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Completed

NCT Number: NCT05683925

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Gait Disorders, Neurologic Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurology Department, UMC Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noninvasive transcutaneous auricular vagus nerve stimulation at 100Hz

Device

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

Noninvasive transcutaneous auricular vagus nerve stimulation at 25Hz

Device

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

Noninvasive transcutaneous earlobe stimulation at 25Hz

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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