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Effects of Transcutaneous Stimulation of the Auricular Branch of the Vagus Nerve in Parkinson´s Disease

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Association of Parkinson´s Disease Galicia- Coruña
RECRUITING
A Coruña
Contact Information
Primary
Alicia Martínez-Rodríguez alicia.martinez@udc.es, Lecturer
alicia.martinez@udc.es
+34 881015851
Backup
Olalla Bello, Lecturer
olalla.bello@udc.es
+34 881015852
Time Frame
Start Date: 2026-05
Estimated Completion Date: 2026-11
Participants
Target number of participants: 46
Treatments
Active_comparator: Active tVNS paired with conventional Speech Therapy and Physical Therapy
Participants in this arm will receive transcutaneous electrical stimulation applied to the concha of the left ear for 30 minutes, three times a week, over a 4-week period. This location is known to be innervated by the auricular branch of the vagus nerve. In addition, a speech therapy session and a physical therapy session will be added once a week each, while receiving the electrical stimulation.
Sham_comparator: Sham tVNS paired with Speech Therapy and Physical Therapy
Participants in this arm will receive the same transcutaneous electrical stimulation as the active group, but applied to the earlobe, a site not innervated by the vagus nerve. The procedure, the appearance of the device, and the parameters are identical to those of the active condition to maintain participant blinding. In addition, a speech therapy session and a physical therapy session will be added once a week each, while receiving the electrical stimulation.
Sponsors
Collaborators: Parkinson´s Association Galicia-Coruña
Leads: Universidade da Coruña

This content was sourced from clinicaltrials.gov