Non-invasive Brain Stimulation for Post-Traumatic Stress Disorder
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Functional Connectivity changes as assessed by fMRI images
研究概览
简要总结
This study is designed to identify changes in the brain that underlie symptoms of combat-related PTSD using brain imaging (fMRI). Then, the investigators will administer mild electrical stimulation to the side of the head (using a method called tDCS) in an attempt to reduce the symptoms of PTSD.
详细描述
Being involved in combat is a horrific experience that substantially increases the risk of developing posttraumatic stress disorder (PTSD). Although several effective treatments have been identified for PTSD a substantial number of patients (up to 50%) continue to experience symptoms. The field of neuroscience has revealed that patients with PTSD demonstrate altered functioning within, and interactions between, several brain regions; findings that are consistent with animal models of chronic stress. Despite this evidence, existing treatments are generally not designed using this neuroanatomical knowledge. The central premise of the proposed study is that neuroscientifically-based information can be used to develop more precise and effective treatments. Transcranial direct current stimulation (tDCS) will be used in an attempt to "correct" the dysfunctional brain regions (and communication between these regions), with the expectation that this modulation will result in symptom improvement.
The primary goals of the study are to verify the maladaptive brain networks and then establish evidence that tDCS modulates these networks. Subsequent studies, performed during the later study years, will examine dose-response relationships and synergistic effects of tDCS and existing treatments. Outcome will be assessed using a multi-method approach that includes functional connectivity using resting-state functional magnetic resonance imaging data, neuropsychological tests, and self-report measures of emotional functioning. The combined results will provide vital methodological, mechanistic, and practical information necessary for a formal clinical trial of tDCS in 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 88 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Combat Veteran - both Veterans with and without PTSD will be included at different points in this study
- •Right-handed
- •Between the ages 18-88
- •Stable on medications for a minimum of 2 weeks
排除标准
- •a history of neurological disease (e.g., dementia, epilepsy, stroke, moderate - severe traumatic brain injury)
- •"severe" Axis I diagnoses (e.g., bipolar disorder, schizophrenia)
- •presence of Axis II disorders
- •current alcohol or drug abuse/dependence (in the past 8 weeks)
- •participants will also be excluded if they are not MRI compatible (assessed using the guidelines of the American College of Radiology)
- •Imminent risk of harm to self or others
- •history of HIV or sickle cell anemia, as these can cause neuropsychological issues .
研究组 & 干预措施
active tDCS
Investigators will use cathodal tDCS to inhibit the brain regions that may be associated with symptoms of PTSD (temporal cortex). Active tDCS will be provided at 2 miliamps (mA) for 20 minutes (with gradual increase and withdraw of stimulation during the first and last minute).
干预措施: Active tDCS (Device)
sham tDCS
Participants randomized to the sham condition will receive stimulation during the first and final minutes of the 20 minute period (with gradual increase and removal of current during that time).
干预措施: Sham tDCS (Device)
Combat Controls
Participants without PTSD will undergo neuropsychological testing and a single fMRI scan.
结局指标
主要结局
Functional Connectivity changes as assessed by fMRI images
时间窗: Pre and post tDCS; typically within 4 weeks
Investigators will use the fMRI images taken from before and after tDCS to determine if the treatment intervention contributed to any changes within the neural networks associated with the symptoms of PTSD.
次要结局
- Symptomatic changes as assessed by structured questionnaires (CAPS)(Pre and post tDCS; typically within 4 weeks)
- Symptomatic changes as assessed by structured questionnaires (Hamilton Depression Rating Scale)(Pre and post tDCS; typically within 4 weeks)
- Symptomatic changes as assessed by structured questionnaires (PCL-C)(Pre and post tDCS; typically within 4 weeks)
- Symptomatic changes as assessed by structured questionnaires (State-trait anxiety inventory)(Pre and post tDCS; typically within 4 weeks)
- Cognitive changes as assessed by Neuropsychological testing(Pre and post tDCS; typically within 4 weeks)
研究者
Benjamin Hampstead, PhD
Investigator
University of Michigan
