Pilot Testing of Theta-Burst Neuromodulation for Chronic PTSD
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Number of Participants Retained, a Measure of Acceptability of TBS Procedures
研究概览
简要总结
The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with PTSD. Primary outcomes measures include a feasibility of TBS procedures, with secondary outcome measures focusing on changes in PTSD symptom severity and quality of life and social/occupation functioning.
详细描述
The purpose of the proposed study is to evaluate the feasibility of theta burst transcranial magnetic stimulation (TBS) as an adjunct treatment for Veterans with PTSD. This project will result in development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD, which will assess the relationship between change in symptoms and quality of life. It will also lay the foundation for subsequent rehabilitation studies combining neuromodulation and psychotherapy in the longer term.
TBS has several advantages compared to standard repetitive Transcranial Magnetic Stimulation (rTMS), including its ability to deliver large numbers of stimulation pulses in a shorter time period, and a stimulation pattern that may specifically affect key brain regions involved in PTSD. The significance of this research is the development of a novel, non-invasive brain stimulation approach for PTSD recovery. This project will provide the foundation for the development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD to ultimately develop brain stimulation techniques that can be combined with evidence-based psychotherapy, to develop a more powerful, individualized rehabilitation option for Veterans with 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Diagnosis of chronic PTSD according to DSM-5 criteria
- •Veteran (male or female)
- •age between 18-70 years
- •clinically symptomatic despite ongoing stable treatment regimens for at least 6 weeks prior to study procedures
- •capable of independently reading and understanding patient information materials and providing informed consent
排除标准
- •Cardiac pacemaker
- •implanted device (deep brain stimulation) or metal in the brain
- •cervical spinal cord
- •or upper thoracic spinal cord
- •pregnancy/lactation, or planning to become pregnant during the study
- •lifetime history of moderate or severe traumatic brain injury (TBI)
- •current unstable medical conditions
- •current (or past if appropriate) significant neurological disorder, or lifetime history of:
- •seizure disorder
- •primary or secondary CNS tumors
- •cerebral aneurysm
- •primary psychotic disorder
- •bipolar I disorder
- •active moderate/severe substance use disorders (within the last month, excluding nicotine/caffeine
- •active suicidal intent or plan
研究组 & 干预措施
Sham Stimulation
A sham coil is being used to compare against active coil.
干预措施: Sham stimulation (Device)
Active Stimulation
An active coil is being used to compare against sham coil.
干预措施: Theta burst stimulation (Device)
结局指标
主要结局
Number of Participants Retained, a Measure of Acceptability of TBS Procedures
时间窗: 2 weeks
Measurement of TBS acceptability, measured using participant retention rates (all-cause discontinuation)
次要结局
- Change in PTSD Symptom Severity(Baseline and end of double-blind period (2 weeks))
- Change in Quality of Life Due to TBS Treatment(Baseline and end of double-blind period (2 weeks))
- Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment(Baseline and end of double-blind period (2 weeks))