. As a result, care is either non-existent or fragmented.\n\nThe investigators propose a French multicentre prospective pilot study to capture changes in PD symptoms in relation to the stages of the menstrual cycle aiming at reducing hormonal related worsening in PD symptoms through neurologist intervention and\u002For patient selfmanagement.\n\nDigital technology will remotely enable patient reported outcome (PRO) tracking through the My Moves Matter app changes in PD symptoms during several months. This information will then help neurologists to customize treatment.\n\nChanges in motor symptoms will also be highlighted by tracking through the use of a wearable device (PDMonitor) to objectively detect motor changes together with the app.\n\nThis will further support the reliability of the app. This study will provide evidence for the impact of the menstrual cycle on PD and help neurologists and patients to better manage PD symptoms related to these hormonal changes.",[78,79,30,80,81],"Digital Technology","Mobile Application","Oestrogen","Parkinson Disease","RECRUITING","2025-03-24",{"date":85,"type":53},"2025-03-25",{"date":87,"type":53},"2025-03-12",{"date":89,"type":21},"2027-09-12",{"name":91,"class":60},"University Hospital, Grenoble",4]