Improve speech clarity and walking
- Trial ID
- NCT07588191
- Official Title
- Effects of Transcutaneous Stimulation of the Auricular Branch of the Vagus Nerve in Parkinson´s Disease
- Goal
- Improve speech clarity and walking
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Universidade da Coruña
- Study Type
- INTERVENTIONAL
- Enrollment
- 46 participants
- Conditions
- Transcutaneous Vagal Nerve Stimulation (tVNS), Parkinson Disease (PD)
- Interventions
- Transcutaneous Electrical Nerve Stimulation (TENS) of Vagus Nerve, Conventional Physical therapy, Conventional Speech Therapy, Sham Transcutaneous Electrical Stimulation of Vagus Nerve
Summary For Families
They want to see if gentle electrical stimulation of the ear branch of the vagus nerve can improve hypokinetic dysarthria and related motor symptoms in people with mid-stage Parkinson's. The approach uses noninvasive transcutaneous vagus nerve stimulation, sending small electrical pulses to the auricular branch at the ear to modulate brain networks involved in speech and movement, delivered alongside conventional physical and speech therapy with a sham group for comparison; it is added to, not a replacement for, your regular dopaminergic meds. The trial is looking for people with idiopathic PD at Hoehn and Yahr stages 2 to 3 who have hypokinetic dysarthria, can walk independently for at least one minute and turn 180 degrees, are on stable dopaminergic therapy, and who do not have pacemakers, ear lesions, prior vagotomy, severe psychiatric illness, very high blood pressure, or a MoCA score under 21.
Locations
- Association of Parkinson´s Disease Galicia- Coruña, A Coruña, Spain
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Transcutaneous Electrical Nerve Stimulation (TENS) of Vagus Nerve. They want to see if gentle electrical stimulation of the ear branch of the vagus nerve can improve hypokinetic dysarthria and related motor symptoms in people with mid-stage Parkinson's. The approach uses noninvasive transcutaneous vagus nerve stimulation, sending small electrical pulses to the auricular branch at the ear to modulate brain networks involved in speech and movement, delivered alongside conventional physical and speech therapy with a sham group for comparison; it is added to, not a replacement for, your regular dopaminergic meds. The trial is looking for people with idiopathic PD at Hoehn and Yahr stages 2 to 3 who have hypokinetic dysarthria, can walk independently for at least one minute and turn 180 degrees, are on stable dopaminergic therapy, and who do not have pacemakers, ear lesions, prior vagotomy, severe psychiatric illness, very high blood pressure, or a MoCA score under 21.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- 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 4 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.