Vagal nerve stimulation for Parkinson's (NCT07226284)
Improve gait via vagus nerve
- Trial ID
- NCT07226284
- Official Title
- The Effects of Vagus Nerve Stimulation on Intrinsic Lower Leg Spinal Motoneuron Excitability in Parkinson's Disease.
- Goal
- Improve gait via vagus nerve
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Minnesota
- Study Type
- INTERVENTIONAL
- Enrollment
- 75 participants
- Conditions
- PARKINSON DISEASE (Disorder), Parkinson's Disease (PD)
- Interventions
- Vagal nerve stimulation, No intervention
Summary For Families
It tests whether non-invasive vagus nerve stimulation can change the excitability of spinal motor neurons that control the lower leg, a change that might improve gait and leg control in Parkinson's. The approach uses a handheld neck stimulator that sends brief electrical pulses to vagal afferents, which influence brainstem and spinal circuits and can alter reflexes and muscle activation; it is studied as a neuromodulation add-on while participants stay on their usual Parkinson's medications, not as a replacement for levodopa. The study wants adults 21 to 76 with idiopathic Parkinson's who can walk more than 50 meters without an assistive device and who have been on stable Parkinson's meds, plus an age and sex matched control group. People with significant heart disease or abnormal ECGs, implanted electronic or nearby metallic devices like DBS or pacemakers, recent seizures or syncope, neck wounds or prior neck surgery, or pregnancy are excluded.
Locations
- Movement Disorders Laboratory, Minneapolis, Minnesota, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Vagal nerve stimulation. It tests whether non-invasive vagus nerve stimulation can change the excitability of spinal motor neurons that control the lower leg, a change that might improve gait and leg control in Parkinson's. The approach uses a handheld neck stimulator that sends brief electrical pulses to vagal afferents, which influence brainstem and spinal circuits and can alter reflexes and muscle activation; it is studied as a neuromodulation add-on while participants stay on their usual Parkinson's medications, not as a replacement for levodopa. The study wants adults 21 to 76 with idiopathic Parkinson's who can walk more than 50 meters without an assistive device and who have been on stable Parkinson's meds, plus an age and sex matched control group. People with significant heart disease or abnormal ECGs, implanted electronic or nearby metallic devices like DBS or pacemakers, recent seizures or syncope, neck wounds or prior neck surgery, or pregnancy are excluded.
- Who can participate?
- Participants must be between 21 Years and 76 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 11 months.
- 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 is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. It also includes a placebo or sham phase, so you would be on that during another period. Ask the coordinator for the exact sequence and how long each phase lasts.