Electroencephalogram (EEG) Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.
详细描述
Veterans and first responders diagnosed with PTSD will be studied to evaluate safety and efficacy of an EEG personalized TMS paradigm. All participants will undergo 2 days of extensive testing prior to eTMS application and 2 days of testing after. Testing will include MRI, OPM, EEG, behavioral tasks, questionnaires, and an EEG sleep study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
eTMS coil will have an 'active' and 'sham' side and the application will look identical to the participant. The technician will not know which side of the coil is which and will additionally be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran or first responder
- •diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above
排除标准
- •Claustrophobia
- •Contraindications to MRI
- •Uncontrolled medical, psychological, or neurological conditions
- •Unable to calculate EEG alpha frequency
- •History of ECT or rTMS
- •History of intracranial lesion or increased intracranial pressure
- •History of stroke
- •History of other neurologic conditions
- •Family history of epilepsy
- •Personal history of epilepsy
- •certain medications
研究组 & 干预措施
eTMS sham
The sham side of a TMS coil will be used to administer a sham dosage of eTMS application.
干预措施: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS) (Device)
eTMS
The active side of a TMS coil will be used to administer eTMS application.
干预措施: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS) (Device)
结局指标
主要结局
Adverse Events
时间窗: Up to 7 weeks
Adverse event reports (or lack-of) will determine device safety
Report of Symptoms
时间窗: Up to 7 weeks
Symptom questionnaire to be completed before and after all study procedures to determine feasibility in this patient population. Various symptoms will be rated on a likert scale from absent to severe.
次要结局
- PCL-5(Up to 7 weeks)
- OPM(1 session 1 week pre treatment and 1 session 1 week post treatment)
- EEG(Up to 7 sessions collected over 7 weeks.)
- fMRI(1 session 1 week pre treatment and 1 session 1 week post treatment)
研究者
Wynn Legon
Assistant Professor
Virginia Polytechnic Institute and State University