Modulation of Frontal Cortical Activity With Transcranial Static Magnetic Field Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Electroencephalogram (EEG) Spectral Power
研究概览
简要总结
The purpose of this study is to see if a new brain stimulation technique, static magnetic field stimulation (tSMS), which involves holding a static neodymium magnet over the scalp, can influence normal rhythms of brain activity.
详细描述
The investigator's primary objective is to determine the feasibility of modifying frontal brain activity using static magnetic fields. The investigator's will be examining the effects of static magnetic field of the spectral power of EEG data with healthy human participants.
This is a within-subjects design, where each participant will receive sham and active stimulation on the left and right frontal cortex. EEG data will be collected during each stimulation.
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 providing the study coordinator with the active and sham magnet sequence. Each magnet has a number; the study coordinator is not aware which number corresponds to active or sham magnets.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right-handed, healthy, 18+ years old
- •Capacity to understand all relevant risks and potential benefits of the study (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
- •Medical history of Psychological/Emotional Disorders (depression, anxiety, bipolar, etc.)
- •(For females) Pregnancy or breast feeding
- •Diagnosis of eating disorder (current or within the past 6 months)
- •Diagnosis of Obsessive-Compulsive Disorder (lifetime) 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)
- •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, HIV/AIDS, malignancy, liver or renal impairment)
- •Prior brain surgery Any brain devices/implants, including cochlear implants and aneurysm clips
- •Any metal in/on the body, e.g., dental braces, glasses, piercings
- •Traumatic brain injury
- •Thick hair that would create distance between the magnet and the scalp
- •Taking hormonal birth control or hormonal supplements (e.g., testosterone injections) - 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
Left Frontal
An active magnet (active tSMS) will be placed over the left frontal cortex, while a sham magnet (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the right frontal cortex.
干预措施: Active tSMS (Other)
Right Frontal
An active magnet (active tSMS) will be placed over the right frontal cortex, while a sham magnet (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left frontal cortex.
干预措施: Active tSMS (Other)
Sham Frontal
Sham magnets (sham tSMS, a nonmagnetic metal cylinder made of brass) will be placed over the left and right frontal cortex.
干预措施: Sham tSMS (Other)
结局指标
主要结局
Electroencephalogram (EEG) Spectral Power
时间窗: 4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation
Changes in the spectral power of the EEG before (2 min eyes-closed, 2 min eyes-open), during (eyes-open), and after stimulation (eyes-open)
次要结局
- Heart Rate Variability(4 minutes before stimulation, 10 minutes during stimulation, and 2 minutes after stimulation)