The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood: An fMRI/MRS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits
研究概览
简要总结
Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in brain activity.
详细描述
The advent of an appreciation that alternative and complementary practices can have some beneficial effect on health has prompted the question of whether there are empirical measures of improvement that do not rely solely on subjective reports. The present study proposes to explore whether transcranial stimulation (or cranial electrotherapy stimulation; CES) using an FDA-approved device can alter brain function, mood and responses to cognitive tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21 to 55 years old
- •Otherwise physically healthy (normal physical exam, ECG, blood and urine chemistries)
- •Female participants must use medically approved method of contraception. If barrier method is used, they must agree to using two methods simultaneously (e.g., diaphragm and condom).
- •If on antidepressant or antianxiety medication, must be on a stable prescription regimen with no intentions to change drugs or dose during the next 11 weeks.
排除标准
- •Opiate maintenance (e.g., methadone or buprenorphine)
- •Drug use (other than nicotine, alcohol, or marihuana) greater than 50 lifetime uses.
- •Meets criteria for current drug abuse or dependence (other than nicotine, alcohol, or marihuana). Past abuse/dependence (greater than 3 years) is acceptable.
- •Meets criteria for alcohol dependence. Past abuse/dependence (greater than 3 years) is acceptable. They may meet criteria for alcohol abuse.
- •Physical health problems
- •History of significant cardiac problems
- •History of seizures
- •Pregnancy
- •Persons with a demand-type cardiac pacemaker
- •Persons receiving vagus nerve simulation
- •Persons receiving deep brain stimulation
- •Participants cannot have any conditions that are contraindicated for MRI
研究组 & 干预措施
Active stimulation
The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.
干预措施: Fisher Wallace Cranial Stimulator (Device)
Sham stimulation
Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.
干预措施: Fisher Wallace Cranial Stimulator (Device)
结局指标
主要结局
BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits
时间窗: within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment
Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment. The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption.
次要结局
- Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm(within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment)
- Change in Visual Analogue Scale (VAS) in Active Stimulation Arm(within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment)
- BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only(within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment)
研究者
Scott Lukas
Director, McLean Imaging Center
Mclean Hospital