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

NCT05683925 | Completed

• 1 other identifier: 012052/2020/2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Keywords

parkinson's disease; taVNS; motion sensors

Outcome Measures

Primary Outcomes (8)

• Arm Swing Velocity

  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

  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

  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

  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

  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

  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

  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

  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.

Study Arms (4)

baseline

NO INTERVENTION

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.

taVNS100

ACTIVE COMPARATOR

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

taVNS25

ACTIVE COMPARATOR

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

sVNS

SHAM COMPARATOR

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

Interventions

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.

Also known as: taVNS100

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.

Also known as: taVNS25

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.

Also known as: sVNS

sVNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Neurology Department, UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

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

Study Officials

• Maja Kojović, MD, PhD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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 - participants will not be told which is the active and which is the sham condition. Both taVNS and sVNS were applied through the Nemos® electrode. 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof.

Model Details: 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 preform iSAW during each condition twice in silence and twice while simultaneously performing calculations around.

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 13, 2023
• Study Start: September 1, 2022
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Upon request after study publication.
• Access Criteria: Data will be shared with researchers upon reasonable request.

Locations

SL (1)