跳至主要内容
临床试验/NCT04579653
NCT04579653撤回不适用

Effects of Various Non-invasion Stimulation Parameters on Pupil Dilation

University of Florida1 个研究点 分布在 1 个国家开始时间: 2023年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Ocular response after transcutaneous nerve stimulation

研究概览

简要总结

This project will apply non-invasive, trans-cutaneous vagal nerve stimulation using various stimulation parameters to young, healthy adults to find the optimal set of parameters to elicit pupil response.

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
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Fluent English speaker with reading and writing proficiency.

排除标准

  • •Participants with significant visual impairment or ocular illness may be excluded at the discretion of the principal investigator.
  • •Major medical illnesses including severe neurological illness (e.g. stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia)
  • •Any history of brain surgery, tumor, intracranial metal implantation, pacemakers, or other implanted devices.
  • •Current (i.e. within 48 hours of the session) prescription medication or over-the-counter medication use.
  • •Illicit alcohol or drug use. Caffeine (e.g, coffee, energy drinks) consumption prior to the visit.

研究组 & 干预措施

Group A: Experimental

Experimental

Within-subjects design with a randomization of the order of tVNS administered parameters

干预措施: transcutaneous electrical nerve stimulation devices (Device)

Group B: Active Comparator

Active Comparator

Within-subjects design with a randomization of the order of tVNS administered parameters

干预措施: transcutaneous electrical nerve stimulation devices (Device)

结局指标

主要结局

Ocular response after transcutaneous nerve stimulation

时间窗: Visit 1 day

Number of participants with pupil response after transcutaneous nerve stimulation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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