Parkinson DiseaseNCT05967598
Effect of taVNS of Brainstem Activation in Early and Late Parkinson's Disease Patients - an fMRI Study
A study testing Noninvasive transcutaneous auricular vagus nerve stimulation at 100Hz and Noninvasive transcutaneous auricular vagus nerve stimulation at 25Hz in people with Parkinson Disease and Neurologic Disorder, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
This is a randomised, within-subject, double-blinded, placebo-controlled study to assess the fMRI correlates of central nervous system (CNS) response to taVNS in early vs late-stage Parkinsons disease (PD), at two different frequencies. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Parkinson Disease, Neurologic Disorder
- What is being tested?
- Noninvasive transcutaneous auricular vagus nerve stimulation at 100Hz and Noninvasive transcutaneous auricular vagus nerve stimulation at 25Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Feb 2023to 29 Sep 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Parkinson's disease according to the UK PD Society Brain Bank criteria
- ability to walk independently for at least 2 minutes
- cognitive impairment that might prevent cooperation during tests
- stable antiparkinsonian medications during the previous 1 month
Who cannot join
- medication resistant rest tremor or dyskinesias
- history of seizures
- implanted medical devices or metal implants
- pregnancy
- claustrophobia
- fixed or severe kyphosis
- any conditions that would prevent our patients from lying still for 1 hour in a supine position (i.e. muscle pain, degenerative joint diseases…).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Auricular Vagl Nerve Electrostimulation of Brainstem Structures in Early and Late Parkinson's Disease Patients - an fMRI Study
This is a randomised, within-subject, double-blinded, placebo-controlled study to assess the fMRI correlates of central nervous system (CNS) response to taVNS in early vs late-stage Parkinsons disease (PD), at two different frequencies. Forty PD patients will be included: twenty patients with early-stage (Hoehn and Yahr stage (HY) 1-2) and twenty patients with late-stage (HY 3-4) PD. Each patient will undergo one stimulation session, where they will receive active taVNS at 100 Hz (taVNS100), taVNS at 25Hz (taVNS25) or will have positioned electrodes without stimulation (xVNS). The order of taVNS100, taVNS25 and xVNS will be randomized between subjects. The session will include (1) xVNS and taVNS; (2) MRI and fMRI and (3) heart rate and breathing rate monitoring. Clinical assessment with the Movement Disorder Society-Unified Parkinson's Disease Rating Scale will be done before the session.
Read the detailed description
Each participant will complete 1 visit, where the investigators will first assess the MDS-UPDRS score, afther that the sesnsitivity threasholds for taVNS at 25Hz and taVNS at 100Hz will be assessed. The Nemos® electrode for taVNS will be positioned in the left cymba conchae with the following parameters: square-shaped pseudobiphasic pulse, interpulse duration 80μs, pulse width 300μs. taVNS25 will be applied at 25Hz and taVNS100 will be applied at 100Hz. The sensory threshold will be assessed for each frequency and in the MRI scanner a pulse intensity of 0,1mA above the perceptual threshold will be applied.
After that the participant will be escorted to the MRI scanner where the MRI-safe electrode will be positioned in the left cymba conchae. The participant will be instructed to hold their head still during the complete experiment and that they will receive 3 different electrical stimulation types during 3 separate sessions. They will be further instructed that a black dot that will appear on the screen before each stimulation session and that they should fix their gaze on the dot. The instructions will be repeated before each BOLD MRI session.
MRI will be performed at the Center for Clinical physiology at the Medical faculty in Ljubljana (Center za klinično fiziologijo; CKF), using a 3T Philips Achieva 3TX dStream (Best, The Netherlands).
