Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Characteristics in Parkinson's Disease

October 16, 2023 updated by: Maja Kojović, University Medical Centre Ljubljana

Effect of Transcutaneous Auricular Vagus Nerve Stimulation at 25Hz and 100Hz on Levodopa Responsive and Non-responsive Gait Characteristics in Parkinson's Disease- a Motion Sensor Study

In this randomised placebo-controlled trial, the investigators will include 30 PD (Parkinson's disease) patients with HY (Hoehn Yahr stage) >2 and L-dopa unresponsive gait characteristics. Each participant will receive taVNS at 25Hz, taVNS at 100Hz and sham VNS (sVNS). During each stimulation, different gait characteristics will be measured with wearable insertion motion sensors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants and study overview:

In this randomised placebo-controlled trial, the investigators will include 30 PD patients with HY>2 and L-dopa unresponsive gait characteristics. Each participant will complete 1 visit, during which the instrumented stand and walk test will be repeated 16 times. The baseline measurement will be followed by three different stimulation conditions sham VNS (sVNS), taVNS at 25Hz (taVNS25) and taVNS a 100Hz (taVNS100). sVNS, taVNS25 and taVNS100 in a randomized order. To enhance gait disturbances, the participants will perform iSAW during each condition twice in silence and twice while simultaneously performing calculations around.

Instrumented stand and walk test (iSAW):

To perform iSAW, participants will first stand still for 30s, after which they will start walking in a straight line for 7m, turn and walk back to the start. The participants will be equipped with 6 inertion Opal ® motion sensors (on both feet, both wrists, on the lumbar back and on their sternum). For the laud counting iSAW condition (iSAW-C), the participants will perform iSAW as described above while also counting backwards by 3 from numbers above 100.

TaVNS:

Noninvasive electrostimulation will be applied to the left ear. taVNS will be applied to the cyma conchae and sVNS will be applied to the earlobe. Both taVNS and sVNS were applied 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 (figure 1). taVNS25 and sVNS will be applied at 25Hz and taVNS100 will be applied at 100Hz. The intensity for each separate stimulation will be adjusted for each participant at the beginning of the experiment. For each condition, the electrode will be placed in the ear by a third person and the ear will be covered by cotton pads and an EEG cap to hide the electrode position from the experimenter. The order of stimulation will not be revealed until the automated data and statistical analysis.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Neurology Department, UMC Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • HYstage >2
  • L-dopa unresponsive gait characteristics present, preferably with history of freezings

Exclusion Criteria:

  • unable to walk for 50m
  • unable to follow simple commands due to hearing loss/cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: baseline
Participants will receive no stimulation, the electrode will be placed in the ear in a random position and turned off. Participants will complete 4 instrumented stand and walk tests - 2 without performing calculations and 2 with performing calculations aloud.
Active Comparator: taVNS100
Noninvasive electrostimulation will be applied to the left cyma conchae through the Nemos® electrode at 100Hz. Participants will complete 4 instrumented stand and walk tests - 2 without performing calculations and 2 with performing calculations aloud.
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.
Other Names:
  • taVNS100
Active Comparator: taVNS25
Noninvasive electrostimulation will be applied to the left cyma conchae through the Nemos® electrode at 25Hz. Participants will complete 4 instrumented stand and walk tests - 2 without performing calculations and 2 with performing calculations aloud.
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.
Other Names:
  • taVNS25
Sham Comparator: sVNS
Noninvasive electrostimulation will be applied to the left earlobe through the Nemos® electrode at 25Hz. Participants will complete 4 instrumented stand and walk tests - 2 without performing calculations and 2 with performing calculations aloud.
Device: Noninvasive transcutaneous earlobe stimulation at 25Hz
Noninvasive electrostimulation will be applied to the left earlobe 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.
Other Names:
  • sVNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arm Swing Velocity
Time Frame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average velocity of upper extremities in degrees per second as produced by the Mobility Lab software.
This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
Arm Range of Motion
Time Frame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average wrist range of motion in degrees as produced by the Mobility Lab software.
This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
Stride Length
Time Frame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average stride length in m as produced by the Mobility Lab software.
This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
Gait Speed
Time Frame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average speed of gait in m/s as produced by the Mobility Lab software.
This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
Arm Range of Motion Asymmetry
Time Frame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average difference between left and right arm range of motion in degrees as produced by the Mobility Lab software.
This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
Anticipatory Postural Adjustment (APA) duration
Time Frame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average duration of anticipatory postural adjustments in seconds as produced by the Mobility Lab software.
This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
APA First step Duration
Time Frame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average duration of the first detected step in seconds as produced by the Mobility Lab software.
This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
APA First Step range of motion
Time Frame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average range of motion of the first detected step as produced by the Mobility Lab software.
This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Principal Investigator: Maja Kojović, MD, PhD, University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

February 15, 2023

Study Completion (Actual)

February 15, 2023

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012052/2020/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators plan to share the anonymised data with researchers upon request.

IPD Sharing Time Frame

Upon request after study publication.

IPD Sharing Access Criteria

Data will be shared with researchers upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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