Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Processing speed (Simple reaction time task)
研究概览
简要总结
This study investigates the potential of cranial electrotherapy stimulation to mitigate anxiety induced cognitive deficits
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All study staff are blinded to active and sham brain stimulation devices until the completion of data collection.
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18-28 years old
排除标准
- •History of diagnosis with a neurological or psychiatric disorder.
研究组 & 干预措施
Experimental - Induced Anxiety
Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. Participants will be told they may receive additional shocks for poor performance during cognitive assessments.
Participants will be administered cranial electrotherapy stimulation with a frequency of .5 Hz and a current of 100 microamps during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).
干预措施: Cranial Electrotherapy Stimulation (Device)
Experimental - No Induced Anxiety
Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. After this procedure, the shock belt will be turned off. Participants will be told they will not receive additional shocks during cognitive assessments.
Participants will be administered cranial electrotherapy stimulation with a frequency of .5 Hz and a current of 100 microamps during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).
干预措施: Cranial Electrotherapy Stimulation (Device)
Sham - Induced Anxiety
Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. Participants will be told they may receive additional shocks for poor performance during cognitive assessments.
Participants will be administered sham cranial electrotherapy stimulation with no current during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).
干预措施: Sham Cranial Electrotherapy Stimulation (Device)
Sham - No Induced Anxiety
Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. After this procedure, the shock belt will be turned off. Participants will be told they will not receive additional shocks during cognitive assessments.
Participants will be administered sham cranial electrotherapy stimulation with no current during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).
干预措施: Sham Cranial Electrotherapy Stimulation (Device)
结局指标
主要结局
Processing speed (Simple reaction time task)
时间窗: 68 weeks
Mean reaction time
Task switching
时间窗: 68 weeks
Switch cost (mean switch reaction time- mean stay reaction time)
Working memory (N-back)
时间窗: 68 weeks
2-back condition mean accuracy
Inhibition (Stroop)
时间窗: 68 weeks
Stroop interference cost (mean incongruent reaction time- mean congruent reaction time)
次要结局
未报告次要终点
研究者
Nathan Ward
Associate Professor
Tufts University