CAMSAN: Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Flanker Task Performance
研究概览
简要总结
The goal of this clinical trial is to extend this period of optimal cognitive performance by applying neurostimulation to buffer health volunteers against the effects of increased levels of stress, distraction, and cybersickness. The main questions it aims to answer are:
- Can we use OpenBCI's head-mounted Galea biosensor + eXtended Reality (XR) platform to measure participants' cognitive state in relation to stress, attention and cybersickness?
- How does applying external neurostimulation via Spark Biomedical's Sparrow Link transcutaneous auricular neurostimulation (tAN) system enhance cognitive performance with a closed-loop interface that automatically applies neurostimulation as a function of physiologically determined stress, attention, and cybersickness metrics?
Researchers will compare the active neurostimulation group to the sham neurostimulation group to see if cognitive performance is improved with stimulation.
Participants will complete 4 virtual reality tasks in the lab:
- 2 tasks related to attention - Flanker and Gradual-onset Continual Performance Task (GradCPT)
- The Multi-Attribute Task Battery (MATB)
- A cybersickness task
- And a baseline session before each task
- Neurostimulation intervention will occur in response to cognitive states
详细描述
The objective of this study is to determine if active tAN stimulation can form a closed-loop system with the Galea biosensing headset to enhance cognitive performance. The study is designed as a randomized, blinded, sham-controlled trial to test the effects of active tAN stimulation in cognitive stimulation tasks (Flanker task, GradCPT, MATB and cybersickness tasks) towards improvement of cognitive performance.
The study occurs in three phases.
- Phase I is designed to establish a quantifiable relationship between biometric data and cognitive states (cognitive load, stress, attention and cybersickness) under cognitive stimulation tasks (Flanker task, GradCPT, MATB and cybersickness tasks).
- Phase II involves evaluation of manual tAN to affect cognitive state in an open-loop paradigm.
- The third phase involves using the cognitive state quantification from Phase I, and the quantified effects of tAN discovered in Phase II to examine a closed-loop cognitive augmentation system.
Preliminary Cognitive State Assessment:
Phase I of the experiment will establish a cognitive task performance baseline, and also allow for quantification of cognitive state metrics based on biomarkers. Participants will perform the following tasks: Flanker Task, GradCPT, MATB, and a cybersickness stimulation task. Each of these tasks have different quantification and scoring systems to evaluate performance, and each aim to induce different cognitive stimulation. Before each task, an idle baseline of cognitive state is recorded.
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
- Double (Participant, Investigator)
盲法说明
Participants, research assistants and study investigator will be blind. Only the study coordinator will be aware of research groups.
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 human subjects between the ages of 18 and 55
- •Normal color vision and near visual acuity of 20/30 without correction.
- •Participant is right-hand dominant
- •Proficient in the English language
- •Ability to understand the explanations and instructions given by the study personnel
排除标准
- •Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
- •Participant is participating in another interventional trial within 90 days prior to or throughout duration of trial
- •Participant has a prior diagnosis of post-traumatic stress disorder, acute stress disorder, or generalized anxiety disorder
- •Participant has a diagnosis of attention deficit hyperactivity disorder (ADHD) and/or is currently taking medications for the treatment of ADHD.
- •Current or recent history of substance abuse or drug dependence including nicotine and alcohol, or use of mind-altering drugs in the past 30 days.
- •Participant has abnormal ear anatomy, ear infection present, or ear piercing that could interfere with stimulation
- •Participant has a recent history of epileptic seizures; including photosensitive epilepsy
- •Participant has a recent history of neurologic diseases or traumatic brain injury
- •Participant has presence of implanted medical devices (e.g., pacemakers, cochlear prostheses, neurostimulators)
- •Females who are pregnant or lactating
- •Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
- •Sensitivity to bright screens or virtual reality displays
- •Recent history of neurological and psychiatric disease/disorder
研究组 & 干预措施
Sham Stimulation
The sham group will receive a device but no stimulation will be delivered.
干预措施: Sham Stimulation (Device)
Active tAN
This group receives active neurostimulation at different intervals, amplitudes, and frequencies via the Sparrow Link device.
干预措施: Active Neurostimulation (Device)
结局指标
主要结局
Flanker Task Performance
时间窗: Baseline, pre-intervention, and during the intervention phases
Performance will be measured by number of correct responses and reaction time. Specially we will look at mean change in score (percentage of correct responses) and reduction in reaction time.
GradCPT Task Performance
时间窗: Baseline, pre-intervention, and during the intervention phases
Performance will be measured by number of correct responses and reaction time. Specially we will look at mean change in score (percentage of correct responses) and reduction in reaction time.
MATB Task Performance
时间窗: Baseline, pre-intervention, and during the intervention phases
Performance will be measured by number of correct responses and performance in the resource management task. Specially we will look at mean task completion percentage and root mean squared error in resource management task.
Cybersickness Task Performance
时间窗: Baseline, pre-intervention, and during the intervention phases
Performance will be measured by time in experiment. Specifically we will look at mean time before cybersickness symptoms present and mean time before participants voluntarily discontinue the experiment.
次要结局
- Bedford Work Scale Responses(Baseline, pre-intervention, and during the intervention phases)
- Simulator Sickness Questionnaire (SSQ) Responses(Baseline, pre-intervention, and during the intervention phases)
- Baxter Retching Faces (BARF) Responses(Baseline, pre-intervention, and during the intervention phases)