HealthySMTaVNS2024NCT06294509
TaVNS Application Timing During Robotic Sensorimotor Task
A study testing in-house developed transcutaneous auricular Vagus Nerve Stimulation device in people with Healthy, run by Olivier Lambercy at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to evaluate the feasibility and effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in enhancing sensorimotor learning and adaptation. This study will focus on healthy individuals performing a robotic sensorimotor task. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- in-house developed transcutaneous auricular Vagus Nerve Stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 May 2024to 1 Apr 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants above 18 years of age and able to provide informed consent and understand the study requirements
Who cannot join
- Individuals with major untreated depression, major cognitive and/or communication deficits, and major comprehension and/or memory deficits that may interfere with the informed consent process, task-specific practice, or communication of adverse events will be excluded from the study.
- Neurological conditions such as epilepsy, participation in any other research trial, pregnancy, use of implanted electrical devices, and use of medication or procedure that interferes with vagal functions.
- Pregnancy or trying to get pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Effects of Transcutaneous Auricular Vagus Nerve Stimulation Timings in a Sensorimotor Task
The goal of this clinical trial is to evaluate the feasibility and effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in enhancing sensorimotor learning and adaptation. This study will focus on healthy individuals performing a robotic sensorimotor task.
Main Questions it Aims to Answer:
Read more
How does taVNS, with different timing protocols, affect the feasibility and effectiveness of performing a robotic sensorimotor task? What is the impact of taVNS on sensorimotor learning and adaptation?
Participants Will:
Be pseudo-randomly assigned to one of five experimental groups with different taVNS stimulation timings.
Perform a sensorimotor task multiple times across sessions, spanning a maximum of two weeks or until achieving 70% accuracy in two successive sessions.
Have kinematic data collected by a robot during the task. Have physiological data measured using external sensors. Fill out questionnaires about the feasibility of taVNS and other subjective measures after each session.
Comparison Group:
Researchers will compare the four experimental groups to each other to see if different taVNS stimulation timings affect sensorimotor learning outcomes, as well as to a control group that will receive no stimulation.
Read the detailed description
Overview:
This study focuses on the potential of transcutaneous auricular Vagus Nerve Stimulation (taVNS) in motor neurorehabilitation for conditions like Parkinson's disease, traumatic brain injury, spinal cord injury, and stroke. taVNS, approved for various neurological conditions and known for its safety, activates neuromodulators contributing to plasticity and motor learning. However, the optimal stimulation parameters, especially timing during movement, are not fully explored.
Study Goals:
Primary Objective: To assess the feasibility and effects of different taVNS timing protocols in a robotic sensorimotor task on sensorimotor learning and adaptation. The hypothesis is that varying taVNS-movement timings will influence both subjective and objective feasibility measures and sensorimotor adaptation.
Secondary Objectives: To compare movement kinematics and contrast perceived stimulation effects with measured physiological outcomes and task performance metrics.
Methodology:
The study will be conducted at Swiss Federal Institute of Technology (ETH) Zurich with healthy subjects using a robotic sensorimotor task to evaluate the feasibility of movement-timed taVNS and its influence on learning new sensorimotor skills.
Participants will be assigned different stimulation timings, with the study assessing motor learning and performance consistency across a maximum of 6 sessions or until 70% success is reached in two successive sessions.
The study design is single-blinded, pseudo-randomized, exploratory, and longitudinal, employing controls like no stimulation and randomly-timed stimulation.
Intervention Details:
Before each session, two electrodes (e.g. TensCare pads) will be connected to the pulse generator and 1) placed on the cymbae conchae of the ear and 2) on the tragus of the ear, allowing for a previously described taVNS biphasic pulse train to travel. Here, biphasic square pulses of 250ms width are sent at 25 Hertz (Hz) frequency for 0.5s at a maximum aptitude of 3 milliamperes (mA). The stimulation pulses are current-controlled, limited to 50 Volts (V) and regulated by a pulse generator that limits deliverable current in hardware by design with serial resistors and diodes.
