Clinical trial 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
- This study aims to see if a non-invasive neck nerve stimulator can improve walking and balance in people with Parkinson's disease.
- Who it's for
- The study is looking for Veterans living with Parkinson's disease who have trouble walking or balancing.
- What's involved
- Participants will use a device at home that sends mild electrical signals to a nerve in the neck to help with movement.
- Time commitment
- The source text does not specify the total duration or the number of required visits.
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 is enrolling
- 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, but 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?
This study is enrolling now at Hines, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.