NCT02268084已完成不适用
A Randomized Double-Blind Placebo-Controlled Trial to Evaluate Treatment Efficacy of EEG/ECD-Guided Magnetic Resonant Therapy in Combat Veterans With Post-Traumatic Stress Disorder (PTSD).
Wave Neuroscience2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase
研究概览
简要总结
The purpose of this study is to establish the efficacy of Magnetic Resonant Therapy in treating Post Traumatic Stress Disorder in Veterans.
详细描述
This clinical trial is a prospective, randomized, double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of EEG/ECG-guided magnetic resonant therapy (MRT) in combat veterans with Posttraumatic Stress Disorder. A total of 2004 subjects will be treated in two phases: double-blind and open label.
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, Care Provider)
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
- •Willing and able to adhere to the treatment schedule and all required study visits.
- •Any non-Active Duty Military are included.
- •PCL-M > 45
- •Primary diagnosis of Posttraumatic Stress Disorder rendered by the Clinician Administered PTSD Scale (CAPS)
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.
- •EEG abnormalities that indicate risk of seizure, i.e., abnormal focal or general slowing or spikes during the 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.
- •Active Duty Military are excluded.
结局指标
主要结局
Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Double-Blind Phase
时间窗: Baseline (Day 0) and End of Double-Blind Treatment (Week 2)
Mean change in the PCL-M total scores of subjects from baseline to end of the double-blind treatment phase, compared between active and sham groups. The Post-traumatic Stress Disorder Checklist - Military Version (PCL-M) is a 17-item metric for PTSD symptoms, as defined by the DSM-IV. Each symptom is scored on a scale from 1-5; total scores range from 17 (least symptomatic) to 85 (most symptomatic).
次要结局
- Mean (SD) Change in Post-Traumatic Stress Disorder Checklist - Military Version (PCL-M) Scores From Baseline to End of Open-Label Treatment Phase(Baseline (Day 0) and End of Open-Label Treatment (Week 4))
- Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Double-Blind Treatment(Baseline (Day 0) and End of Double-Blind Treatment (Week 2))
- Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Open-Label Treatment(Baseline (Day 0) and End of Open-Label Treatment (Week 4))
- Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Scores From Baseline to End of Treatment(Baseline and End of Double-Blind (Week 2))
- Mean (SD) Change in World Health Organization's Quality of Life Index (WHO-QOL) Domain Score From Baseline to End of Open-Label Treatment(Baseline (Day 0) and End of Open-Label (Week 4))
- Mean (SD) Change in Pittsburgh Sleep Quality Index - Addendum for PTSD (PSQI-A) Score From Baseline to End of Open-Label Treatment(Baseline (Day 0) and End of Open-Label Treatment (Week 4))
- Mean (SD) Change in Hamilton Depression Rating Scale (HAMD-17) Scores From Baseline to End of Double-Blind Treatment(Baseline (Day 0) and End of Double-Blind Treatment (Week 2))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Static Magnetic Therapy for Carpal Tunnel SyndromeCarpal Tunnel SyndromeNCT02609113Wake Forest University Health Sciences22
已完成
3 期
Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon SiteAxial SpondyloarthritisPsoriatic ArthritisEnthesitisNCT02771210Novartis Pharmaceuticals204
已完成
1 期
Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus InfectionOral Herpes SimplexNCT01308424Beech Tree Labs, Inc.171
已完成
4 期
A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDsRheumatoid ArthritisNCT01034397Hoffmann-La Roche54
终止
2 期
A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis BullosaEpidermolysis BullosaNCT00311766RegeneRx Biopharmaceuticals, Inc.30