At the start of the session, participants will use a python graphical user interface (GUI) to calibrate the desired taVNS amplitude by gradually increasing it from minimal 0.1 mA up to the maximal tolerated amplitude below 3 mA in the intervals of 0.1 mA. The level of intensity will be set to 90% of the maximally tolerated amplitude for the person (typical ~1.5-2 mA \& limited to 3mA, which is significantly below the safety limit of 50mA (according to the Product Safety Standards for Medical Devices, IEC 60601-2-10:2012). This procedure takes 1-2 min. Following the calibration, the session with the sensorimotor task will begin.
Sensorimotor task The sensorimotor task utilizes a commercial haptic end effector (Touch, 3D systems), a custom made 3D printed handle and a virtual reality environment, implemented in python and PsychoPy software on a Microsoft Windows laptop. The robotic manipulandum is synchronized to a 1cm circular cursor in the workspace of the virtual environment. Additionally, an arm-support (SaeboMas Mini) is used to support the arm against gravity to reduce fatigue and keep the arm in the correct position - elbow is 90 degrees perpendicular to the ground.
The goal of the sensorimotor task is to reach a 2.4cm target at a distance of 10 cm away from a starting position, both visually represented in the virtual environment. In order to successfully complete a trial the participant must reach the target within a time constraint of 0.5 s +/- 0.067 s. There will be a 0.5 s tone sound notifying the target duration of the movement. During this movement the cursor position is hidden and not displayed on the screen (in perturbation and retention phases) in order to force feedforward motor adaptation, rather than visually-guided feedback control, as feedforward adaptation may be impaired in stroke patients. Results of each trial are displayed as 3 distinct possibilities - correct, target reached too quickly, or target not reached. The subject will be notified of the outcome of the trial by the target turning either, green, orange or red respectively. Afterwards the start location will be displayed for the participant to return to. After 1-3 s within the starting point a new trial will be initiated.
Participants will perform 75 baseline trials (no visuomotor rotation) to get familiar with the robotic manipulandum and the environment. Then participants will perform an additional 150 trials in the challenged condition with a virtual rotational field (visuomotor rotation/perturbation), displayed on the screen. Subjects will not be informed about the nature of the sensorimotor challenge and will have to progressively learn the corrective mapping to adapt to the perturbation. No external forces will be applied and the haptic end-effector is solely used to measure handle end-point kinematics. Then subjects will perform 50 trials of the same baseline trials (wash-out) and finally 50 more trials of the rotational field (retention). The time requirement is expected to be 5-10 min for the setup and explanations and ~30 min for the sensorimotor task. Data from each trial will be stored containing the position of the cursor, success/fail and time information for subsequent analysis. Additional movement kinematic data may be collected using inertial measurement unit (IMU) sensors worn on the wrist. The IMU records acceleration and gyroscope measurements and logs data to the experimental computer at a rate of 120Hz. Additionally all data pertaining to stimulation will be stored, this includes timing, impedance measurements and all communication commands to and from the stimulator.
Research Significance:
The findings could inform future clinical studies in neurorehabilitation. The study uses a "Touch™" haptic device for the task, ensuring participant safety and comfort.
Potential side effects of taVNS are minimal and closely monitored.
