[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559318":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":67,"collaborators":22,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":22,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":22,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":48,"whyStopped":22,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","Vagal nerve stimulation at an intensity under 10 units. Participants will self-administered at this intensity for 2 minutes each day over 4 weeks.",[13],"Device: non-invasive cervical vagal nerve stimulation ncVNS",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2","Vagal nerve stimulation at the highest intensity tolerated by the participant. Participants will self-administered at this intensity for 12 minutes each day over 4 weeks.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Group 3","NO_INTERVENTION","This group will not receive any stimulation. Participants will receive their treatment as usual.",null,[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","non-invasive cervical vagal nerve stimulation ncVNS","The ncVNS device is a rechargable, handheld device that generate a proprietary frequency-modulated electrical stimulus at low voltage (max 24V) with a max current output of 60mA. The signal consists of 1ms bursts of 5kHz sine waves repeated at 25Hz. Two stainless steel contact surfaces coated with conductive gel deliver the stimulus to the neck in the vicinity of the vagus nerve.",[9,15],[30],"VNS",[32],{"name":33,"affiliation":34,"role":35},"Sandra L. Kletzel, PhD BA","Edward Hines Jr. VA Hospital, Hines, IL","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":22,"email":41},"Sandra L Kletzel, PhD BA","CONTACT","(708) 202-5735","Sandra.Kletzel@va.gov",{"name":43,"role":39,"phone":44,"phoneExt":22,"email":45},"Alexandria N Umbarger, BS","(708) 998-8213","alexandria.umbarger@va.gov",[47],{"facility":34,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Hines","Illinois","60141-3030","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-87.8395,41.85364,{"lat":58,"lon":57},[61,65,66],{"name":62,"role":39,"phone":63,"phoneExt":22,"email":64},"Sadie Walker, OTR","708-964-3805","sadie.walker@va.gov",{"name":43,"role":39,"phone":44,"phoneExt":22,"email":45},{"name":33,"role":35,"phone":22,"phoneExt":22,"email":22},{"type":68,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100559318","non-invasive-vns-for-parkinsons-gait-100559318",false,"NCT06562569","Non-invasive VNS for Parkinson's Gait","Stimulating the Vagus Nerve to Improve Gait in Veterans With Parkinson's Disease","Inclusion Criteria:\n\n* Parkinson's disease, as diagnosis by a VA neurologist\n* HY stages 2-3\n* Self-report Freezing of Gait\n* Able to ambulate for 2-min without an assistive device\n* Parkinson's disease medications are stable for 4-weeks and expected to be on stable medications for duration of the study\n\nExclusion Criteria:\n\nFor Group 1 and 2\n\n* Lack of decision-making capacity\n* Prescribed centrally acting anticholinergics (e.g., amitriptyline) or cholinesterase inhibitors\n* Musculoskeletal or additional neurological conditions that negatively impact gait and balance\n* Spine or LE surgery within the past year\n* Uncontrolled hypertension, hypotension, bradycardia, or tachycardia\n* History of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure, known severe coronary artery disease, severe carotid stenosis (e.g., bruits or history of TIA or stroke), or recent myocardial infarction (within 5 years).\n* Abnormal baseline electrocardiogram within last year\n* Previous vagotomy\n* Implanted metal cervical spine hardware, other metallic implants or implantable medical devices such as DBS\n* Active cancer\n* have previously had cancer in any areas where stimulation will occur\n* Documented abnormal cervical anatomy\n* History of brain tumor, aneurysm, bleed or head trauma\n* History of syncope or seizures (within the last 2 years)\n\nFor Group 3\n\n* Lack of decision-making capacity\n* Musculoskeletal or additional neurological conditions that negatively impact gait and balance\n* Spine or LE surgery within the past year","ALL","50 Years","88 Years",{"count":80,"type":81},40,"ESTIMATED","INTERVENTIONAL",[84],"NA","More than 110,000 US Veterans living with Parkinson's disease (PD) currently receive PD-related care and services from the VA. Fall prevention is a priority for Veterans living PD. Gait disturbances are a major cause for functional dependence and the largest risk factor for falls, institutionalization, and death in PD. This SPiRE addresses the need to advance nonpharmacological rehabilitative health care of Veterans and maximizing functional outcomes by developing a non-invasive, neuromodulatory transcutaneous cervical Vagal Nerve Stimulation as an at-home intervention to improve gait and balance. This pilot clinical trial will assist with future efforts and priorities of the VA to prolong independent living and quality of life by minimizing gait and balance dysfunction experienced by Veterans living with PD.",[87],"Parkinson's Disease",[89,90,91,92,93],"vagal nerve stimulation","gait","neuromodulation","Freezing of gait","Veteran","2026-07-07",{"date":96,"type":97},"2026-07-09","ACTUAL",{"date":99,"type":97},"2026-03-01",{"date":101,"type":81},"2027-04-01",{"name":5,"class":6},1]