Low Field Magnetic Stimulation: Open Label Study.
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in daily mood after LFMS treatment using the Beck Depression Inventory (BDI)
研究概览
简要总结
To assess the effects of daily LFMS treatments for those suffering from affective or anxiety symptoms. We hypothesize a reduction in affective and or anxiety symptoms after active treatment over the period of one week, with improvement through the following week.
详细描述
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain. 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 (< 100x) than those used in ECT and rTMS.
LFMS was discovered at McLean Hospital and has thus far been studied as an experimental antidepressant treatment at McLean Hospital. LFMS is also being studied at Massachusetts General Hospital and 5 other hospitals in an NIH sponsored trial (RAPID) as well as in studies at Cornell-Weill School of Medicine. The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an interaction between the electromagnetic fields and neurons in cortical regions, brought about by low level electrical stimulation applied with particular timing.
The current study proposes to assess the effects of daily LFMS treatments in participants suffering from affective disorders and/or anxiety. This is an open-label study. All subjects will receive active LFMS treatments. Potential subjects will be referred to the study by their clinicians and will be pre-screened by phone.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be accepted into the study upon written referral by a McLean clinician or outside psychiatrist.
- •Subjects will be men or women over the age of
- •Subjects must have failed at least one FDA approved treatment before enrolling in this study.
- •Subjects must be capable of providing informed consent.
- •Subjects must have either a Hamilton Depression Rating Scale (HDRS) score > 14 indicating moderate depression or Hamilton Anxiety Rating Scale (HARS) score > 18 indicating moderate anxiety.
排除标准
- •Dangerous or active suicidal ideation.
- •Pregnant or planning on becoming pregnant.
- •Recent history (within 3 days) of ECT or TMS treatment.
- •Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no history of dependence in last year, no drug use within last month, other than marijuana use).
- •Current psychosis.
- •Contraindications for MRI: Presence of a pacemaker, neurostimulator, or metal in head or neck.
- •"Do Not Resuscitate" order in place (to avoid risk in the case of non-study-related accidents).
结局指标
主要结局
Changes in daily mood after LFMS treatment using the Beck Depression Inventory (BDI)
时间窗: 24 hrs
Daily change in the BDI before and after each LFMS treatment
Change in mood after 5 days of LFMS treatment using the Hamilton Depression Rating Scale (HDRS)
时间窗: 5 days
Change in HDRS from before the first treatment to after the 5th (final) treatment
次要结局
未报告次要终点
研究者
Michael Rohan
Imaging Physicist
Mclean Hospital