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

Parkinson Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05683925
• Other study ID #: 012052/2020/2
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: October 2023
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Slovenia	Neurology Department, UMC Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.