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临床试验/NCT03135639
NCT03135639已完成不适用

Evaluating Transcranial Alternating Current Stimulation (tACS) for Enhancing Creativity

University of North Carolina, Chapel Hill0 个研究点目标入组 32 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
主要终点
Electroencephalogram power in alpha band

研究概览

简要总结

**Follow-up Control Study for Creativity Study

Purpose: To investigate the effect of transcranial alternating current stimulation (tACS), a form of noninvasive brain stimulation, in healthy subjects. This experiment is a follow-up to previous tACS studies that used a creativity assessment.

Participants: 35 males and females, at least 18 years of age, without history of major psychiatric/neurological disease or associated medication use, or prior brain surgery/implants.

Procedures (methods): This is a cross-over study design. Participants will undergo a control condition of stimulation (sham or individual alpha, 8-12 Hz, tACS) during electroencephalogram recordings. In addition, pupil diameter, heart rate, and respiration will be measured continuously. This is to study the physiological effects of stimulation.

详细描述

Participants will report for a study visit. They will review and sign a consent form.

They will first be fitted with two 5x7cm electrodes placed over occipital and parietal cortex (Cz and Oz). They will also be fitted with ECG electrodes as well as a respiration belt. In addition, they will have a 128-channel EEG net placed on their head and pupillometry glasses. Once the participant is fitted with this equipment, they will complete a 2-minute resting state EEG with their eyes closed to determine their individual alpha frequency. Following the individual alpha frequency determination, the participant will fill out an alertness questionnaire, followed by 3 EEG recordings:

  1. 5 minute before stimulation recording
  2. 20 minute recording during stimulation; either at their individual alpha frequency (between 8 and 12 Hz) or sham stimulation.
  3. 5 minute after stimulation recording

Following these three recordings, the participant will have a 20 minute break in which they will read neutral reading material or converse with the study staff, as well as provide a saliva sample to test for brain derived neurotropic factor (BDNF).

After the 20 minute break, the participant will complete the alertness questionnaire, and the three recordings will be completed again. The participant will then be allowed to clean up, be paid, and leave.

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
Double (Participant, Investigator)

盲法说明

This is a double-blind study, meaning that neither the participant nor the experimenter knows what kind of stimulation the participant is receiving. An unblinded monitor (separate from the staff that interacts with the participant) is responsible for creating the stimulation codes that run each session and for ensuring that these codes worked correctly.

入排标准

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

入选标准

  • Males and females at least 18 years of age

排除标准

  • History of major neurological or psychiatric illness, including epilepsy
  • Medication use associated with neurological or psychiatric illnesses
  • Currently undergoing counseling or psychotherapy treatment for depression, anxiety, eating disorders, PTSD, or other behavior conditions
  • First degree relative (parent, sibling, child) with neurological or psychiatric illness (past and present)
  • Prior brain surgery
  • Head injury
  • Any brain devices/implants (including cochlear implants and aneurysm clips)
  • Cardiovascular disease
  • Pregnancy

结局指标

主要结局

Electroencephalogram power in alpha band

时间窗: 5 minute recordings before and after each 20 minute stimulation session during a single study visit.

Changes in the EEG power in the alpha (8-12 Hz) band before and after stimulation sessions.

次要结局

  • Pupil diameter(5 minute recordings before and after each 20 minute stimulation session during a single study visit.)
  • Heart Rate Variability(5 minute recordings before and after each 20 minute stimulation session during a single study visit.)

研究者

申办方类型
Other
责任方
Sponsor

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