The investigators will acquire high-resolution T1-weighted and T2-weighted (0.7 x 0.7 x 0.7 mm^3) volumes of the brain. The area of brainstem and cerebellum will be scanned using a T1-weighted spectral pre-saturation with inversion recovery (SPIR) sequence to enhance the contrast of neuromelanin structures (and better delineate LC). The three structural scans will be interspaced with 3 time slots, containing three 8 minutes long block design blood oxygen level-dependent (BOLD MRI; fMRI) sessions (~1.75mm^3 isometric voxel). During each fMRI slot participants will receive a different type of stimulation (taVNS,25, taVNS100 and xVNS). While the participant will receive electrical stimulation during taVNS25 and taVNS100, there will be no current applied during xVNS. To reduce any carryover effect the investigators will randomise the order of the 3 fMRI sessions. The order of stimulation will not be revealed until the automated data and statistical analysis.
The timeline of the complete imaging session would be as follows: Survey scan - Slot 1 - T1 - Slot 2 - T2 - Slot 3 - neuromelanin sequence. The session should last up to 60 min. During this time the investigators will monitor heart rate and breathing rate remotely.
For the analysis T1-weighted images will be first segmented into grey, white and cerebrospinal fluid (CSF) tissue compartments using DARTEL, implemented in SPM12. This also provides spatial normalization and co-registration to the standard MNI space. Images from other modalities will first be co-registered to T1-weighted structural scans and next to the MNI template as secondary images using the identical transform algorithm. From the fMRI data the investigators will analyse (i) brainstem activation patterns (ROI analysis); and (ii) block design connectivity between nucleus tractus solitarii and central nervous system (CNS) structures and locus coeruleus and CNS stuctures. fMRI analyses will be done with Analysis of Functional NeuroImages (AFNI) tools.
- Conditions
- Parkinson Disease, Neurologic Disorder
- Being tested
- Noninvasive transcutaneous auricular vagus nerve stimulation at 100Hz, Noninvasive transcutaneous auricular vagus nerve stimulation at 25Hz, Sham cyma conchae stimulation
- Keywords
- Parkinson disease, taVNS, transcutaneous auricular vagal nerve stimulation, fMRI, brainstem ROI analysis
- Medical subject headings
- Parkinson Disease, Nervous System Diseases
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.
Sham cyma conchae stimulationDevice
Also called xVNS
The electrode will be placed at the cymba conchae location, however no electrical current will be applied. All other experimental conditions will be the same as for the active taVNS stimulation.
| Study group | Role | What they receive |
|---|---|---|
| taVNS100 in advanced PD patients | Active comparator | Noninvasive electrostimulation will be applied to the left cyma conchae through the Nemos® electrode at 100Hz to advanced PD patients. Participants will complete an 8 minute block design fMRI block. Receives: Device: Noninvasive transcutaneous auricular vagus nerve stimulation at 100Hz |
| taVNS25 in advanced PD patients | Active comparator | Noninvasive electrostimulation will be applied to the left cyma conchae through the Nemos® electrode at 25Hz to advanced PD patients. Participants will complete an 8 minute block design fMRI block. Receives: Device: Noninvasive transcutaneous auricular vagus nerve stimulation at 25Hz |
| xVNS in advanced PD patients | Placebo comparator | The electrode will be placed in the left cyma conchae however no electrical current will be applied to advanced PD patients. Participants will complete an 8 minute block design fMRI block. Receives: Device: Sham cyma conchae stimulation |
| taVNS100 in early PD patients | Active comparator | Noninvasive electrostimulation will be applied to the left cyma conchae through the Nemos® electrode at 100Hz to early PD patients. Participants will complete an 8 minute block design fMRI block. Receives: Device: Noninvasive transcutaneous auricular vagus nerve stimulation at 100Hz |
| taVNS25 in early PD patients | Active comparator | Noninvasive electrostimulation will be applied to the left cyma conchae through the Nemos® electrode at 25Hz to early PD patients. Participants will complete an 8 minute block design fMRI block. Receives: Device: Noninvasive transcutaneous auricular vagus nerve stimulation at 25Hz |
| xVNS in early PD patients | Placebo comparator | The electrode will be placed in the left cyma conchae however no electrical current will be applied to early PD patients. Participants will complete an 8 minute block design fMRI block. Receives: Device: Sham cyma conchae stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Brainstem activation pattern on fMRI (ROI analysis) during taVNS compared to xVNS
Block-design fMRI analysis will be performed on brainstem ROIs to assess activation in neuromodulatory brainstem nuclei during taVNS compared with xVNS using the tools of the AFNI program. Final analysis will be performed on group level.
