Investigation of Vagus Nerve Stimulation to Augment Executive Functioning
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Lack of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This study plans to learn more about how stimulating the vagus nerve through gentle electrical stimulation applied to the ear can affect decision-making, problem-solving, and other thinking abilities. This process, called transcutaneous auricular vagus nerve stimulation (taVNS), could help improve brain function in both healthy individuals and people with Parkinson's disease (PD).
详细描述
This is a single-site pilot study to assess the safety, feasibility, and potential therapeutic effect of paired-taVNS cognitive training in healthy individuals and people with PD. In the longitudinal study, healthy and PD participants will be prospectively assigned to receive either the sham or active intervention based on order of enrollment in the study. In the acute study, healthy participants will receive both the sham and active intervention, where the order will be prospectively randomized based on order of enrollment in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 18-
- •Ability to sign informed consent.
- •Ability to follow written and verbal instructions.
- •For the PD group, a clinical diagnosis of Parkinson's disease without severe motor or cognitive impairments.
排除标准
- •Current uncontrolled and/or clinically significant medical condition.
- •Abnormal ear anatomy or active ear infection.
- •Electronic medical implants, such as pacemakers, cochlear prosthesis, neuro-stimulators.
- •Uncorrected visual impairments that would interfere with task performance.
- •(6) Other significant diseases or disorders that might impair study participation.
研究组 & 干预措施
active stimulation (healthy controls)
Healthy participants in this arm will receive active transcutaneous auricular vagus nerve stimulation
干预措施: transcutaneous auricular vagus nerve stimulation (Device)
sham stimulation (healthy controls)
Participants in this arm will receive sham stimulation that does not target the vagus nerve
干预措施: sham stimulation (Device)
active stimulation (Patients with Parkinson's Disease)
Participants with PD in this arm will receive active transcutaneous auricular vagus nerve stimulation
干预措施: transcutaneous auricular vagus nerve stimulation (Device)
sham stimulation (patients with Parkinson's Disease)
Participants with PD in this arm will receive sham stimulation that does not target the vagus nerve
干预措施: sham stimulation (Device)
结局指标
主要结局
Lack of adverse events (AEs) and serious adverse events (SAEs)
时间窗: From enrollment to the end of treatment at 6 months
a lack of AEs and SAEs during the paired-taVNS intervention
次要结局
- Cognitive Task Performance(From enrollment to the end of treatment at 6 months)
- Executive Function network modulation(From enrollment to the end of treatment at 6 months)
- Subjective experience(From enrollment to the end of treatment at 6 months)