sTMS for Substance Use-disordered Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)
研究概览
简要总结
The purpose of this study is to determine if synchronized transcranial magnetic stimulation is safe and tolerable in individuals with cocaine, opioid, or alcohol use disorders.
详细描述
All non-life-saving human research studies suspended by sponsor in response to COVID19 social distancing policies
The goal of this proposal is to evaluate preliminary participant response to a pilot, controlled, feasibility study to evaluate changes in craving, substance use, and quality of life after 6 weeks of a low-risk non-invasive brain stimulation technique, called Synchronized Transcranial Magnetic Stimulation (sTMS), compared to sham, in Veterans with a substance use disorder (SUD). An important focus of this application will be evaluating the acceptability, tolerability, and safety of sTMS in this population. To the investigators knowledge, sTMS has never been used for SUDs, and holds considerable promise as a future treatment option for these prevalent disorders. However initial work in the acceptability, tolerability, and safety of this approach must be conducted first. This project is the first step towards the investigators long-term goal, which is to combine non-invasive brain stimulation with individualized psychotherapy or pharmacotherapy to reduce SUD problems and improve quality of life for Veterans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible male and female Veterans
- •between ages 18-70,
- •Veterans who currently meet criteria for SUD, and, if applicable, have stable treatment regimen (i.e., medications and/or therapy) for at least 6 weeks prior to study procedures
- •ongoing medications and psychotherapy will be allowed to continue unchanged during the study
- •for safety, participants must also meet established criteria for MRI exposure, which is implemented as a conservative measure given the novel application of sTMS in this population
排除标准
- •pregnancy/lactation,
- •history of moderate or severe traumatic brain injury,
- •current or prior neurologic disorder or lifetime history of
- •seizure disorder
- •CNS tumors
- •cerebral aneurysm,
- •unstable medical condition,
- •active suicidality as assessed with the Columbia-Suicide Severity Rating Scale
- •primary psychotic disorder.
结局指标
主要结局
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)
时间窗: 6 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire The Q-LES-Q-SF evaluates general activities that are assessed in the longer form of the Q- LES-Q. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment.
substance specific craving
时间窗: 6 weeks
self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges
Social and Occupational Functioning Assessment Scale (SOFAS)
时间窗: 6 weeks
The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.
次要结局
未报告次要终点