Measured: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.
Comparison of Functional connectivity pattern on fMRI (block design) of nucleus tractus solitarii and the rest of the nervous system during taVNS compared to xVNS
Functional connectivity (fMRI, block design) between the nucleus tractus solitarii (NTS) and the rest of the central nervous system will be analysed with AFNI Context-Dependent Correlation Analysis to determine whether taVNS produces a different pattern of connectivity compared with xVNS.
Measured: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.
Comparison of Functional connectivity pattern on fMRI (block design) of locus coeruleus (LC) and the rest of the nervous system during taVNS compared to xVNS
Functional connectivity pattern (fMRI, block design) between the nucleus locus coeruleus (LC) and the rest of the central nervous system will be analysed with AFNI Context-Dependent Correlation Analysis to determine whether taVNS produces a different pattern of connectivity compared with xVNS.
Measured: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.
Secondary outcomes (3)
Comparison of Brainstem activation pattern on fMRI (ROI analysis) during taVNS25 compared to taVNS100
Block-design fMRI analysis will be performed on brainstem ROIs to assess activation in neuromodulatory brainstem nuclei during taVNS100 compared with taVNS25 using the tools of the AFNI program. Final analysis will be performed on group level.
Measured: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.
Comparison of Functional connectivity pattern on fMRI (block design) of nucleus tractus solitarii and the rest of the nervous system during taVNS25 compared to taVNS100
Functional connectivity (fMRI, block design) between the nucleus tractus solitarii (NTS) and the rest of the central nervous system will be analysed with AFNI Context-Dependent Correlation Analysis to determine whether taVNS produces a different pattern of connectivity compared with xVNS.
Measured: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.
Comparison of Functional connectivity pattern on fMRI (block design) of locus coeruleus (LC) and the rest of the nervous system during taVNS100 compared to taVNS25
Functional connectivity pattern (fMRI, block design) between the nucleus locus coeruleus (LC) and the rest of the central nervous system will be analysed with AFNI Context-Dependent Correlation Analysis to determine whether taVNS100 produces a different pattern of connectivity compared with taVNS25.
Measured: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start15 Feb 2023
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 40 participants with the diagnosis of PD patients aged \> 45 years will be included. Patients will be recruited from the outpatient and inpatient clinics. PD will be diagnosed according to the UK PD Society Brain Bank criteria: the investigators aim to include 20 patients with early-stage and 20 patients with late-stage PD. Each participant will complete 1 visit at the MRI scanning facility, during which they will complete 3 blocks of 8min block design fMRI. During each block they will receive a different kind of stimulation (taVNS25, taVNS100, xVNS; see detailed description). The effect will be compared within each group (early and advanced patients) and between groups (early vs advanced PD patients).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Responsible party
- Principal investigator, Andrej Vovk, University of Ljubljana
- Investigators
- Andrej Vovk, PhD, Principal investigator, Medical Faculty, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967598
- Sponsor's protocol ID
- 012052/2020-2
- Status last verified
- Oct 2023
- First submitted
- 5 Apr 2023
- 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.
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 Vagl Nerve Electrostimulation of Brainstem Structures in Early and Late Parkinson's Disease Patients - an fMRI Study
- ClinicalTrials.gov ID
- NCT05967598
- Acronym / sponsor ID
- 012052/2020-2
- Conditions
- Parkinson Disease, Neurologic Disorder
- Keywords
- Parkinson disease, taVNS, transcutaneous auricular vagal nerve stimulation, fMRI, brainstem ROI analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 1 Aug 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.
