Transcranial Magnetic Stimulation in Veterans With PTSD: A Pilot Study to Examine Mechanism of Effect
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Frequency and intensity of PTSD symptoms as assessed by the CAPS-5
研究概览
简要总结
With this research investigators hope to begin to understand how rTMS can improve posttraumatic stress disorder (PTSD) symptoms. TMS improves PTSD through two interrelated mechanisms: change in brain limbic system function and change in systemic inflammatory activation. Participants who decide to join this study, will receive ten rTMS treatments. All participants will undergo a 40-minute rTMS procedure with a member of the study team 10 times over 2-4 weeks. Participants will undergo fMRI scans of the head in order to help researchers better understand potential effects of rTMS on brain activity. In addition, participants will be asked to give two breath and blood samples to look for signs of general inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 19 and 70
- •Eligible for VA healthcare
- •Moderate to severe PTSD as determined by a total score of at least 25 on the CAPS within 7 days of randomization.
- •Agree to have CAPS audio recorded.
- •Ability to obtain a Motor Threshold using the TMS device during screening.
- •If female with childbearing potential, use of acceptable method of birth control (i.e., use of contraceptives, abstinence).
- •Able to read, understand, and sign the informed consent document.
排除标准
- •Pregnant or lactating woman.
- •MRI is contraindicated
- •Current use of clozapine (any dose) or bupropion (more than 300mg per day).
- •Cardiac pacemaker or implantable defibrillator.
- •Presence of any metal object in the head, including cochlear implants, but excluding dental work in the mouth.
- •Significant central nervous system disorder (stroke, brain mass, epilepsy).
- •Seizure in past one year.
- •Current psychosis or mania.
- •Significant suicidal ideation.
- •Unstable medical conditions.
- •Current alcohol or substance use disorder (except nicotine) that interferes with the patient's ability to participate.
- •CPT or PE for PTSD in the past 2 months.
- •Changes in Fluoxetine, Paroxetine, Sertraline, or Venlafaxine in the past 2 months.
- •Color blind
- •Currently participating in other research studies.
- •Aneurysm Clip
- •Ocular foreign body (e.g., metal shavings)
- •Any implanted device (pumps, infusion devices, etc.)
- •Shrapnel injuries or metal fragments
研究组 & 干预措施
Participants receiving open label trial of TMS
干预措施: Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Frequency and intensity of PTSD symptoms as assessed by the CAPS-5
时间窗: From enrollment to the end of treatment at 3 months
The CAPS is a clinician-administered scale of PTSD symptoms, which queries the frequency and intensity of symptoms of PTSD
20 item self-report of PTSD symptoms assessed by PCL-5
时间窗: From enrollment to the end of treatment at 3 months
It asks participants to rate the severity of each of the 20 symptoms of PTSD in DSM-5
次要结局
- A quick self-reported and self administered inventory of depressive symptoms (QIDS-16-SR)(From the baseline to the end of the study at 3 months)
研究者
Bradley Watts
Staff Psychiatrist
White River Junction Veterans Affairs Medical Center