[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640586":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":50,"centralContacts":56,"locations":66,"responsibleParty":94,"collaborators":97,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":36,"maxAge":36,"enrollmentInfo":110,"targetDuration":36,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":69,"whyStopped":36,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Universidade da Coruña","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Active tVNS paired with conventional Speech Therapy and Physical Therapy","ACTIVE_COMPARATOR","Participants in this arm will receive transcutaneous electrical stimulation applied to the concha of the left ear for 30 minutes, three times a week, over a 4-week period. This location is known to be innervated by the auricular branch of the vagus nerve. In addition, a speech therapy session and a physical therapy session will be added once a week each, while receiving the electrical stimulation.",[13,14,15],"Device: Transcutaneous Electrical Nerve Stimulation (TENS) of Vagus Nerve","Other: Conventional Physical therapy","Other: Conventional Speech Therapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Sham tVNS paired with Speech Therapy and Physical Therapy","SHAM_COMPARATOR","Participants in this arm will receive the same transcutaneous electrical stimulation as the active group, but applied to the earlobe, a site not innervated by the vagus nerve. The procedure, the appearance of the device, and the parameters are identical to those of the active condition to maintain participant blinding. In addition, a speech therapy session and a physical therapy session will be added once a week each, while receiving the electrical stimulation.",[14,15,21],"Device: Sham Transcutaneous Electrical Stimulation of Vagus Nerve",[23,32,37,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Transcutaneous Electrical Nerve Stimulation (TENS) of Vagus Nerve","The tVNS will be performed at 200 microseconds, with frequencies ranging from 20 to 200 Hz (30 seconds\u002F30 seconds) for 30 minutes, in the area innervated by the auricular branch of the vagus nerve (cymba concha and concha). The individually titrated intensity will be set above the sensory threshold (intense tingling sensation) but below the level of discomfort.",[9],[29,30,31],"tVNS","taVNS","transcutaneous auricular vagus nerve stimulation",{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Conventional Physical therapy","Physical therapy delivered to both groups consists of exercises aimed at posture alignment and body coordination, static and dynamic balance improvement, and gait quality. It will be delivered once a week, during a session of electrical stimulation.",[9,17],null,{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Conventional Speech Therapy","It will focus on the orofacial muscles, the acquisition of a diaphragmatic-abdominal breathing pattern that integrates breathing with vocal production, voice training with exercises that enhance vocal quality and prosody, articulation exercises to improve speech clarity, and swallowing training. It will be administered once a week, during one of the three electrical stimulation sessions.",[9,17],{"type":24,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Sham Transcutaneous Electrical Stimulation of Vagus Nerve","The sham- tVNS will be performed at 200 microseconds, with frequencies ranging from 20 to 200 Hz (30 seconds\u002F30 seconds) for 30 minutes, with electrodes placed on the earlobe, which lacks vagus nerve innervation. The individually titrated intensity will be set above the sensory threshold (intense tingling sensation) but below the level of discomfort.",[17],[46,47,48,49],"Sham location","sham-tVNS","sham- taVNS","sham transcutaneous vagus nerve stimulation",[51,54],{"name":52,"affiliation":5,"role":53},"Alicia Martínez-Rodríguez, Lecrurer","PRINCIPAL_INVESTIGATOR",{"name":55,"affiliation":5,"role":53},"Olalla Bello, Lecurer",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":36,"email":61},"Alicia Martínez-Rodríguez alicia.martinez@udc.es, Lecturer","CONTACT","+34 881015851","alicia.martinez@udc.es",{"name":63,"role":59,"phone":64,"phoneExt":36,"email":65},"Olalla Bello, Lecturer","+34 881015852","olalla.bello@udc.es",[67],{"facility":68,"status":69,"city":70,"state":36,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Association of Parkinson´s