Feasibility and Effects of Transcutaneous Auricular Vagus Nerve Stimulation Timings in a Sensorimotor Task
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Success of the sensorimotor challenge
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants above 18 years of age and able to provide informed consent and understand the study requirements
排除标准
- •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.
研究组 & 干预措施
No stimulation (control)
Participants will wear device but will not receive any stimulation
Movement-unrelated stimulation (control)
Participants will wear device and receive randomly timed stimulation
干预措施: in-house developed transcutaneous auricular Vagus Nerve Stimulation device (Device)
pre-movement taVNS
Stimulation will start after 500ms of being in the home position, before the onset of the movement cue.
干预措施: in-house developed transcutaneous auricular Vagus Nerve Stimulation device (Device)
during-movement taVNS
Stimulation will occur during the movement phase.
干预措施: in-house developed transcutaneous auricular Vagus Nerve Stimulation device (Device)
post-movement taVNS
Stimulation will occur immediately after a successful trial (no stimulation if the trial is failed).
干预措施: in-house developed transcutaneous auricular Vagus Nerve Stimulation device (Device)
结局指标
主要结局
Success of the sensorimotor challenge
时间窗: 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).
Subjectively perceived tolerance of taVNS and perceived difficulty of motor task
时间窗: 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.
Mean Change from Baseline in Galvanic Skin Response (GSR)
时间窗: During and immediately after taVNS
Physiological dose response to the taVNS using GSR as indicator
Mean Change from Baseline in Pupil Diameter (PD)
时间窗: During and immediately after taVNS
Physiological dose response to the taVNS using PD as indicator
Mean Change from Baseline in electroencephalogram (EEG)
时间窗: During and immediately after taVNS
Physiological dose response to the taVNS using EEG as indicator
Mean Change from Baseline in Heart Rate (HR)
时间窗: During and immediately after taVNS
Physiological dose response to the taVNS using HR as indicator
次要结局
- Associations between outcomes(upon completion of study, at 2 weeks)
- Subjectively perceived positive effects of taVNS on motor performance(After each session, from enrollment to end of treatment at 2 weeks)
- Change of movement parameters from baseline(After each session, from enrollment to end of study at 2 weeks)
研究者
Olivier Lambercy
Adjunct Professor at the Department of Health Sciences and Technology and Co-Director of the Rehabilitation Engineering Laboratory
Swiss Federal Institute of Technology