Transcutaneous auricular vagus ner… for Parkinson's (NCT06409338)
Improve movement with ear stimulation
- Trial ID
- NCT06409338
- Official Title
- Research on the Brain Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in Regulating PD Motor Symptoms
- Goal
- Improve movement with ear stimulation
- Phase
- NA
- Status
- UNKNOWN
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Study Type
- INTERVENTIONAL
- Enrollment
- 32 participants
- Conditions
- Parkinson Disease
- Interventions
- Transcutaneous auricular vagus nerve stimulation (active）, Transcutaneous auricular vagus nerve stimulation (sham）
Summary For Families
Researchers are testing whether noninvasive stimulation of a branch of the vagus nerve in the ear can improve Parkinson's movement problems by restoring the balance between overactivity and underactivity in the brain area that controls movement. In a double blind comparison, half of the participants had 14 consecutive days of active ear stimulation, twice daily for 30 minutes, while the other half had sham stimulation with electrodes placed on the left earlobe. Movement symptoms and brain activity were measured before the treatment and one day after using functional near-infrared spectroscopy and transcranial magnetic stimulation. The trial seeks people aged 40 to 80 with early-stage Parkinson's (stage 2 or lower while on medication), on stable Parkinson's medicines for at least a month, without significant thinking or memory problems (Montreal Cognitive Assessment score 24 or higher), severe tremor or levodopa-induced involuntary movements, recent vagus nerve stimulation, or major medical illnesses.
Locations
- the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Transcutaneous auricular vagus nerve stimulation (active）. Researchers are testing whether noninvasive stimulation of a branch of the vagus nerve in the ear can improve Parkinson's movement problems by restoring the balance between overactivity and underactivity in the brain area that controls movement. In a double blind comparison, half of the participants had 14 consecutive days of active ear stimulation, twice daily for 30 minutes, while the other half had sham stimulation with electrodes placed on the left earlobe. Movement symptoms and brain activity were measured before the treatment and one day after using functional near-infrared spectroscopy and transcranial magnetic stimulation. The trial seeks people aged 40 to 80 with early-stage Parkinson's (stage 2 or lower while on medication), on stable Parkinson's medicines for at least a month, without significant thinking or memory problems (Montreal Cognitive Assessment score 24 or higher), severe tremor or levodopa-induced involuntary movements, recent vagus nerve stimulation, or major medical illnesses.
- Who can participate?
- Participants must be between 40 Years and 80 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 3 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 trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Participants attend fourteen consecutive daily sessions and have assessments performed two times: at baseline and one day post intervention.