- Conditions
- Healthy
- Being tested
- in-house developed transcutaneous auricular Vagus Nerve Stimulation device
- Keywords
- sensorimotor adaptation, motor learning, transcutaneous auricular Vagus nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-house developed transcutaneous auricular Vagus Nerve Stimulation deviceDevice
taVNS in this study involves short electric pulses (0.25 ms) delivered to the ear's skin to activate the auricular branch of the Vagus. The pulses are current-controlled to ensure stability and delivered in a bipolar fashion to prevent skin irritation. Before each session, taVNS is calibrated for each participant. Starting at 0.1 mA, the intensity is increased stepwise until a comfortable maximum (typically 1.5-2.5 mA) is reached. Stimuli are delivered in short trains lasting 0.5 seconds each, with 13 pulses (0.25ms each) per train. Participants receive a maximum of 150 stimuli per session, totaling a maximum of 75 seconds of cumulative stimulation. Participants adapt their movements over up to six sessions across two weeks. The robotic task facilitates accurate movement tracking and provides interactive real-time feedback.
| Study group | Role | What they receive |
|---|---|---|
| No stimulation (control) | No intervention | Participants will wear device but will not receive any stimulation |
| Movement-unrelated stimulation (control) | Active comparator | Participants will wear device and receive randomly timed stimulation Receives: Device: in-house developed transcutaneous auricular Vagus Nerve Stimulation device |
| pre-movement taVNS | Experimental | Stimulation will start after 500ms of being in the home position, before the onset of the movement cue. Receives: Device: in-house developed transcutaneous auricular Vagus Nerve Stimulation device |
| during-movement taVNS | Experimental | Stimulation will occur during the movement phase. Receives: Device: in-house developed transcutaneous auricular Vagus Nerve Stimulation device |
| post-movement taVNS | Experimental | Stimulation will occur immediately after a successful trial (no stimulation if the trial is failed). Receives: Device: in-house developed transcutaneous auricular Vagus Nerve Stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjectively perceived tolerance of taVNS and perceived difficulty of motor task
The subjective perceived feasibility of the taVNS stimulation paradigm, perceived difficulty level of the task, assessed by an unvalidated questionnaire on the Likert scale.
Measured: From enrollment to end of study at 2 weeks
Success of the sensorimotor challenge
Measured as % of trials where the end-point reaching target (2.4 cm diameter) was reached within an allocated time period (0.5 s +/- 0.067 s).
Measured: After the intervention
Mean Change from Baseline in Galvanic Skin Response (GSR)
Physiological dose response to the taVNS using GSR as indicator
Measured: During and immediately after taVNS
Mean Change from Baseline in Heart Rate (HR)
Physiological dose response to the taVNS using HR as indicator
Measured: During and immediately after taVNS
Mean Change from Baseline in Pupil Diameter (PD)
Physiological dose response to the taVNS using PD as indicator
Measured: During and immediately after taVNS
Mean Change from Baseline in electroencephalogram (EEG)
Physiological dose response to the taVNS using EEG as indicator
Measured: During and immediately after taVNS
Secondary outcomes (3)
Subjectively perceived positive effects of taVNS on motor performance
Subjectively perceived success during taVNS and perceived effects of the taVNS stimulation during the task, assessed by an unvalidated questionnaire on the Likert scale.
Measured: After each session, from enrollment to end of treatment at 2 weeks
Change of movement parameters from baseline
Movement kinematics, as recorded by robotic sensors, will be analyzed to assess quantitative properties of the movements. For example, mean velocity, smoothness of acceleration and trajectory
Measured: After each session, from enrollment to end of study at 2 weeks
Associations between outcomes
Association between subjective and objective feasibility measures will be analyzed using multiple way ANOVA tests for each of the measures
Measured: upon completion of study, at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start14 May 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Parallel groups
- Model description
- Single-blinded, pseudo-randomised, exploratory, single-centre, national, longitudinal study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivier Lambercy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olivier Lambercy, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294509
- Sponsor's protocol ID
- SMTaVNS 2024
- Other IDs
- 2024-00039
- Acronym
- SMTaVNS2024
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned
Publications
Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1.
PubMed 36543841Baig SS, Kamarova M, Bell SM, Ali AN, Su L, Dimairo M, Dawson J, Redgrave JN, Majid A. tVNS in Stroke: A Narrative Review on the Current State and the Future. Stroke. 2023 Oct;54(10):2676-2687. doi: 10.1161/STROKEAHA.123.043414. Epub 2023 Aug 30.
