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临床试验/NCT07451093
NCT07451093尚未招募不适用

Epileptiform Potential of Fully Immersive Virtual Reality

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Change in prevalence of interictal epileptiform discharges

研究概览

简要总结

The goal of this interventional study is to determine if the use of virtual reality headsets results in an increased risk of seizure in adolescent and adult individuals with epilepsy. The main question it aims to answer are:

- does use of virtual reality headsets with hand controllers result in a higher risk of seizure compared to use of virtual reality headsets without hand controllers Participants will be asked to wear a virtual reality headset during continuous video EEG recording and EEG with be evaluated during three phases: with display turned off, with display turned on without hand controllers, and with display turned on with hand controllers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects with known or suspected diagnosis of epilepsy with interictal epileptiform discharges seen during current or prior EEG recording
  • Age greater than or equal to 13 years

排除标准

  • Age less than 13 years (infants, children)
  • Pregnancy
  • Incarceration
  • Moderate-severe cognitive impairment

研究组 & 干预措施

Virtual Reality Arm

Experimental

Participants wear VR headset during video EEG recording for a total of 3 sessions, each lasting 15 minutes each.

干预措施: Virtual Reality Headset, display off (Other)

Virtual Reality Arm

Experimental

Participants wear VR headset during video EEG recording for a total of 3 sessions, each lasting 15 minutes each.

干预措施: Virtual Reality Headset, Display only (Other)

Virtual Reality Arm

Experimental

Participants wear VR headset during video EEG recording for a total of 3 sessions, each lasting 15 minutes each.

干预措施: Virtual Reality Headset, Display and Hand Control (Other)

结局指标

主要结局

Change in prevalence of interictal epileptiform discharges

时间窗: Three sessions, 15 minutes each

Interictal epileptiform discharges are counted by two epilepsy trained neurologists. Number of discharges seen are compared between each intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jared.E.Quast

Principal Investigator

Dartmouth-Hitchcock Medical Center

研究点 (1)

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