跳至主要内容
临床试验/NCT03800030
NCT03800030已完成不适用

A Pilot Study Investigating the Effects of Cross Frequency Transcranial Alternating Current Stimulation on Cortical Oscillations Underlying Cognition

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Reaction Time for Trials With High Abstraction Relative to Low Abstraction

研究概览

简要总结

Investigation of frequency specific transcranial alternating current stimulation on cognitive control signals in frontal cortex

详细描述

Previous evidence suggests that there are specific frequency bands associated with different aspects of cognitive control. In specific delta (2-4Hz) and beta (15-30Hz) are associated with increased levels of abstraction for learned rules; and theta (5-8Hz) and gamma (30-50Hz) has been associated with increased set-size or number of learned rules. Here we aim to find causal evidence in support of these previous correlational findings by applying cross-frequency transcranial alternating current stimulation (tACS) in the specific frequency bands previously shown to be task-relevant. In a crossover design, we stimulate subjects with either delta-beta or theta-gamma tACS during performance of a hierarchical cognitive control task that manipulates the level of abstraction and set-size of rules that must be learned in order to make the correct button press.

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

Double-blinded. Neither the investigator nor the participants knows which form of stimulation is received.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Between the ages of 18 and 35 years
  • •Able to provide informed consent
  • •Willing to comply with all study procedures and be available for the duration of the study Speak and understand English

排除标准

  • •Attention Deficit Hyperactivity Disorder (currently under treatment)
  • •Neurological disorders and conditions, including, but not limited to:
  • •History of epilepsy
  • •Seizures (except childhood febrile seizures and electroconvulsive therapy induced seizures) Dementia
  • •History of stroke
  • •Parkinson's disease
  • •Multiple sclerosis
  • •Cerebral aneurysm
  • •Brain tumors
  • •Medical or neurological illness or treatment for a medical disorder that could interfere with study participation (e.g., unstable cardiac disease, malignancy)
  • •Prior brain surgery
  • •Any brain devices/implants, including cochlear implants and aneurysm clips
  • •History or current traumatic brain injury
  • •(For females) Pregnancy or breast feeding
  • •Personal or family history of mental/psychiatric disorder (e.g., anxiety, major depressive disorder, schizophrenia, etc.)
  • •Positive urine test for the following: Marijuana (THC), Cocaine (COC), Phencyclidine (PCP), Amphetamine (AMP), Ecstasy (MDMA), Methamphetamine (Mamp), Opiates (OPI), Oxycodone (OXY), Methadone (MTD), Barbiturates (BAR), Benzodiazepines (BZO), Buprenorphine (BUP), Tricyclic Antidepressants (TCA), Propoxyphene (PPX)
  • •Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study

研究组 & 干预措施

Theta-gamma, Delta-beta, Sham

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Theta-gamma tACS, then Delta-beta tACS, then Sham tACS

干预措施: Theta-gamma tACS (Device)

Theta-gamma, Delta-beta, Sham

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Theta-gamma tACS, then Delta-beta tACS, then Sham tACS

干预措施: Delta-beta tACS (Device)

Theta-gamma, Delta-beta, Sham

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Theta-gamma tACS, then Delta-beta tACS, then Sham tACS

干预措施: Sham tACS (Device)

Theta-gamma, Sham, Delta-beta

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Theta-gamma tACS, then Sham tACS, then Delta-beta tACS

干预措施: Delta-beta tACS (Device)

Theta-gamma, Sham, Delta-beta

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Theta-gamma tACS, then Sham tACS, then Delta-beta tACS

干预措施: Theta-gamma tACS (Device)

Theta-gamma, Sham, Delta-beta

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Theta-gamma tACS, then Sham tACS, then Delta-beta tACS

干预措施: Sham tACS (Device)

Delta-beta, Theta-gamma, Sham tACS

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Delta-beta tACS, then Theta-gamma tACS, then Sham tACS

干预措施: Theta-gamma tACS (Device)

Delta-beta, Theta-gamma, Sham tACS

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Delta-beta tACS, then Theta-gamma tACS, then Sham tACS

干预措施: Delta-beta tACS (Device)

Delta-beta, Theta-gamma, Sham tACS

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Delta-beta tACS, then Theta-gamma tACS, then Sham tACS

干预措施: Sham tACS (Device)

Delta-beta, Sham, Theta-gamma tACS

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Delta-beta tACS, then Sham tACS, then Theta-gamma tACS

干预措施: Sham tACS (Device)

Delta-beta, Sham, Theta-gamma tACS

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Delta-beta tACS, then Sham tACS, then Theta-gamma tACS

干预措施: Theta-gamma tACS (Device)

Delta-beta, Sham, Theta-gamma tACS

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Delta-beta tACS, then Sham tACS, then Theta-gamma tACS

干预措施: Delta-beta tACS (Device)

Sham, Delta-beta, Theta-gamma tACS

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Sham tACS, then Delta-beta tACS, then Theta-gamma tACS

干预措施: Theta-gamma tACS (Device)

Sham, Delta-beta, Theta-gamma tACS

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Sham tACS, then Delta-beta tACS, then Theta-gamma tACS

干预措施: Delta-beta tACS (Device)

Sham, Delta-beta, Theta-gamma tACS

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Sham tACS, then Delta-beta tACS, then Theta-gamma tACS

干预措施: Sham tACS (Device)

Sham, Theta-gamma, Delta-beta tACS

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Sham tACS, then Theta-gamma tACS, then Delta-beta tACS

干预措施: Theta-gamma tACS (Device)

Sham, Theta-gamma, Delta-beta tACS

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Sham tACS, then Theta-gamma tACS, then Delta-beta tACS

干预措施: Delta-beta tACS (Device)

Sham, Theta-gamma, Delta-beta tACS

Experimental

Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.

Sequence: Sham tACS, then Theta-gamma tACS, then Delta-beta tACS

干预措施: Sham tACS (Device)

结局指标

主要结局

Reaction Time for Trials With High Abstraction Relative to Low Abstraction

时间窗: through study completion, an average of 3 weeks

For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis.

Theta Phase to Gamma Amplitude Coupling Strength

时间窗: through study completion, an average of 3 weeks

Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution.

Reaction Time for Trials With High Set-size Relative to Low Set-size

时间窗: through study completion, an average of 3 weeks

The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis.

Percent Correct for Trials With High Abstraction Relative to Low Abstraction

时间窗: through study completion, an average of 3 weeks

For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis.

Percent Correct for Trials With High Set-size Relative to Low Set-size

时间窗: through study completion, an average of 3 weeks

The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis.

Delta Phase to Beta Amplitude Coupling Strength

时间窗: through study completion, an average of 3 weeks

Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution.

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)

Loading locations...

相似试验