PubMed 37646161Badran BW, Peng X, Baker-Vogel B, Hutchison S, Finetto P, Rishe K, Fortune A, Kitchens E, O'Leary GH, Short A, Finetto C, Woodbury ML, Kautz S. Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2023 Jun;37(6):374-383. doi: 10.1177/15459683231173357. Epub 2023 May 20.
PubMed 37209010Branscheidt M, Hadjiosif AM, Anaya MA, Keller J, Widmer M, Runnalls KD, Luft AR, Bastian AJ, Krakauer JW, Celnik PA. Reinforcement Learning Is Impaired in the Sub-acute Post-stroke Period. bioRxiv [Preprint]. 2023 Jan 25:2023.01.25.525408. doi: 10.1101/2023.01.25.525408.
PubMed 36747674Dietrich S, Smith J, Scherzinger C, Hofmann-Preiss K, Freitag T, Eisenkolb A, Ringler R. A novel transcutaneous vagus nerve stimulation leads to brainstem and cerebral activations measured by functional MRI. Biomed Tech (Berl). 2008 Jun;53(3):104-11. doi: 10.1515/BMT.2008.022.
PubMed 18601618Breton-Provencher V, Drummond GT, Sur M. Locus Coeruleus Norepinephrine in Learned Behavior: Anatomical Modularity and Spatiotemporal Integration in Targets. Front Neural Circuits. 2021 Jun 7;15:638007. doi: 10.3389/fncir.2021.638007. eCollection 2021.
PubMed 34163331Gielow MR, Zaborszky L. The Input-Output Relationship of the Cholinergic Basal Forebrain. Cell Rep. 2017 Feb 14;18(7):1817-1830. doi: 10.1016/j.celrep.2017.01.060.
PubMed 28199851Izawa J, Shadmehr R. Learning from sensory and reward prediction errors during motor adaptation. PLoS Comput Biol. 2011 Mar;7(3):e1002012. doi: 10.1371/journal.pcbi.1002012. Epub 2011 Mar 10.
PubMed 21423711Morrison RA, Hulsey DR, Adcock KS, Rennaker RL 2nd, Kilgard MP, Hays SA. Vagus nerve stimulation intensity influences motor cortex plasticity. Brain Stimul. 2019 Mar-Apr;12(2):256-262. doi: 10.1016/j.brs.2018.10.017. Epub 2018 Nov 3.
PubMed 30409712Rodenkirch C, Carmel JB, Wang Q. Rapid Effects of Vagus Nerve Stimulation on Sensory Processing Through Activation of Neuromodulatory Systems. Front Neurosci. 2022 Jul 5;16:922424. doi: 10.3389/fnins.2022.922424. eCollection 2022.
PubMed 35864985Bowles S, Hickman J, Peng X, Williamson WR, Huang R, Washington K, Donegan D, Welle CG. Vagus nerve stimulation drives selective circuit modulation through cholinergic reinforcement. Neuron. 2022 Sep 7;110(17):2867-2885.e7. doi: 10.1016/j.neuron.2022.06.017. Epub 2022 Jul 19.
PubMed 35858623Donegan D, Kanzler CM, Buscher J, Viskaitis P, Bracey EF, Lambercy O, Burdakov D. Hypothalamic Control of Forelimb Motor Adaptation. J Neurosci. 2022 Aug 10;42(32):6243-6257. doi: 10.1523/JNEUROSCI.0705-22.2022. Epub 2022 Jul 5.
PubMed 35790405Wickens JR, Reynolds JN, Hyland BI. Neural mechanisms of reward-related motor learning. Curr Opin Neurobiol. 2003 Dec;13(6):685-90. doi: 10.1016/j.conb.2003.10.013.
