A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in anxiety
研究概览
简要总结
The investigators propose to make the first observations of LFMS treating a population of subjects with PTSD. A positive outcome for this study could translate directly into a new treatment modality for symptoms of PTSD in both acute and chronic situations. The investigator's goal is to demonstrate the safety and efficacy of LFMS as a possible aid in the treatment of PTSD.
详细描述
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods. LFMS electromagnetic fields are significantly weaker than those occurring in electroconvulsive therapy (ECT) and repeated transcranial magnetic stimulation (rTMS).
LFMS was discovered at McLean Hospital and has been studied as an experimental antidepressant treatment at McLean. Results from the investigator's single-visit protocol (2006-P-001655) are encouraging, and demonstrate an immediate mood improvement from LFMS in depressed subjects. This indicates that LFMS continues to show potential as a treatment for depression. The profile of clinical response to LFMS that was observed in that study included improvement in symptoms of anxiety. In this current proposal the investigator's will study the effects of LFMS on these symptoms of depression and anxiety that are present in a population with a primary diagnosis of PTSD. The proposed protocol involves three treatments on consecutive days with follow-up ratings one week after the first treatment and follow-up by phone ratings in weeks three and four after the first treatment.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be men or women between the ages of 21-
- •Subjects will meet Diagnostics and Statistical Manual of Mental Disorders (DSM-IV) criteria for Post Traumatic Stress Disorder (PTSD), current.
- •Subject must have a PTSD Check List-5 (PCL-5) score greater than
- •Subjects must be capable of providing informed consent.
- •Subjects must have an established residence and phone.
- •Subjects may be medicated or unmedicated.
排除标准
- •Dangerous or active suicidal ideation.
- •Pregnant or planning on becoming pregnant.
- •Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no major polysubstance abuse history, no history of dependence in last year, no drug use within last month).
- •Significant medical or neurological illness that might pose a risk to study enrollment or interfere with interpretation of study data.
- •Subjects must not have serious physical illnesses, neurological diseases or dementias.
- •Changes in psychiatric medication (e.g. dose or drug) within 6 weeks prior to enrollment.
- •History of an Axis 2 disorder, schizophrenia or schizoaffective disorder.
- •Contraindications for magnetic resonance imaging (MRI): Presence of a pacemaker, neurostimulator, or metal in head or neck.
结局指标
主要结局
Change in anxiety
时间窗: 1 week
Change in anxiety levels as measured by the Hamilton Anxiety Rating Scale in subjects receiving active LFMS treatment relative to sham treatment
Change in depression
时间窗: 1 week
Change in depression as measured by the Montgomery Asberg Depression Rating Scale in subjects receiving active LFMS treatment relative to sham treatment
次要结局
- Improvement in core PTSD symptoms(1 week)
- Daily improvements in short-term measures of anxiety(24 hrs)
- Daily improvements in short-term measures of depression(24 hrs)
研究者
Michael Rohan
Imaging Physicist
Mclean Hospital