Testing a Neurocognitive Model of Distancing Using Transcranial Magnetic Stimulation.
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
- Change in Self-reported Valence (Distancing) From Baseline to 30 Minutes Post Stimulation.
研究概览
简要总结
Distancing oneself from a current distressing situation is a mental skill that can help people to manage their emotions. However, little is known about how distancing works in the brain. Recently developed tools in neuroscience that can modify brain activity might be able to make distancing more or less effective. In doing so, the results could lead to a better understanding of the cognitive processes and neural circuits that support distancing as a form of emotion regulation. If successful, this research may lead to the development of new treatments to help those who suffer from stress-related disorders, such as anxiety and depression.
详细描述
Distancing is an emotion regulation skill that relies in part on self-projection, or the ability to shift perspective from the here and now to a simulated time, place, or person. Based on prior review and meta-analysis of the distancing literature, a new model has been developed of the neurocognitive processes that support distancing. The proposed experiment will test the model causally through a neural intervention that should impair or enhance the ability of healthy adults to successfully apply distancing to down-regulate negative affect. In the model, it is hypothesized that the temporoparietal junction (TPJ) was a key region mediating the self-projection aspect of distancing. Leveraging recent functional magnetic resonance imaging (fMRI) work, the experiment will functionally modulate this region through inhibitory transcranial magnetic stimulation (TMS) to test its causal role in distancing. Importantly, the proposed work shifts emphasis from traditional models of emotion regulation, which implicate frontal executive control mechanisms, to new cognitive processes and brain targets that can ultimately lead to novel approaches to treat affective disorders.
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
Neither the lead experimenter nor the subject will know which arm they will complete first. The secondary experimenter will use a randomized counter-balanced log to determine the order of sequences will take place. The secondary experimenter will set up the device while the lead experimenter is out of the room to preserve blindness to the intervention.
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-39 years inclusive
- •Willing to provide informed consent
- •English speaking
- •Signed HIPAA authorization
排除标准
- •Current or recent (within the past 6 months) substance abuse or dependence, excluding nicotine and caffeine (assessed via urine test).
- •Current serious medical illness (assessed via self report).
- •History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by TMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator) [assessed via TMS Adult Safety Screening form].
- •Subjects are unable or unwilling to give informed consent.
- •Diagnosed any Axis I Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) disorder (assessed via self report).
- •Subjects with a clinically defined neurological disorder (assessed via self report) including, but not limited to:
- •Any condition likely to be associated with increased intracranial pressure
- •Space occupying brain lesion.
- •History of stroke.
- •Transient ischemic attack within two years.
- •Cerebral aneurysm.
- •Parkinson's disease.
- •Huntington's disease.
- •Multiple sclerosis.
- •Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold (assess via self report).
- •Subjects not willing to tolerate the confinement associated with being in the MRI scanner.
- •Women who are pregnant or breast-feeding (assessed via urine test).
- •Blindness.
- •Inability to read or understand English.
- •Intracranial implants, such as:
- •Cochlear implants;
- •Aneurysms clips;
- •Stimulators;
- •Electrodes;
- •Cardiac pacemakers;
- •Vagus Nerve stimulation devices.
结局指标
主要结局
Change in Self-reported Valence (Distancing) From Baseline to 30 Minutes Post Stimulation.
时间窗: baseline, 30 minutes post stimulation
Valence is how positive or negative a subject feels. Subjects will be asked to rate how they feel on a 7 point Likert scale ranging from 1 (very negative) to 7 (very positive) after using an emotion regulation technique (distancing) when shown graphic stimuli.
次要结局
- Change in Self-reported Effort (Distancing) From Baseline to 30 Minutes Post Stimulation.(baseline, 30 minutes post stimulation)