Personalized Neuromodulation Targeting Dysregulated Motivational Responses Underlying Social Avoidance Behavior
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Neural circuit function
研究概览
简要总结
The purpose of this study is to use transcranial magnetic stimulation (TMS) to better understand the neural circuits associated with social motivation.
Participant includes four study visits each that range from 1.5 - 3.0 hours in duration over approximately a one month period. The first study visit involves answering survey questions, a clinical interview, and computer tasks. The second study visit involves a magnetic resonance imaging (MRI) scan, computer tasks, and a brief TMS protocol. The second and third study visits involve a full session of TMS followed by an MRI scan and computer tasks.
Adults in the Auburn/Opelika area and surrounding areas who avoid social situations, experience symptoms of depression or social anxiety, and are between 25 years old and 50 years old are eligible to participate.
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)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of Major Depressive Disorder OR a diagnosis of Social Anxiety Disorder (assessed/confirmed at screening visit).
- •Scoring above clinical threshold on a measure of social avoidant behavior (assessed/confirmed at phone screen).
排除标准
- •Unstable psychotropic medication regimen (i.e., changes in psychotropic medication or dosage in past 3 months).
- •Current or lifetime diagnosis of Bipolar Disorder.
- •A diagnosis of substance use disorder within past 12 months.
- •A diagnosis of psychotic-spectrum disorder such as Schizophrenia.
- •Pregnancy or probable pregnancy.
- •Medical illness or medical treatment that would preclude or inhibit study participation.
- •Neurological disorder associated with brain damage.
- •History of seizures or head trauma with loss of consciousness > 5 minutes.
- •Family history of epilepsy or personal epilepsy/seizures
- •Ferromagnetic implants or ferrmagnetic objects within body (e.g., pacemaker).
研究组 & 干预措施
TMS A
Active continuous thetaburst stimulation administered over right dorsolateral prefrontal cortex for 40 seconds (600 pulses total)
干预措施: TMS (Device)
TMS B
Sham continuous thetaburst stimulation administered over right dorsolateral prefrontal cortex for 40 seconds (600 pulses total)
干预措施: TMS (Device)
结局指标
主要结局
Neural circuit function
时间窗: Immediately post-intervention
Brain connectivity during motivational responses to facial expression during the Social Approach-Avoidance Paradigm (SAAP; Evans, Esterman, \& Britton, 2022) and during resting state conditions. In the SAAP, participants self-report how much they would like to approach or avoid emotional facial expressions. During resting state conditions, participants simply lie still with their eyes open without completing any type of task.
Social motivation
时间窗: Immediately post-intervention
Motivational responses to facial expressions as measured by the Social Approach Avoidance Paradigm (SAAP; Evans, Esterman, \& Britton, 2022). In the SAAP, participants self-report how much they would like to approach or avoid emotional facial expressions.
次要结局
未报告次要终点
研究者
Travis Evans
Assistant Professor
Auburn University