This is a randomised, within-subject, double-blinded, placebo-controlled study to assess the fMRI correlates of central nervous system (CNS) response to taVNS in early vs late-stage Parkinsons disease (PD), at two different frequencies. Forty PD patients will be included: twenty patients with early-stage (Hoehn and Yahr stage (HY) 1-2) and twenty patients with late-stage (HY 3-4) PD. Each patient will undergo one stimulation session, where they will receive active taVNS at 100 Hz (taVNS100), taVNS at 25Hz (taVNS25) or will have positioned electrodes without stimulation (xVNS). The order of taVNS100, taVNS25 and xVNS will be randomized between subjects. The session will include (1) xVNS and taVNS; (2) MRI and fMRI and (3) heart rate and breathing rate monitoring. Clinical assessment with the Movement Disorder Society-Unified Parkinson's Disease Rating Scale will be done before the session.
Detailed description
Each participant will complete 1 visit, where the investigators will first assess the MDS-UPDRS score, afther that the sesnsitivity threasholds for taVNS at 25Hz and taVNS at 100Hz will be assessed. The Nemos® electrode for taVNS will be positioned in the left cymba conchae with the following parameters: square-shaped pseudobiphasic pulse, interpulse duration 80μs, pulse width 300μs. taVNS25 will be applied at 25Hz and taVNS100 will be applied at 100Hz. The sensory threshold will be assessed for each frequency and in the MRI scanner a pulse intensity of 0,1mA above the perceptual threshold will be applied.
After that the participant will be escorted to the MRI scanner where the MRI-safe electrode will be positioned in the left cymba conchae. The participant will be instructed to hold their head still during the complete experiment and that they will receive 3 different electrical stimulation types during 3 separate sessions. They will be further instructed that a black dot that will appear on the screen before each stimulation session and that they should fix their gaze on the dot. The instructions will be repeated before each BOLD MRI session.
MRI will be performed at the Center for Clinical physiology at the Medical faculty in Ljubljana (Center za klinično fiziologijo; CKF), using a 3T Philips Achieva 3TX dStream (Best, The Netherlands).
The investigators will acquire high-resolution T1-weighted and T2-weighted (0.7 x 0.7 x 0.7 mm^3) volumes of the brain. The area of brainstem and cerebellum will be scanned using a T1-weighted spectral pre-saturation with inversion recovery (SPIR) sequence to enhance the contrast of neuromelanin structures (and better delineate LC). The three structural scans will be interspaced with 3 time slots, containing three 8 minutes long block design blood oxygen level-dependent (BOLD MRI; fMRI) sessions (~1.75mm^3 isometric voxel). During each fMRI slot participants will receive a different type of stimulation (taVNS,25, taVNS100 and xVNS). While the participant will receive electrical stimulation during taVNS25 and taVNS100, there will be no current applied during xVNS. To reduce any carryover effect the investigators will randomise the order of the 3 fMRI sessions. The order of stimulation will not be revealed until the automated data and statistical analysis.
The timeline of the complete imaging session would be as follows: Survey scan - Slot 1 - T1 - Slot 2 - T2 - Slot 3 - neuromelanin sequence. The session should last up to 60 min. During this time the investigators will monitor heart rate and breathing rate remotely.
For the analysis T1-weighted images will be first segmented into grey, white and cerebrospinal fluid (CSF) tissue compartments using DARTEL, implemented in SPM12. This also provides spatial normalization and co-registration to the standard MNI space. Images from other modalities will first be co-registered to T1-weighted structural scans and next to the MNI template as secondary images using the identical transform algorithm. From the fMRI data the investigators will analyse (i) brainstem activation patterns (ROI analysis); and (ii) block design connectivity between nucleus tractus solitarii and central nervous system (CNS) structures and locus coeruleus and CNS stuctures. fMRI analyses will be done with Analysis of Functional NeuroImages (AFNI) tools.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- 40 participants with the diagnosis of PD patients aged > 45 years will be included. Patients will be recruited from the outpatient and inpatient clinics. PD will be diagnosed according to the UK PD Society Brain Bank criteria: the investigators aim to include 20 patients with early-stage and 20 patients with late-stage PD. Each participant will complete 1 visit at the MRI scanning facility, during which they will complete 3 blocks of 8min block design fMRI. During each block they will receive a different kind of stimulation (taVNS25, taVNS100, xVNS; see detailed description). The effect will be compared within each group (early and advanced patients) and between groups (early vs advanced PD patients).
