[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618869":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":66,"centralContacts":71,"locations":75,"responsibleParty":81,"collaborators":75,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":75,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":111,"whyStopped":75,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":75},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Campus Bio-Medico","OTHER",[8,16,20,26],{"label":9,"type":10,"description":11,"interventionNames":12},"taVNS paired with sensorized treadmill training (STT) and conventional physical therapy (cPT)","ACTIVE_COMPARATOR","Participants will receive active taVNS, stimulation parameters: 25 Hz frequency, 200 μs pulse width, and intensity adjusted to the individual's sensory threshold, delivered to the left auricular tragus for the duration of each session (\\~30 minutes). During stimulation, participants will perform treadmill walking on a sensorized treadmill system with simultaneous conventional physical therapy exercises focused on posture, balance, and gait re-education. Sessions will occur three times per week for four weeks (12 sessions total).",[13,14,15],"Procedure: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)","Other: Conventional Physical Therapy (cPT)","Other: Sensorized Treadmill Training (STT)",{"label":17,"type":10,"description":18,"interventionNames":19},"taVNS paired with conventional physical therapy (cPT)","Participants will receive active taVNS (same parameters and device as Arm 1) during conventional physical therapy sessions without treadmill training.\n\nSessions will occur three times per week for four weeks.",[13,14],{"label":21,"type":22,"description":23,"interventionNames":24},"Sham taVNS paired with STT and cPT","SHAM_COMPARATOR","Sham stimulation will consist of few impulses delivered at 25 Hz for a duration of 60'' before waning, creating the same initial sensation without continuous current delivering.\n\nParticipants will simultaneously undergo treadmill-based and conventional physical therapy as described above.\n\nSchedule: three sessions per week for four weeks.",[25,14,15],"Procedure: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS)",{"label":27,"type":22,"description":28,"interventionNames":29},"Sham taVNS paired with cPT","Participants will receive sham stimulation (same device and sham procedure as Arm 3) during conventional physical therapy sessions without treadmill training.\n\nSchedule: three sessions per week for four weeks.",[25,14],[31,42,50,57],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)","Active taVNS delivered at the inner tragus of the left ear (25 Hz, 200 μs, intensity at sensory threshold)",[17,9],[37,38,39,40,41],"Transcutaneous Auricular Vagus Nerve Stimulation","taVNS","nVNS","tVNS","Transauricular Vagus Nerve Stimulation",{"type":32,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS)","Sham taVNS using the electrode placement as active taVNS but without electrical stimulation beyond the initial sensation.",[21,27],[47,48,49],"Sham transcutaneous auricular vagus nerve stimulation","sham taVNS","sham",{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Conventional Physical Therapy (cPT)","Conventional Physical Therapy delivered to all groups consist of exercises aimed at posture alignment, reduction of hypertone, balance improvement and overground gait training.",[21,27,17,9],[55,56],"Conventional Physical Therapy","cPT",{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Sensorized Treadmill Training (STT)","Sensorized Treadmill Training consist of a sensorized gait treadmill training with continuous visual feedback combined with dual cognitive tasks (e.g. repeat digits, repeat sequence of words, counting down the dates).",[21,9],[62,63,64,65],"Sensorized Treadmill Training","STT","treadmill","sensorized treadmill",[67],{"name":68,"affiliation":69,"role":70},"Massimo Marano, MD, PhD","Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy","PRINCIPAL_INVESTIGATOR",[72,77],{"name":68,"role":73,"phone":74,"phoneExt":75,"email":76},"CONTACT","+39 3333488802",null,"m.marano@policlinicocampus.it",{"name":78,"role":73,"phone":79,"phoneExt":75,"email":80},"Gaia Anzini, MD","+39 3662007406","gaia.anzini@unicampus.it",{"type":70,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":75,"oldOrganization":75},"Massimo Marano","Principal Investigator","100618869","association-of-vagus-nerve-stimulation-and-treadmill-training-for-gait-rehabilitation-in-de-novo-parkinsons-disease-100618869",false,"NCT07337226","Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease","Association of VAgus Nerve Stimulation and Treadmill Training for GAit Rehabilitation in DE Novo Parkinson's Disease (AVANTGARDE-PD)","AVANTGARDE-PD","Inclusion Criteria:\n\n* Idiopathic PD diagnosis within 6 months, confirmed by neurologist specialized in Parkinson's disease and movement disorders;\n* Ability to walking independently for at least 10 meters unassisted;\n* Age included between 50 and 80;\n* MMSE \\> 24;\n* On stable therapy for at least 1 month prior to the experiment.\n\nExclusion Criteria:\n\n* Clinical and radiological red flags for atypical, vascular parkinsonism or alternative diagnosis (e.g., normal pressure hydrocephalus);\n* Levodopa equivalent daily dose \\> 300 mg;\n* Any contraindication for taVNS (e.g., ear lesions, auditory prosthesis)\n* Any contraindication for MRI (e.g., non compatible pacemakers or prosthesis, claustrophobic subjects);\n* Concomitant neurological, orthopedic or active medical\u002Foncological condition that would affect participating to the study;\n* Attempting to other neurorehabilitation programs within 3 months.","ALL","50 Years","80 Years",{"count":96,"type":97},60,"ESTIMATED","INTERVENTIONAL",[100],"NA","The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) can improve gait and brain function in people with diagnosis of idiopathic Parkinson's disease (PD) within 6 months. It will also help researchers learn about the safety and biological effects of taVNS when used together with physical therapy.\n\nThe main questions it aims to answer are:\n\n* Does taVNS paired with physical therapy improve walking speed and gait performance in people with PD?\n* Does taVNS change brain activity or breain perfusion related to movement?\n* Does taVNS reduce markers of inflammation and neurodegeneration in blood and saliva? Researchers will compare active taVNS to sham (placebo) stimulation to see if active taVNS works better when paired with physical therapy.\n\nParticipants will:\n\n* Attend 12 rehabilitation sessions over 4 weeks (three per week)\n* Receive either active or sham taVNS during each session while doing treadmill and conventional physical therapy\n* Undergo gait and cognitive testing, MRI scans, and blood and saliva collection before and after treatment\n* Return for a follow-up visit four weeks after therapy to check how long the effects last",[103],"Idiopathic Parkinson's Disease (PD)",[105,106,107,108,109,110],"Parkinson's disease","Vagus nerve stimulation","non invasive brain stimulation","treadmill training","freezing of gait","rehabilitation","NOT_YET_RECRUITING","2026-01-04",{"date":114,"type":115},"2026-01-13","ACTUAL",{"date":117,"type":97},"2026-01",{"date":119,"type":97},"2027-10",{"name":5,"class":6}]