Transcutaneous Electrical Nerve St… for Parkinson's (NCT07588191)
Improve voice and swallowing function
- Trial ID
- NCT07588191
- Official Title
- Effects of Transcutaneous Stimulation of the Auricular Branch of the Vagus Nerve in Parkinson´s Disease
- Goal
- Improve voice and swallowing function
- 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
The goal is to see whether gentle electrical stimulation of the ear, given together with regular physical and speech therapy, can improve voice and speech, swallowing and saliva control, walking, balance, tremor, and heart rate measures in people with Parkinson's. The approach is 12 supervised rehab sessions over 4 weeks, each with 30 minutes of either real or sham ear stimulation while participants also receive one weekly speech session and one weekly physical session; one group gets stimulation at an ear spot where the vagus nerve is located and the other gets sham stimulation at the earlobe. Researchers will measure voice, swallowing, breathing, walking, balance, tremor, heart rate variability, cognition, and quality of life before treatment, right after 4 weeks, and again 8 weeks later to see how long any effects last. The study is looking for people diagnosed with Parkinson's by a neurologist at middle stages (Hoehn and Yahr stages 2, 3) who can walk independently for at least one minute, have Parkinson's-related speech problems, and have been on stable Parkinson medication for at least one month.
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. The goal is to see whether gentle electrical stimulation of the ear, given together with regular physical and speech therapy, can improve voice and speech, swallowing and saliva control, walking, balance, tremor, and heart rate measures in people with Parkinson's. The approach is 12 supervised rehab sessions over 4 weeks, each with 30 minutes of either real or sham ear stimulation while participants also receive one weekly speech session and one weekly physical session; one group gets stimulation at an ear spot where the vagus nerve is located and the other gets sham stimulation at the earlobe. Researchers will measure voice, swallowing, breathing, walking, balance, tremor, heart rate variability, cognition, and quality of life before treatment, right after 4 weeks, and again 8 weeks later to see how long any effects last. The study is looking for people diagnosed with Parkinson's by a neurologist at middle stages (Hoehn and Yahr stages 2, 3) who can walk independently for at least one minute, have Parkinson's-related speech problems, and have been on stable Parkinson medication for at least one month.
- 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.
- 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?
- You will have an initial in-person screening, attend 12 rehabilitation sessions over 4 weeks (three per week), and return for a follow-up visit eight weeks after therapy.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.