Clinical trial NCT05683925: Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Characteristics in Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Gait Disorders, Neurologic
Keywords: parkinson's disease
taVNS
motion sensors
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model 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 preform iSAW during each condition twice in silence and twice while simultaneously performing calculations around.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Arm Swing Velocity
timeFrame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
measure: Arm Range of Motion
timeFrame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
measure: Stride Length
timeFrame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
measure: Gait Speed
timeFrame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
measure: Arm Range of Motion Asymmetry
timeFrame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
measure: Anticipatory Postural Adjustment (APA) duration
timeFrame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
measure: APA First step Duration
timeFrame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
measure: APA First Step range of motion
timeFrame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Neurology Department, UMC Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Maja Kojović, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: