RecruitingNot ApplicableNCT07588191

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


Sponsor

Universidade da Coruña

Enrollment

46 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Conventional Physical therapy, Conventional Speech Therapy, and others for people with parkinson disease (pd) and transcutaneous vagal nerve stimulation (tvns). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscutaneous Electrical Nerve Stimulation (TENS) of Vagus Nerve

The tVNS will be performed at 200 microseconds, with frequencies ranging from 20 to 200 Hz (30 seconds/30 seconds) for 30 minutes, in the area innervated by the auricular branch of the vagus nerve (cymba concha and concha). The individually titrated intensity will be set above the sensory threshold (intense tingling sensation) but below the level of discomfort.

OTHERConventional Physical therapy

Physical therapy delivered to both groups consists of exercises aimed at posture alignment and body coordination, static and dynamic balance improvement, and gait quality. It will be delivered once a week, during a session of electrical stimulation.

OTHERConventional Speech Therapy

It will focus on the orofacial muscles, the acquisition of a diaphragmatic-abdominal breathing pattern that integrates breathing with vocal production, voice training with exercises that enhance vocal quality and prosody, articulation exercises to improve speech clarity, and swallowing training. It will be administered once a week, during one of the three electrical stimulation sessions.

DEVICESham Transcutaneous Electrical Stimulation of Vagus Nerve

The sham- tVNS will be performed at 200 microseconds, with frequencies ranging from 20 to 200 Hz (30 seconds/30 seconds) for 30 minutes, with electrodes placed on the earlobe, which lacks vagus nerve innervation. The individually titrated intensity will be set above the sensory threshold (intense tingling sensation) but below the level of discomfort.


Locations(1)

Association of Parkinson´s Disease Galicia- Coruña

A Coruña, Spain

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NCT07588191


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