Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversidade da Coruña

About this trial

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

Qualifiers

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;

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Transcutaneous Electrical Nerve Stimulation (TENS) of Vagus Nerve
  • Conventional Physical therapy
  • Conventional Speech Therapy
  • Sham Transcutaneous Electrical Stimulation of Vagus Nerve

Treatment groups

46 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universidade da Coruña

Lead sponsor

Parkinson´s Association Galicia-Coruña

Collaborator