Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping
研究概览
简要总结
The goal of this study is to determine if a specific experimental brain stimulation technique can be used as a non-invasive way to reduce cigarette cravings in current smokers. This study plans to learn more about the way an experimental technique called "transcranial magnetic stimulation" (TMS) affects a specific part of the brain, called the insula. Some research suggests that this part of the brain plays an important role in craving. The investigators plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI) of subjects' brain.
For interested participants, this study requires a single 3 hour appointment, which will include MRI of the brain as well as TMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide informed consent
- •Self-reported current average daily cigarette consumption >10/day for at least 1 year
- •Self-reported motivation to quit smoking
排除标准
- •MRI/TMS exclusions, including
- •Claustrophobia
- •Intracranial or spinal hardware
- •Pacemakers
- •MR-incompatible devices (Examples: pacemaker, deep brain stimulator, vagal nerve stimulator, cochlear implant, insulin pump, implanted medication pump, bone stimulator, implanted defibrillator)
- •History of metal objects or fragments in the eye or skull, including shrapnel or metal plates
- •History of stroke or other brain lesion
- •History of attempted suicide or suicidal ideation
- •Personal history of headaches, seizures, epilepsy, or status epilepticus
- •Family history of epilepsy
- •Medications known to lower seizure threshold (e.g., tricyclic antidepressants, antipsychotics, psychostimulants)
- •Increased intracranial pressure, hydrocephalus, or pseudotumor cerebri
- •Unstable coronary artery disease
- •Current pregnancy or positive urine pregnancy test
- •Neurological illness
- •Prior neurosurgery
- •Schizophrenia
- •Bipolar disorder
- •Current (within the last two months) major depressive disorder
- •Substance dependence or positive urinalysis for opiates, stimulants, cannabis, or sedative on the day of testing
- •Alcohol dependence or positive breath test for alcohol on the day of testing
- •Use of tobacco products other than cigarettes.
结局指标
主要结局
Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping
时间窗: 1 hour
Changes in Cue-induced Cigarette Craving (Post-treatment - Pre-treatment) as Assessed by TCQ
时间窗: 1 hour
Cue-induced cigarette craving as assessed by Tobacco Craving Questionnaire (TCQ)
Changes in fMRI Connectivity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping
时间窗: 1 hour
次要结局
未报告次要终点