Disease Galicia- Coruña","RECRUITING","A Coruña","15008","Spain","ES",{"type":75,"coordinates":76},"Point",[77,78],-8.396,43.37135,{"lat":78,"lon":77},[81,85,88,90,92],{"name":82,"role":59,"phone":83,"phoneExt":36,"email":84},"Alba Gómez-Rodríguez","+34 618950128","logopedia3@parkinsongaliciacoruna.org",{"name":86,"role":87,"phone":36,"phoneExt":36,"email":36},"Alba Gómez-Rodríguez, Ph.D. student","SUB_INVESTIGATOR",{"name":89,"role":87,"phone":36,"phoneExt":36,"email":36},"María Belén López-Ferreiro",{"name":91,"role":87,"phone":36,"phoneExt":36,"email":36},"Sandra García González",{"name":93,"role":87,"phone":36,"phoneExt":36,"email":36},"María Rodríguez Losada",{"type":53,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Alicia Martínez Rodríguez","Lecturer; Faculty of Physical Therapy. Researcher; Psychosocial Intervention and Functional Rehabilitation Group",[98],{"name":99,"class":100},"Parkinson´s Association Galicia-Coruña","UNKNOWN","100640586","effects-of-transcutaneous-vagus-nerve-stimulation-in-parkinsons-disease-100640586",false,"NCT07588191","Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease","Effects of Transcutaneous Stimulation of the Auricular Branch of the Vagus Nerve in Parkinson´s Disease","tVNS_PD","Inclusion Criteria:\n\n* Being a member of the Association or be interested in joining;\n* Idiopathic PD diagnosis, stages 2-3 according to the Hoehn \\& Yahr scale; confirmed by neurologist\n* Ability to walk independently for at least 1 minute ant turn 180° without assistance;\n* Exhibiting symptoms of hypokinetic dysarthria;\n* On stable dopaminergic therapy for at least 1 month prior to the experiment\n\nExclusion Criteria:\n\n* Any contraindication for taVNS (e.g., ear lesions, pacemakers, defibrillators, or other electronic devices)\n* Previous vagotomy or previous application of electrical stimulation to the ear or brain, or treatment with high-intensity focused ultrasound (HIFU)\n* Voice or speech disorders caused by other medical conditions\n* MoCA score below 21\n* Psychotic symptoms or hallucinations; a diagnosis of psychiatric illness\n* Systolic blood pressure above 160 mm Hg, and diastolic blood pressure above 100 mm Hg\n* Inability to attend sessions;\n* Concomitant neurological, orthopaedic, cardiac, respiratory or active medical\u002Foncological condition that would affect participation","ALL",{"count":111,"type":112},46,"ESTIMATED","INTERVENTIONAL",[115],"NA","This study aims to determine whether electrical stimulation of the ear, when combined with physical and speech therapy, can improve symptoms in subjects diagnosed with Parkinson´s disease, by comparing two different application sites.\n\nEach subject will undergo an initial in-person screening and provide consent before participating in the study.\n\nThe main questions to answer are:\n\n* Does transcutaneous electrical nerve stimulation (tVNS) in the ear paired with physical and speech therapy improve speech and voice-related problems, airway protection, salivation, and swallowing?\n* Does tVNS paired with physical and speech therapy improve tremor, walking speed, and balance in people with PD?\n* Does tVNS paired with physical and speech therapy improve heart rate and heart rate variability in people with PD?\n* Do its effects persist at 8 weeks?\n\nParticipants will:\n\nAttend 12 rehabilitation sessions over 4 weeks (three per week). During each session, participants received either active or sham tVNS, accompanied by speech therapy (once per week), physical therapy (once per week), or conducted alone (once per week).\n\nUndergo speech, voice, swallowing, respiratory, gait, balance, tremor, heart rate variability, and cognitive testing, as well as questionnaires regarding the quality of life, before and after treatment.\n\nReturn for a follow-up visit eight weeks after therapy to check how long the effects last.",[118,119],"Transcutaneous Vagal Nerve Stimulation (tVNS)","Parkinson Disease (PD)",[121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137],"transcutaneous electrical nerve stimulation","Vagus Nerve","Parkinson Disease","Speech Therapy","Physical Therapy Modalities","Deglutition","Tremor","Posture","Gait","Quality of Life","cognition","cough","Sialorrhea","Xerostomia","Heart Rate","voice disorders","Ear","2026-05-15",{"date":140,"type":141},"2026-05-19","ACTUAL",{"date":143,"type":112},"2026-05",{"date":145,"type":112},"2026-11",{"name":5,"class":6},1]