| Arm | Type | Receives |
|---|---|---|
| taVNS100 in advanced PD patients | 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 to advanced PD patients. Participants will complete an 8 minute block design fMRI block. |
| taVNS25 in advanced PD patients | 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 to advanced PD patients. Participants will complete an 8 minute block design fMRI block. |
| xVNS in advanced PD patients | Placebo comparator | Device: Sham cyma conchae stimulationThe electrode will be placed in the left cyma conchae however no electrical current will be applied to advanced PD patients. Participants will complete an 8 minute block design fMRI block. |
| taVNS100 in early PD patients | 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 to early PD patients. Participants will complete an 8 minute block design fMRI block. |
| taVNS25 in early PD patients | 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 to early PD patients. Participants will complete an 8 minute block design fMRI block. |
| xVNS in early PD patients | Placebo comparator | Device: Sham cyma conchae stimulationThe electrode will be placed in the left cyma conchae however no electrical current will be applied to early PD patients. Participants will complete an 8 minute block design fMRI block. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of Parkinson's disease according to the UK PD Society Brain Bank criteria
- ability to walk independently for at least 2 minutes
- cognitive impairment that might prevent cooperation during tests
- stable antiparkinsonian medications during the previous 1 month
Key exclusion criteria (7 listed)
- medication resistant rest tremor or dyskinesias
- history of seizures
- implanted medical devices or metal implants
- pregnancy
- claustrophobia
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 in advanced PD patients, taVNS100 in early PD patients |
| 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 in advanced PD patients, taVNS25 in early PD patients |
| Sham cyma conchae stimulationAlso: xVNSThe electrode will be placed at the cymba conchae location, however no electrical current will be applied. All other experimental conditions will be the same as for the active taVNS stimulation. | Device | xVNS in advanced PD patients, xVNS in early PD patients |
Primary outcome
Comparison of Brainstem activation pattern on fMRI (ROI analysis) during taVNS compared to xVNS
Time frame: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.
Block-design fMRI analysis will be performed on brainstem ROIs to assess activation in neuromodulatory brainstem nuclei during taVNS compared with xVNS using the tools of the AFNI program. Final analysis will be performed on group level.
Comparison of Functional connectivity pattern on fMRI (block design) of nucleus tractus solitarii and the rest of the nervous system during taVNS compared to xVNS
Time frame: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.
Functional connectivity (fMRI, block design) between the nucleus tractus solitarii (NTS) and the rest of the central nervous system will be analysed with AFNI Context-Dependent Correlation Analysis to determine whether taVNS produces a different pattern of connectivity compared with xVNS.
Comparison of Functional connectivity pattern on fMRI (block design) of locus coeruleus (LC) and the rest of the nervous system during taVNS compared to xVNS
Time frame: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.
Functional connectivity pattern (fMRI, block design) between the nucleus locus coeruleus (LC) and the rest of the central nervous system will be analysed with AFNI Context-Dependent Correlation Analysis to determine whether taVNS produces a different pattern of connectivity compared with xVNS.
3 secondary outcomes
Comparison of Brainstem activation pattern on fMRI (ROI analysis) during taVNS25 compared to taVNS100
Time frame: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.
Comparison of Functional connectivity pattern on fMRI (block design) of nucleus tractus solitarii and the rest of the nervous system during taVNS25 compared to taVNS100
Time frame: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.
Comparison of Functional connectivity pattern on fMRI (block design) of locus coeruleus (LC) and the rest of the nervous system during taVNS100 compared to taVNS25
Time frame: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.
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.
- 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.
Andrej Vovk, PhD principal investigator
Medical Faculty, University of 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 and Noninvasive transcutaneous auricular vagus nerve stimulation at 25Hz in people with Parkinson Disease and Neurologic Disorder, run by University of 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 4 inclusion and 7 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?
Comparison of Brainstem activation pattern on fMRI (ROI analysis) during taVNS compared to xVNS (time frame: Only the online/acute effect measured during stimulation (time frame duration of 8 minutes per stimulation type) will be analysed.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.