A Pilot Study to Evaluate the Efficacy of EEG/ECG-guided Magnetic Resonant Therapy (MeRT) in War Veterans With Posttraumatic Stress Disorder (PTSD) at Tinker and MacDill Air Force Bases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- The outcome will be measured by PTSD checklist -- military version (PCL-M) scoring criteria for PTSD. The outcome is measured additionally by Cognitive and Physical Functioning Questionnaire (CPFQ) for cognitive function improvement among the subjects.
研究概览
简要总结
After 13 years of war, PTSD has become pervasive in service members. Traditionally it is evaluated by PTSD Checklist Military Version (PCL-M) and treated with cognitive processing therapy, prolonged exposure therapy and medication management with limited success. Repetitive Transcranial Magnetic Stimulation (TMS) has shown efficacy for improving individual cognitive function in the past decades, both in healthy population and in patients with depression. TMS has been approved by the FDA in treatment of major depressive disorder and migraine headaches. Magnetic EEG guided Resonant Treatment (MeRT) is a form of individualized TMS based on member's EEG/ECG input. Investigators propose to use MeRT to treat veterans with war-related PTSD, a syndrome that includes depressive and anxious symptoms; it is likely that MeRT (namely TMS) will be beneficial and comparable to or better than the current FDA approved methods for treating 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have diagnosis of combat-related PTSD by DSM-V criteria, diagnosed via clinical interview by psychologist or psychiatrist (note: combat pilots of remotely piloted aircraft are included)
- •PCL-M score > 45
- •Age between 18 and 55 years (at day of informed consent)
- •Willing and able to adhere to the treatment schedule and all required study visits.
- •Must be clinically stable for at least 30 days on or off any PTSD medication before the trial treatment
排除标准
- •Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
- •History of open skull traumatic brain injury
- •History of clinically significant seizure disorder
- •Individuals with a clinically defined neurological disorder including, but not limited to:
- •Any condition likely to be associated with increased intracranial pressure
- •Space occupying brain lesion
- •History of cerebrovascular accident
- •Cerebral aneurysm
- •Abnormalities that indicate risk of seizure, i.e., focal or general slowing or spikes during EEG recording
- •Any type of rTMS treatment within 3 months prior to the screening visit
- •Currently under antipsychotic medication treatment
- •Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed
- •Clinically significant abnormality or clinically significant unstable medical condition that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results
- •Clinically significant medical illness, including any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning
- •Any condition which in the judgment of the investigator would prevent the subject from completion of the study
- •Inability to acquire a clinically satisfactory EEG/ECG on a routine basis
- •Grossly abnormal electrolyte or cell blood count panels suggestive of other pathology at study initiation
- •Pregnant or breastfeeding women
结局指标
主要结局
The outcome will be measured by PTSD checklist -- military version (PCL-M) scoring criteria for PTSD. The outcome is measured additionally by Cognitive and Physical Functioning Questionnaire (CPFQ) for cognitive function improvement among the subjects.
时间窗: At the end of week of 4 and 8.
The change of PCL-M and CPFQ scores from baseline and at weeks of 4 and 8 are assessed.
次要结局
未报告次要终点
研究者
Jianzhong Zhang
Chief, Aeromedical Services
72nd Medical Group, Tinker Air Force Base