[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06562569":3,"trial-entities:NCT06562569":111,"trial-summary:NCT06562569":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":43,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":15,"eligibility_criteria":52,"std_ages":75,"locations":78,"central_contacts":101,"overall_officials":107,"references":109,"see_also_links":110},"NCT06562569","E5133-P","Non-invasive VNS for Parkinson's Gait","Stimulating the Vagus Nerve to Improve Gait in Veterans With Parkinson's Disease","RECRUITING","2027-04-01","2026-07","2026-07-09","2026-03-01","VA Office of Research and Development","FED",false,"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.","More than 110,000 US Veterans living with Parkinson's disease (PD) currently receive PD-related care and services from the VA. PD is a complex chronic neurodegenerative multisystem disorder. Fall prevention is a priority for Veterans living with PD. Gait disturbances are a major cause for functional dependence and the largest risk factor for falls, institutionalization, and death in PD. Gait abnormalities are evident at the time of PD diagnosis and are one of the most disabling features of PD. They are also difficult aspects to treat as pharmacologic agents do not address the entire spectrum of gait abnormalities. Overall management of PD symptoms can be challenging due to pharmacological interactions and drug side effects. Developing a non-pharmacological and non-invasive therapeutic to improve gait and balance is a critical need for Veterans with PD who are managing complex chronic conditions. Moreover, advancing at-home rehabilitation is ideal for a population of geriatric Veterans who are facing mobility issues, managing multiple chronic conditions and who rely on caregiver support. Non-invasive cervical Vagal Nerve Stimulation (ncVNS) may be a solution. ncVNS is currently licensed to treat and prevent migraine and other headache syndromes and is covered by the VAH for these indications. ncVNS can be self-administered, daily, at home. A hand-held device is used to make contact to the left side of the neck so that the vagal nerve is stimulated. ncVNS decreases inflammation and oxidative stress through activation of the cholinergic anti-inflammatory pathway, which in turn can contribute to gait improvements in PD. One of the most debilitating gait deficits in PD is Freezing of Gait (FOG), an episodic failure to initiate or maintain walking, especially while turning. Given that FOG, along with falls, is related to cholinergic dysfunction, both might be reduced following ncVNS. Exciting, but limited research over the past decade indicates this neuromodulatory approach has the potential to improve gait features in PD. The objectives of this SPiRE are to develop a framework for an at-home ncVNS intervention, develop an appropriate control intervention for a future larger study and gather preliminary clinical outcome data on PD-specific features. The central hypotheses are that (i) a 4 week at-home active ncVNS intervention and a sham ncVNS control condition will be acceptable and feasible to complete and (ii) active ncVNS compared to both control ncVNS and treatment as usual (TAU), will lead to greater improvements in gait, FOG, balance and fall frequency. The proposed study is a pilot, prospective parallel group randomized control trial (RCT). Twenty participants will be randomized to 4 weeks of either active (n=10) or sham ncVNS (n=10). A third group (n=10) will not receive ncVNS but will continue with their treatment as usual (TAU). The investigators will examine acute, cumulative, and sustainable effects of ncVNS. Advancing non-pharmacologic treatments to improve gait dynamics is a critical need for Veterans with PD. Moreover, advancing at-home rehabilitation is ideal for a population of geriatric Veterans who are facing multiple issues including mobility. This SPiRE is strongly aligned with VA priorities to advance rehabilitative health care of Veterans and restore their physical function to improve QoL. If the aims are achieved, the investigators will have completed necessary first steps towards developing an at-home easy to use, neuromodulatory intervention that should translate to improved gait and balance and contribute to fewer falls. This project will yield preliminary data to support a VA Merit and move forward not only the field of noninvasive and nonpharmacological interventions for PD rehabilitation but also the general field of gait and balance rehabilitation.",[19],"Parkinson's Disease",[21,22,23,24,25],"vagal nerve stimulation","gait","neuromodulation","Freezing of gait","Veteran","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},40,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":41},"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.",[39,40],"Group 1","Group 2",[42],"VNS",[44],{"measure":45,"description":46,"timeFrame":47},"Stride Length","Quantitative gait analysis will be performed during a 15-meter instrumented 2-min walk test (2MWT) using the APDM Mobility Lab","baseline and 4 weeks",[],"ALL","50 Years","88 Years",{"inclusion":53,"exclusion":59,"raw_text":74},[54,55,56,57,58],"Parkinson's disease, as diagnosis by a VA neurologist","HY stages 2-3","Self-report Freezing of Gait","Able to ambulate for 2-min without an assistive device","Parkinson's disease medications are stable for 4-weeks and expected to be on stable medications for duration of the study",[60,61,62,63,64,65,66,67,68,69,70,71,72,73,60,62,63],"Lack of decision-making capacity","Prescribed centrally acting anticholinergics (e.g., amitriptyline) or cholinesterase inhibitors","Musculoskeletal or additional neurological conditions that negatively impact gait and balance","Spine or LE surgery within the past year","Uncontrolled hypertension, hypotension, bradycardia, or tachycardia","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).","Abnormal baseline electrocardiogram within last year","Previous vagotomy","Implanted metal cervical spine hardware, other metallic implants or implantable medical devices such as DBS","Active cancer","have previously had cancer in any areas where stimulation will occur","Documented abnormal cervical anatomy","History of brain tumor, aneurysm, bleed or head trauma","History of syncope or seizures (within the last 2 years)","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",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":80,"status":8,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":98},"Edward Hines Jr. VA Hospital, Hines, IL","Hines","Illinois","60141-3030","United States",[86,91,95],{"name":87,"role":88,"phone":89,"email":90},"Sadie Walker, OTR","CONTACT","708-964-3805","sadie.walker@va.gov",{"name":92,"role":88,"phone":93,"email":94},"Alexandria N Umbarger, BS","(708) 998-8213","alexandria.umbarger@va.gov",{"name":96,"role":97},"Sandra L. Kletzel, PhD BA","PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},41.85364,-87.8395,[102,106],{"name":103,"role":88,"phone":104,"email":105},"Sandra L Kletzel, PhD BA","(708) 202-5735","Sandra.Kletzel@va.gov",{"name":92,"role":88,"phone":93,"email":94},[108],{"name":96,"affiliation":80,"role":97},[],[],{"nct_id":4,"conditions":112,"biomarkers":114},[113],"Parkinson Disease",[],{"nct_id":4,"found":116,"summary":117,"prompt_version":126},true,{"design":118,"status":119,"heading":6,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an interventional study planning to enroll 40 participants. It will test the ncVNS device.","completed","This study is investigating a non-invasive cervical vagal nerve stimulation (ncVNS) device to help improve walking difficulties (gait) in people with Parkinson's disease. The ncVNS device is a small, handheld device that delivers a gentle electrical stimulus. Researchers want to see if using this device at home can help people with Parkinson's walk better and reduce their risk of falls. You may be able to join if you are a Veteran aged 50-88, have Parkinson's disease (stages 2-3), experience freezing of gait, and can walk for two minutes without help. Your Parkinson's medications must also be stable. The study will measure stride length to see if the device is successful. The current status of this study is unclear.","Participants will be followed for at least 4 weeks after starting the intervention.",118,"Participants will have their stride length measured at the beginning of the study and again after 4 weeks.","Not stated in the trial record.",[],"v2"]