NCT07588191 Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease
| NCT ID | NCT07588191 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidade da Coruña |
| Condition | Transcutaneous Vagal Nerve Stimulation (tVNS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2026-05 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 46 participants in total. It began in 2026-05 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Any contraindication for taVNS (e.g., ear lesions, pacemakers, defibrillators, or other electronic devices) * Previous vagotomy or previous application of electrical stimulation to the ear or brain, or treatment with high-intensity focused ultrasound (HIFU) * Voice or speech disorders caused by other medical conditions * MoCA score below 21 * Psychotic symptoms or hallucinations; a diagnosis of psychiatric illness * Systolic blood pressure above 160 mm Hg, and diastolic blood pressure above 100 mm Hg * Inability to attend sessions; * Concomitant neurological, orthopaedic, cardiac, respiratory or active medical/oncological condition that would affect participation
Contact & Investigator
Alicia Martínez-Rodríguez, Lecrurer
PRINCIPAL INVESTIGATOR
Universidade da Coruña
Frequently Asked Questions
Who can join the NCT07588191 clinical trial?
This trial is open to participants of all sexes, studying Transcutaneous Vagal Nerve Stimulation (tVNS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07588191 currently recruiting?
Yes, NCT07588191 is actively recruiting participants. Contact the research team at alicia.martinez@udc.es for enrollment information.
Where is the NCT07588191 trial being conducted?
This trial is being conducted at A Coruña, Spain.
Who is sponsoring the NCT07588191 clinical trial?
NCT07588191 is sponsored by Universidade da Coruña. The principal investigator is Alicia Martínez-Rodríguez, Lecrurer at Universidade da Coruña. The trial plans to enroll 46 participants.