Effect of taVNS of Brainstem Activation in Early and Late Parkinson's Disease Patients - an fMRI Study

Summary

This is a randomised, within-subject, double-blinded, placebo-controlled study to assess the fMRI correlates of central nervous system (CNS) response to taVNS in early vs late-stage Parkinsons disease (PD), at two different frequencies. Forty PD patients will be included: twenty patients with early-stage (Hoehn and Yahr stage (HY) 1-2) and twenty patients with late-stage (HY 3-4) PD. Each patient will undergo one stimulation session, where they will receive active taVNS at 100 Hz (taVNS100), taVNS at 25Hz (taVNS25) or will have positioned electrodes without stimulation (xVNS). The order of taVNS100, taVNS25 and xVNS will be randomized between subjects. The session will include (1) xVNS and taVNS; (2) MRI and fMRI and (3) heart rate and breathing rate monitoring. Clinical assessment with the Movement Disorder Society-Unified Parkinson's Disease Rating Scale will be done before the session.

Conditions

• Parkinson Disease
• Neurologic Disorder

Interventions

DEVICE

Noninvasive transcutaneous auricular vagus nerve stimulation at 100Hz

Noninvasive electrostimulation will be applied to the left cyma conchae through the Nemos® electrode with the following parameters: square-shaped pseudobiphasic pulse, interpulse duration 80μs, pulse width 300μs, pulse intensity 0,1mA above the perceptual threshold at 100Hz. The intensity for each separate stimulation will be adjusted for each participant at the beginning of the experiment

DEVICE

Noninvasive transcutaneous auricular vagus nerve stimulation at 25Hz

Noninvasive electrostimulation will be applied to the left cyma conchae through the Nemos® electrode with the following parameters: square-shaped pseudobiphasic pulse, interpulse duration 80μs, pulse width 300μs, pulse intensity 0,1mA above the perceptual threshold at 25Hz. The intensity for each separate stimulation will be adjusted for each participant at the beginning of the experiment.

DEVICE

Sham cyma conchae stimulation

The electrode will be placed at the cymba conchae location, however no electrical current will be applied. All other experimental conditions will be the same as for the active taVNS stimulation.

Sponsors & Collaborators

• University Medical Centre Ljubljana

  collaborator OTHER

• University of Ljubljana

  lead OTHER

Principal Investigators

• Andrej Vovk, PhD · Medical Faculty, University of Ljubljana

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-15

Primary Completion

2023-09-29

Completion

2023-09-29

Countries

• Slovenia

Study Locations