Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294509
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-28
Brief Title:
taVNS Application Timing During Robotic Sensorimotor Task
Sponsor:
Olivier Lambercy
Organization:
Swiss Federal Institute of Technology
Study Overview
Official Title:
Feasibility and Effects of Transcutaneous Auricular Vagus Nerve Stimulation Timings in a Sensorimotor Task
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMTaVNS2024
Brief 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
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
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 Parkinsons 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 eg 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 05s 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 01 mA up to the maximal tolerated amplitude below 3 mA in the intervals of 01 mA The level of intensity will be set to 90 of the maximally tolerated amplitude for the person typical 15-2 mA limited to 3mA which is significantly below the safety limit of 50mA according to the Product Safety Standards for Medical Devices IEC 60601-2-102012 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 24cm 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 05 s - 0067 s There will be a 05 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 rotationperturbation 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 successfail 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
This study focuses on the potential of transcutaneous auricular Vagus Nerve Stimulation taVNS in motor neurorehabilitation for conditions like Parkinsons 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 eg 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 05s 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 01 mA up to the maximal tolerated amplitude below 3 mA in the intervals of 01 mA The level of intensity will be set to 90 of the maximally tolerated amplitude for the person typical 15-2 mA limited to 3mA which is significantly below the safety limit of 50mA according to the Product Safety Standards for Medical Devices IEC 60601-2-102012 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 24cm 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 05 s - 0067 s There will be a 05 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 rotationperturbation 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 successfail 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-00039 | REGISTRY | BASEC | None |