Actively Recruiting
Effects of Transcutaneous Stimulation of the Auricular Branch of the Vagus Nerve in Parkinson's Disease
Led by Universidade da Coruña · Updated on 2026-05-19
46
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
Universidade da Coruña
Lead Sponsor
P
Parkinson´s Association Galicia-Coruña
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether electrical stimulation of the ear, combined with physical and speech therapy, can improve both motor and non-motor symptoms in people diagnosed with Parkinson's disease (PD). The trial is a double-blind, randomized, controlled study investigating the effects of transcutaneous auricular vagus nerve stimulation (tVNS) on symptoms such as speech and voice problems, swallowing, tremor, walking, balance, heart rate variability, and overall quality of life. Up to 46 participants with PD stages 2-3 will be involved, with assessments guided by clinical scales and voice variables. Participants will attend 12 rehabilitation sessions over 4 weeks, receiving 30-minute electrical stimulation three times per week. One group will have stimulation applied to the cymba concha of the ear, where the vagus nerve is located, while the other group will receive sham stimulation on the earlobe, which is not innervated by the vagus nerve. Speech therapy and physical therapy sessions will be given once a week alongside the stimulation. The intensity of the stimulation is individually adjusted to be noticeable but comfortable. Before treatment, after 4 weeks, and 8 weeks post-treatment, participants will undergo evaluations including speech, voice, swallowing, respiratory, gait, balance, tremor, heart rate variability, cognitive testing, and quality of life questionnaires. Researchers will monitor the effects during the intervention and assess how long benefits last. Safety and tolerance will also be evaluated during the 4-week therapy period, with ongoing data collection at multiple timepoints.
CONDITIONS
Brief Title
Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be a member of the Association or interested in joining
- Diagnosed with idiopathic Parkinson's disease, stages 2-3 by Hoehn & Yahr scale, confirmed by a neurologist
- Able to walk independently for at least 1 minute and turn 180° without assistance
- Show symptoms of hypokinetic dysarthria
- On stable dopaminergic therapy for at least 1 month before the study
You will not qualify if you...
- Contraindications for transcutaneous auricular vagus nerve stimulation (e.g., ear lesions, pacemakers, defibrillators, or other electronic devices)
- Previous vagotomy or prior electrical stimulation to ear or brain, or treatment with high-intensity focused ultrasound
- Voice or speech disorders caused by other medical conditions
- Montreal Cognitive Assessment (MoCA) score below 21
- Psychotic symptoms, hallucinations, or psychiatric illness diagnosis
- Systolic blood pressure above 160 mm Hg or diastolic above 100 mm Hg
- Unable to attend study sessions
- Neurological, orthopedic, cardiac, respiratory, or active medical/oncological conditions affecting participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive transcutaneous electrical stimulation of the auricular branch of the vagus nerve or sham stimulation on the earlobe for 30 minutes, three times weekly over 4 weeks. Alongside, they participate in physical therapy and speech therapy sessions once per week each during stimulation.
Three visits per week for stimulation sessions; 1 physical therapy session and 1 speech therapy session each week during stimulation
Duration - 8 weeks post-intervention
Participants are assessed 8 weeks after finishing the intervention to evaluate the lasting effects of the treatment on voice, motor, cognitive, and quality of life measures.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Association of Parkinson´s Disease Galicia- Coruña
A Coruña, Spain, 15008
Actively Recruiting
Research Team
A
Alicia Martínez-Rodríguez alicia.martinez@udc.es, Lecturer
O
Olalla Bello, Lecturer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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