non-invasive cervical vagal nerve… for Parkinson's (NCT06562569)
Home neck stimulation improves walking
- Trial ID
- NCT06562569
- Official Title
- Stimulating the Vagus Nerve to Improve Gait in Veterans With Parkinson's Disease
- Goal
- Home neck stimulation improves walking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- VA Office of Research and Development
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson's Disease
- Interventions
- non-invasive cervical vagal nerve stimulation ncVNS
Summary For Families
They're testing whether gentle electrical stimulation of the vagus nerve can reduce freezing of gait and improve walking and balance in veterans with Parkinson's. A small, non-invasive device is placed on the side of the neck and delivers short electrical pulses through the skin to activate vagal pathways that influence motor control, attention, and balance, it is used alongside usual Parkinson's medications rather than replacing levodopa and participants must stay on stable meds. Eligible volunteers are age 50 to 88, have Parkinson's at Hoehn and Yahr stages 2 or 3, report freezing of gait, and can walk for two minutes without an assistive device, with meds stable for at least four weeks. People with serious heart or carotid disease, implanted metal or devices such as DBS, recent spine or leg surgery, recent seizures or syncope, or who take certain medicines like anticholinergics or cholinesterase inhibitors are excluded.
Locations
- Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying non-invasive cervical vagal nerve stimulation ncVNS. They're testing whether gentle electrical stimulation of the vagus nerve can reduce freezing of gait and improve walking and balance in veterans with Parkinson's. A small, non-invasive device is placed on the side of the neck and delivers short electrical pulses through the skin to activate vagal pathways that influence motor control, attention, and balance, it is used alongside usual Parkinson's medications rather than replacing levodopa and participants must stay on stable meds. Eligible volunteers are age 50 to 88, have Parkinson's at Hoehn and Yahr stages 2 or 3, report freezing of gait, and can walk for two minutes without an assistive device, with meds stable for at least four weeks. People with serious heart or carotid disease, implanted metal or devices such as DBS, recent spine or leg surgery, recent seizures or syncope, or who take certain medicines like anticholinergics or cholinesterase inhibitors are excluded.
- Who can participate?
- Participants must be between 50 Years and 88 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has a group that receives no study treatment (you would continue your usual care) alongside the treatment groups. Because assignment is random, you have about a 1 in 3 chance (roughly 33%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.