PubMed 14662369Donegan D, Peleg-Raibstein D, Lambercy O, Burdakov D. Anticipatory countering of motor challenges by premovement activation of orexin neurons. PNAS Nexus. 2022 Oct 25;1(5):pgac240. doi: 10.1093/pnasnexus/pgac240. eCollection 2022 Nov.
PubMed 36712356Kanzler CM, Averta G, Schwarz A, Held JPO, Gassert R, Bicchi A, Santello M, Lambercy O, Bianchi M. A low-dimensional representation of arm movements and hand grip forces in post-stroke individuals. Sci Rep. 2022 May 9;12(1):7601. doi: 10.1038/s41598-022-11806-4.
PubMed 35534629
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effects of Transcutaneous Auricular Vagus Nerve Stimulation Timings in a Sensorimotor Task
- ClinicalTrials.gov ID
- NCT06294509
- Acronym / sponsor ID
- SMTaVNS2024 / SMTaVNS 2024
- Conditions
- Healthy
- Keywords
- sensorimotor adaptation, motor learning, transcutaneous auricular Vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Olivier LambercyUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 5 Mar 2024 (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.
The goal of this clinical trial is to evaluate the feasibility and effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in enhancing sensorimotor learning and adaptation. This study will focus on healthy individuals performing a robotic sensorimotor task.
Main Questions it Aims to Answer:
How does taVNS, with different timing protocols, affect the feasibility and effectiveness of performing a robotic sensorimotor task? What is the impact of taVNS on sensorimotor learning and adaptation?
Participants Will:
Be pseudo-randomly assigned to one of five experimental groups with different taVNS stimulation timings.
Perform a sensorimotor task multiple times across sessions, spanning a maximum of two weeks or until achieving 70% accuracy in two successive sessions.
Have kinematic data collected by a robot during the task. Have physiological data measured using external sensors. Fill out questionnaires about the feasibility of taVNS and other subjective measures after each session.
Comparison Group:
Researchers will compare the four experimental groups to each other to see if different taVNS stimulation timings affect sensorimotor learning outcomes, as well as to a control group that will receive no stimulation.
Detailed description
Overview:
This study focuses on the potential of transcutaneous auricular Vagus Nerve Stimulation (taVNS) in motor neurorehabilitation for conditions like Parkinson's disease, traumatic brain injury, spinal cord injury, and stroke. taVNS, approved for various neurological conditions and known for its safety, activates neuromodulators contributing to plasticity and motor learning. However, the optimal stimulation parameters, especially timing during movement, are not fully explored.
Study Goals:
Primary Objective: To assess the feasibility and effects of different taVNS timing protocols in a robotic sensorimotor task on sensorimotor learning and adaptation. The hypothesis is that varying taVNS-movement timings will influence both subjective and objective feasibility measures and sensorimotor adaptation.
Secondary Objectives: To compare movement kinematics and contrast perceived stimulation effects with measured physiological outcomes and task performance metrics.
Methodology:
The study will be conducted at Swiss Federal Institute of Technology (ETH) Zurich with healthy subjects using a robotic sensorimotor task to evaluate the feasibility of movement-timed taVNS and its influence on learning new sensorimotor skills.
Participants will be assigned different stimulation timings, with the study assessing motor learning and performance consistency across a maximum of 6 sessions or until 70% success is reached in two successive sessions.
The study design is single-blinded, pseudo-randomized, exploratory, and longitudinal, employing controls like no stimulation and randomly-timed stimulation.
Intervention Details:
Before each session, two electrodes (e.g. TensCare pads) will be connected to the pulse generator and 1) placed on the cymbae conchae of the ear and 2) on the tragus of the ear, allowing for a previously described taVNS biphasic pulse train to travel. Here, biphasic square pulses of 250ms width are sent at 25 Hertz (Hz) frequency for 0.5s at a maximum aptitude of 3 milliamperes (mA). The stimulation pulses are current-controlled, limited to 50 Volts (V) and regulated by a pulse generator that limits deliverable current in hardware by design with serial resistors and diodes.
