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TaVNS Application Timing During Robotic Sensorimotor Task

NCT06294509 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-10-29

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DEVICE

in-house developed transcutaneous auricular Vagus Nerve Stimulation device

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.

Sponsors & Collaborators

  • Olivier Lambercy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2025-01-01
Completion
2025-04-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06294509 on ClinicalTrials.gov