Effect of Transcutaneous Auricular Stimulation of the Vagus Nerve on Functional Connectivity in the Brain at Rest: fNIRS Study in Chronic Post-stroke Subjects and Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Resting-State Functional Connectivity
研究概览
简要总结
The goal of this clinical trial is to study the effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on resting-state brain functional connectivity. The study will assess this effect using functional Near-Infrared Spectroscopy (fNIRS) in both chronic post-stroke patients and healthy subjects.
The main questions it aims to answer are:
Does taVNS affect resting-state functional connectivity (measured by fNIRS) in chronic post-stroke patients?
Does taVNS affect resting-state functional connectivity (measured by fNIRS) in healthy subjects?
Are there differences in the effect of taVNS on functional connectivity between the post-stroke group and the healthy group?
Researchers will compare the effect of active taVNS (real stimulation) to a sham stimulation (control) to evaluate its specific impact on the brain's functional networks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •for post-stroke participant:
- •age 18 or older
- •Right-handed participant;
- •Hemiparesis in the chronic phase (>6 months post-stroke)
- •Participant who has agreed to sign an informed consent form;
- •Participant who is affiliated with social security.
- •Inclusion Criteria for healthy participant:
- •age 18 or older
- •Right-handed participant;
- •Participant who has agreed to sign an informed consent form;
- •Participant who is affiliated with social security.
排除标准
- •for post-stroke participant:
- •Allergy to neoprene (the material used to make the fNIRS cap);
- •Hair volume preventing the cap from being put on and/or access to the scalp;
- •Cognitive impairment making it impossible to participate in the study;
- •Phasic disorders preventing understanding of instructions and effective communication;
- •Pregnant or breastfeeding women;
- •Persons under legal protection
- •Exclusion Criteria for post-stroke participant:
- •Allergy to neoprene (the material used to make the fNIRS cap);
- •Hair volume preventing the cap from being put on and/or access to the scalp;
- •Pregnant or breastfeeding women;
- •Persons under legal protection
研究组 & 干预措施
Active taVNS arm
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Delivery of low-intensity electrical impulses to the outer ear (concha and tragus) to stimulate the auricular branch of the vagus nerve.
干预措施: Active taVNS arm (Device)
Sham Control arm
Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition.
干预措施: Sham Control arm (Device)
结局指标
主要结局
Resting-State Functional Connectivity
时间窗: Day 1
次要结局
未报告次要终点