At the start of the session, participants will use a python graphical user interface (GUI) to calibrate the desired taVNS amplitude by gradually increasing it from minimal 0.1 mA up to the maximal tolerated amplitude below 3 mA in the intervals of 0.1 mA. The level of intensity will be set to 90% of the maximally tolerated amplitude for the person (typical ~1.5-2 mA \& limited to 3mA, which is significantly below the safety limit of 50mA (according to the Product Safety Standards for Medical Devices, IEC 60601-2-10:2012). This procedure takes 1-2 min. Following the calibration, the session with the sensorimotor task will begin.
Sensorimotor task The sensorimotor task utilizes a commercial haptic end effector (Touch, 3D systems), a custom made 3D printed handle and a virtual reality environment, implemented in python and PsychoPy software on a Microsoft Windows laptop. The robotic manipulandum is synchronized to a 1cm circular cursor in the workspace of the virtual environment. Additionally, an arm-support (SaeboMas Mini) is used to support the arm against gravity to reduce fatigue and keep the arm in the correct position - elbow is 90 degrees perpendicular to the ground.
The goal of the sensorimotor task is to reach a 2.4cm target at a distance of 10 cm away from a starting position, both visually represented in the virtual environment. In order to successfully complete a trial the participant must reach the target within a time constraint of 0.5 s +/- 0.067 s. There will be a 0.5 s tone sound notifying the target duration of the movement. During this movement the cursor position is hidden and not displayed on the screen (in perturbation and retention phases) in order to force feedforward motor adaptation, rather than visually-guided feedback control, as feedforward adaptation may be impaired in stroke patients. Results of each trial are displayed as 3 distinct possibilities - correct, target reached too quickly, or target not reached. The subject will be notified of the outcome of the trial by the target turning either, green, orange or red respectively. Afterwards the start location will be displayed for the participant to return to. After 1-3 s within the starting point a new trial will be initiated.
Participants will perform 75 baseline trials (no visuomotor rotation) to get familiar with the robotic manipulandum and the environment. Then participants will perform an additional 150 trials in the challenged condition with a virtual rotational field (visuomotor rotation/perturbation), displayed on the screen. Subjects will not be informed about the nature of the sensorimotor challenge and will have to progressively learn the corrective mapping to adapt to the perturbation. No external forces will be applied and the haptic end-effector is solely used to measure handle end-point kinematics. Then subjects will perform 50 trials of the same baseline trials (wash-out) and finally 50 more trials of the rotational field (retention). The time requirement is expected to be 5-10 min for the setup and explanations and ~30 min for the sensorimotor task. Data from each trial will be stored containing the position of the cursor, success/fail and time information for subsequent analysis. Additional movement kinematic data may be collected using inertial measurement unit (IMU) sensors worn on the wrist. The IMU records acceleration and gyroscope measurements and logs data to the experimental computer at a rate of 120Hz. Additionally all data pertaining to stimulation will be stored, this includes timing, impedance measurements and all communication commands to and from the stimulator.
Research Significance:
The findings could inform future clinical studies in neurorehabilitation. The study uses a "Touch™" haptic device for the task, ensuring participant safety and comfort.
Potential side effects of taVNS are minimal and closely monitored.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Single-blinded, pseudo-randomised, exploratory, single-centre, national, longitudinal study
| Arm | Type | Receives |
|---|---|---|
| No stimulation (control) | No intervention | –Participants will wear device but will not receive any stimulation |
| Movement-unrelated stimulation (control) | Active comparator | Device: in-house developed transcutaneous auricular Vagus Nerve Stimulation deviceParticipants will wear device and receive randomly timed stimulation |
| pre-movement taVNS | Experimental | Device: in-house developed transcutaneous auricular Vagus Nerve Stimulation deviceStimulation will start after 500ms of being in the home position, before the onset of the movement cue. |
| during-movement taVNS | Experimental | Device: in-house developed transcutaneous auricular Vagus Nerve Stimulation deviceStimulation will occur during the movement phase. |
| post-movement taVNS | Experimental | Device: in-house developed transcutaneous auricular Vagus Nerve Stimulation deviceStimulation will occur immediately after a successful trial (no stimulation if the trial is failed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy participants above 18 years of age and able to provide informed consent and understand the study requirements
Key exclusion criteria (3 listed)
- Individuals with major untreated depression, major cognitive and/or communication deficits, and major comprehension and/or memory deficits that may interfere with the informed consent process, task-specific practice, or communication of adverse events will be excluded from the study.
