Non-invasive VNS for Parkinson's Disease Gait Issues
Non-invasive VNS for Parkinson's Gait
Recruiting
N/AInterventional Study
Parkinson's Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 88
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for Veterans with Parkinson's disease who have problems walking. Participants will use a non-invasive device at home to help improve their gait and balance.
Are You a Good Fit for This Trial?
Must not be takingCentrally acting anticholinergics
Rules you outUncontrolled hypertensionHistoric heart diseaseActive cancer
You may be able to join if
I have been diagnosed with Parkinson's disease by a VA neurologist.
I am in stages 2-3 of the Hoehn and Yahr scale.
I experience Freezing of Gait.
I can walk for 2 minutes without assistance.
My Parkinson's disease medications have been stable for 4 weeks.
You may not be able to join if
I cannot make medical decisions for myself.
I take medications that affect my nervous system like anticholinergics.
I have other conditions that negatively impact my gait and balance.
I have had spine or lower extremity surgery in the past year.
I have uncontrolled high or low blood pressure.
I have a history of heart disease, stroke, or certain severe cardiovascular issues.
I have had abnormal heart tests in the last year.
I have active cancer or have had cancer in areas where stimulation will happen.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 heal…
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.
Trial Locations
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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 s…
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:
For Group 1 and 2
* 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)
For Group 3
* Lack of decision-making capacity
* Musculoskeletal or additional neurological conditions that negatively impact gait and balance
* Spine or LE surgery within the past year
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