NCT07588191Active, not recruiting
Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease
Effects of Transcutaneous Stimulation of the Auricular Branch of the Vagus Nerve in Parkinson´s Disease
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
This study aims to determine whether electrical stimulation of the ear, when combined with physical and speech therapy, can improve symptoms in subjects diagnosed with Parkinson´s disease, by comparing two different application sites. Each subject will undergo an initial in-person screening and provide consent before participating in the study. The main questions to answer are: * Does transcutaneous electrical nerve stimulation (tVNS) in the ear paired with physical and speech therapy improve speech and voice-related problems, airway protection, salivation, and swallowing? * Does tVNS paired with physical and speech therapy improve tremor, walking speed, and balance in people with PD? * Does tVNS paired with physical and speech therapy improve heart rate and heart rate variability in people with PD? * Do its effects persist at 8 weeks? Participants will: Attend 12 rehabilitation sessions over 4 weeks (three per week). During each session, participants received either active or sham tVNS, accompanied by speech therapy (once per week), physical therapy (once per week), or conducted alone (once per week). Undergo speech, voice, swallowing, respiratory, gait, balance, tremor, heart rate variability, and cognitive testing, as well as questionnaires regarding the quality of life, before and after treatment. Return for a follow-up visit eight weeks after therapy to check how long the effects last.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 23 Apr 2026
- Start date
- 25 May 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Universidade da Coruña
- Diseases
- Parkinson disease
- NCT number
- NCT07588191
What you commit to
- Study type: Interventional
- Planned participants: 46
- From 25 May 2026 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous vagotomy or previous application of electrical stimulation to the ear or brain, or treatment with high-intensity focused ultrasound (HIFU)
- Concomitant neurological, orthopaedic, cardiac, respiratory or active medical/oncological condition that would affect participation
Other illness
- Voice or speech disorders caused by other medical conditions
- Psychotic symptoms or hallucinations; a diagnosis of psychiatric illness
Other
- Any contraindication for taVNS (e.g., ear lesions, pacemakers, defibrillators, or other electronic devices)
- MoCA score below 21
- Systolic blood pressure above 160 mm Hg, and diastolic blood pressure above 100 mm Hg
- Inability to attend sessions;
Who the study is looking for
- Being a member of the Association or be interested in joining;
- Idiopathic PD diagnosis, stages 2-3 according to the Hoehn \& Yahr scale; confirmed by neurologist
- Ability to walk independently for at least 1 minute ant turn 180° without assistance;
- Exhibiting symptoms of hypokinetic dysarthria;
- On stable dopaminergic therapy for at least 1 month prior to the experiment
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Association of Parkinson´s Disease Galicia- Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.