Forgetting Fear: Establishing a Novel Non-invasive Approach to Disrupt Fear-based Sensory Memory Consolidation in Humans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Changes in Neural Connections: Functional network connectivity
研究概览
简要总结
This project represents a unique collaborative opportunity to pursue the essential proof-of-principle demonstration that non-invasive interference of sensory cortical memory consolidation shortly after an emotional experience can attenuate the cued fear response and potentially reduce the risk of developing post-traumatic stress disorder (PTSD). If successful, the study results would anchor a potential advance in the treatment of patients after a traumatic event and seed future animal and clinical studies of emotional sensory cortical memory consolidation to reduce the prevalence and negative sequelae of PTSD.
详细描述
This mechanistic study in humans will study an unexplored precision-based approach of non-invasive neuromodulation of sensory cortex with the aim to prevent PTSD by attenuating the sensory encoding of fear memory. The objective of this project is to explore the basic science and therapeutic potential of sensory-emotional reprogramming in humans, and translate this idea into a precise, individualized treatment to reduce the risk that negative emotional sensory experiences lead to PTSD. Understanding sensory-emotional programming in humans could anchor a breakthrough in the treatment of patients after a traumatic event and seed future animal and clinical studies of emotional sensory cortical memory consolidation to reduce the prevalence and negative sequela of PTSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent
- •Willingness to participate in study
- •No history of musculoskeletal impairment or neurological disease
- •Clinical diagnosis of PTSD for individuals in the PTSD group.
排除标准
- •Any participant outside the age range
- •Participants that show signs of dementia (score < 20 on the Montreal Cognitive Assessment)
- •Participants that have a history of major head trauma, a neurodegenerative disorder, or recent (<6 months) substance abuse;
- •Participants that had a recent history of Central Nervous System (CNS) active drugs that may influence cortical excitability or learning; or
- •Participants that report contraindications to TMS or MRI - if participating in the TMS/MRI experiments
- •Current psychoactive medication usage
- •Current symptoms of psychosis or bipolar disorder (as indicated by study staff through a clinical interview as part of that study).
- •The study will exclude adults unable to consent, individuals who are not yet adults, pregnant women and prisoners on scientific grounds and to minimize risk.
结局指标
主要结局
Changes in Neural Connections: Functional network connectivity
时间窗: Study Day 30 and Day 31
Preprocessing of neuroimaging data will be conducted using fMRI prep. Pre-processed neuroimaging data will undergo first and second level modeling in Statistical Parametric Mapping. First level analysis include an event-related model with the onset and duration of each event included for each condition, and motion included as a regressor. A high-pass filter of 128s will be applied to account for low-frequency drifts. Amygdala regions of interest (ROIs) will be defined anatomically using California Institute of Technology (CIT168) Subcortical Atlas. Primary sensory cortex ROI \& seed coordinates will be defined utilizing voxels within a V1 region mask showing maximal functional connectivity with the amygdala during conditioning.
Changes in Neural Connections: Regional activation
时间窗: Study Day 30 and 31
Preprocessing of neuroimaging data will be conducted using fMRI prep. Pre-processed neuroimaging data will undergo first and second level modeling in Statistical Parametric Mapping. First level analysis include an event-related model with the onset and duration of each event included for each condition, and motion included as a regressor. A high-pass filter of 128s will be applied to account for low-frequency drifts. Whole-brain analysis of changes in local regions of activity will be measured by change in blood-oxygen-level-dependent (BOLD) signal from resting activity. Multiple comparisons using permutation-based methods to control the false positive rate to p\<.05.
次要结局
- ECG(Study Day 31)
- Acoustic Startle response(Study Day 31)
- Changes in Measures of skin conductive response(Study Day 30 and Day 31)
- Changes in Fear conditioning and extinction task(Study Day 30 and Day 31)
研究者
Michael R Borich
Associate Professor
Emory University