| NCT ID | NCT06562569 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Known or suspected: * severe atherosclerotic cardiovascular disease * severe carotid artery disease * congestive heart failure * known severe coronary artery disease or prior myocardial infarction * Abnormal baseline electrocardiogram within last year * Previous vagotomy * Implanted metal cervical spine hardware, other metallic implants or implantable medical devices such as DBS * History of syncope or seizures (within the last 2 years)
Contact & Investigator
Sandra L. Kletzel, PhD BA
PRINCIPAL INVESTIGATOR
Edward Hines Jr. VA Hospital, Hines, IL
Frequently Asked Questions
Who can join the NCT06562569 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 88 Years, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06562569 currently recruiting?
Yes, NCT06562569 is actively recruiting participants. Contact the research team at Sandra.Kletzel@va.gov for enrollment information.
Where is the NCT06562569 trial being conducted?
This trial is being conducted at Hines, United States.
Who is sponsoring the NCT06562569 clinical trial?
NCT06562569 is sponsored by VA Office of Research and Development. The principal investigator is Sandra L. Kletzel, PhD BA at Edward Hines Jr. VA Hospital, Hines, IL. The trial plans to enroll 40 participants.
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