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New treatment option for Parkinson's Disease
Official title Non-invasive VNS for Parkinson's Gait
ClinicalTrials.gov ID: NCT06562569
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 88
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hines, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 88 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hines, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.