- Neurological conditions such as epilepsy, participation in any other research trial, pregnancy, use of implanted electrical devices, and use of medication or procedure that interferes with vagal functions.
- Pregnancy or trying to get pregnant.
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 |
|---|---|---|
| in-house developed transcutaneous auricular Vagus Nerve Stimulation devicetaVNS in this study involves short electric pulses (0.25 ms) delivered to the ear's skin to activate the auricular branch of the Vagus. The pulses are current-controlled to ensure stability and delivered in a bipolar fashion to prevent skin irritation. Before each session, taVNS is calibrated for each participant. Starting at 0.1 mA, the intensity is increased stepwise until a comfortable maximum (typically 1.5-2.5 mA) is reached. Stimuli are delivered in short trains lasting 0.5 seconds each, with 13 pulses (0.25ms each) per train. Participants receive a maximum of 150 stimuli per session, totaling a maximum of 75 seconds of cumulative stimulation. Participants adapt their movements over up to six sessions across two weeks. The robotic task facilitates accurate movement tracking and provides interactive real-time feedback. | Device | Movement-unrelated stimulation (control), during-movement taVNS, post-movement taVNS, pre-movement taVNS |
Primary outcome
Subjectively perceived tolerance of taVNS and perceived difficulty of motor task
Time frame: From enrollment to end of study at 2 weeks
The subjective perceived feasibility of the taVNS stimulation paradigm, perceived difficulty level of the task, assessed by an unvalidated questionnaire on the Likert scale.
Success of the sensorimotor challenge
Time frame: After the intervention
Measured as % of trials where the end-point reaching target (2.4 cm diameter) was reached within an allocated time period (0.5 s +/- 0.067 s).
Mean Change from Baseline in Galvanic Skin Response (GSR)
Time frame: During and immediately after taVNS
Physiological dose response to the taVNS using GSR as indicator
Mean Change from Baseline in Heart Rate (HR)
Time frame: During and immediately after taVNS
Physiological dose response to the taVNS using HR as indicator
Mean Change from Baseline in Pupil Diameter (PD)
Time frame: During and immediately after taVNS
Physiological dose response to the taVNS using PD as indicator
Mean Change from Baseline in electroencephalogram (EEG)
Time frame: During and immediately after taVNS
Physiological dose response to the taVNS using EEG as indicator
3 secondary outcomes
Subjectively perceived positive effects of taVNS on motor performance
Time frame: After each session, from enrollment to end of treatment at 2 weeks
Change of movement parameters from baseline
Time frame: After each session, from enrollment to end of study at 2 weeks
Associations between outcomes
Time frame: upon completion of study, at 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 36543841Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1.
- Background: PubMed 37646161Baig SS, Kamarova M, Bell SM, Ali AN, Su L, Dimairo M, Dawson J, Redgrave JN, Majid A. tVNS in Stroke: A Narrative Review on the Current State and the Future. Stroke. 2023 Oct;54(10):2676-2687. doi: 10.1161/STROKEAHA.123.043414. Epub 2023 Aug 30.
- Background: PubMed 37209010Badran BW, Peng X, Baker-Vogel B, Hutchison S, Finetto P, Rishe K, Fortune A, Kitchens E, O'Leary GH, Short A, Finetto C, Woodbury ML, Kautz S. Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2023 Jun;37(6):374-383. doi: 10.1177/15459683231173357. Epub 2023 May 20.
