Parkinson DiseaseNCT05683925
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Characteristics in Parkinson's Disease
A study testing Noninvasive transcutaneous auricular vagus nerve stimulation at 100Hz, Noninvasive transcutaneous auricular vagus nerve stimulation at 25Hz and Noninvasive transcutaneous earlobe stimulation at 25Hz in people with Parkinson Disease and Gait Disorders, Neurologic, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic
- What is being tested?
- Noninvasive transcutaneous auricular vagus nerve stimulation at 100Hz, Noninvasive transcutaneous auricular vagus nerve stimulation at 25Hz and Noninvasive transcutaneous earlobe stimulation at 25Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2022to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HYstage >2
- L-dopa unresponsive gait characteristics present, preferably with history of freezings
Who cannot join
- unable to walk for 50m
- unable to follow simple commands due to hearing loss/cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Being tested
- Noninvasive transcutaneous auricular vagus nerve stimulation at 100Hz, Noninvasive transcutaneous auricular vagus nerve stimulation at 25Hz, Noninvasive transcutaneous earlobe stimulation at 25Hz
- Keywords
- parkinson's disease, taVNS, motion sensors
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive transcutaneous auricular vagus nerve stimulation at 100HzDevice
Also called taVNS100
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 25HzDevice
Also called taVNS25
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 25HzDevice
Also called sVNS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Noninvasive transcutaneous earlobe stimulation at 25Hz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Swing Velocity
The average velocity of upper extremities in degrees per second as produced by the Mobility Lab software.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Sep 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja Kojović, University Medical Centre Ljubljana
- Investigators
- Maja Kojović, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683925
- Sponsor's protocol ID
- 012052/2020/2
- Status last verified
- Oct 2023
- First submitted
- 19 Dec 2022
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share the anonymised data with researchers upon request.
Publications
van Midden V, Simoncic U, Pirtosek Z, Kojovic M. The Effect of taVNS at 25 Hz and 100 Hz on Parkinson's Disease Gait-A Randomized Motion Sensor Study. Mov Disord. 2024 Aug;39(8):1375-1385. doi: 10.1002/mds.29826. Epub 2024 May 17.
PubMed 38757756
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05683925
- Acronym / sponsor ID
- 012052/2020/2
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Keywords
- parkinson's disease, taVNS, motion sensors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Noninvasive transcutaneous auricular vagus nerve stimulation at 100HzNoninvasive 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. |
| taVNS25 | Active comparator | Device: Noninvasive transcutaneous auricular vagus nerve stimulation at 25HzNoninvasive 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. |
| sVNS | Sham comparator | Device: Noninvasive transcutaneous earlobe stimulation at 25HzNoninvasive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HYstage >2
- L-dopa unresponsive gait characteristics present, preferably with history of freezings
Key exclusion criteria (2 listed)
- unable to walk for 50m
- unable to follow simple commands due to hearing loss/cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive transcutaneous auricular vagus nerve stimulation at 100HzAlso: taVNS100Noninvasive 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. | Device | taVNS100 |
| Noninvasive transcutaneous auricular vagus nerve stimulation at 25HzAlso: taVNS25Noninvasive 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. | Device | taVNS25 |
| Noninvasive transcutaneous earlobe stimulation at 25HzAlso: sVNSNoninvasive 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. | Device | sVNS |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Derived from this study: PubMed 38757756van Midden V, Simoncic U, Pirtosek Z, Kojovic M. The Effect of taVNS at 25 Hz and 100 Hz on Parkinson's Disease Gait-A Randomized Motion Sensor Study. Mov Disord. 2024 Aug;39(8):1375-1385. doi: 10.1002/mds.29826. Epub 2024 May 17.
- Individual participant dataSharing planned: Yes. The investigators plan to share the anonymised data with researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maja Kojović, MD, PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive transcutaneous auricular vagus nerve stimulation at 100Hz, Noninvasive transcutaneous auricular vagus nerve stimulation at 25Hz and Noninvasive transcutaneous earlobe stimulation at 25Hz in people with Parkinson Disease and Gait Disorders, Neurologic, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm Swing Velocity (time frame: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05683925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.