- Background: PubMed 36747674Branscheidt M, Hadjiosif AM, Anaya MA, Keller J, Widmer M, Runnalls KD, Luft AR, Bastian AJ, Krakauer JW, Celnik PA. Reinforcement Learning Is Impaired in the Sub-acute Post-stroke Period. bioRxiv [Preprint]. 2023 Jan 25:2023.01.25.525408. doi: 10.1101/2023.01.25.525408.
- Background: PubMed 18601618Dietrich S, Smith J, Scherzinger C, Hofmann-Preiss K, Freitag T, Eisenkolb A, Ringler R. A novel transcutaneous vagus nerve stimulation leads to brainstem and cerebral activations measured by functional MRI. Biomed Tech (Berl). 2008 Jun;53(3):104-11. doi: 10.1515/BMT.2008.022.
- Background: PubMed 34163331Breton-Provencher V, Drummond GT, Sur M. Locus Coeruleus Norepinephrine in Learned Behavior: Anatomical Modularity and Spatiotemporal Integration in Targets. Front Neural Circuits. 2021 Jun 7;15:638007. doi: 10.3389/fncir.2021.638007. eCollection 2021.
- Background: PubMed 28199851Gielow MR, Zaborszky L. The Input-Output Relationship of the Cholinergic Basal Forebrain. Cell Rep. 2017 Feb 14;18(7):1817-1830. doi: 10.1016/j.celrep.2017.01.060.
- Background: PubMed 21423711Izawa J, Shadmehr R. Learning from sensory and reward prediction errors during motor adaptation. PLoS Comput Biol. 2011 Mar;7(3):e1002012. doi: 10.1371/journal.pcbi.1002012. Epub 2011 Mar 10.
- Background: PubMed 30409712Morrison RA, Hulsey DR, Adcock KS, Rennaker RL 2nd, Kilgard MP, Hays SA. Vagus nerve stimulation intensity influences motor cortex plasticity. Brain Stimul. 2019 Mar-Apr;12(2):256-262. doi: 10.1016/j.brs.2018.10.017. Epub 2018 Nov 3.
- Background: PubMed 35864985Rodenkirch C, Carmel JB, Wang Q. Rapid Effects of Vagus Nerve Stimulation on Sensory Processing Through Activation of Neuromodulatory Systems. Front Neurosci. 2022 Jul 5;16:922424. doi: 10.3389/fnins.2022.922424. eCollection 2022.
- Background: PubMed 35858623Bowles S, Hickman J, Peng X, Williamson WR, Huang R, Washington K, Donegan D, Welle CG. Vagus nerve stimulation drives selective circuit modulation through cholinergic reinforcement. Neuron. 2022 Sep 7;110(17):2867-2885.e7. doi: 10.1016/j.neuron.2022.06.017. Epub 2022 Jul 19.
- Background: PubMed 35790405Donegan D, Kanzler CM, Buscher J, Viskaitis P, Bracey EF, Lambercy O, Burdakov D. Hypothalamic Control of Forelimb Motor Adaptation. J Neurosci. 2022 Aug 10;42(32):6243-6257. doi: 10.1523/JNEUROSCI.0705-22.2022. Epub 2022 Jul 5.
- Individual participant dataSharing planned: No. Not planned
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in-house developed transcutaneous auricular Vagus Nerve Stimulation device in people with Healthy, run by Olivier Lambercy at 1 site in Switzerland.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Oct 2024. 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 Switzerland. 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. 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?
Results are not available in the source record.
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?
Subjectively perceived tolerance of taVNS and perceived difficulty of motor task (time frame: From enrollment to end of study at 2 weeks). The study lists 6 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 NCT06294509, which also lists 24 linked publications.
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 29 Oct 2024.