Low Field Magnetic Stimulation in Mood Disorders in Six Visits
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale (MADRS)score
研究概览
简要总结
To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.
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.
The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an effect on dendritic or synaptic activity in the cortex, brought about by low level electrical stimulation applied with particular timing. This is analogous to the synaptic effects of pharmaceutical antidepressants in providing a "boost" to synapses in certain brain regions.
Previous investigations of LFMS included depressed subjects with bipolar disorder. This study will evaluate the antidepressant effects of multiple LFMS treatments in bipolar disorder and major depressive disorder.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects MUST be significantly depressed, currently.
- •Subjects must not have serious physical illnesses, neurological diseases or dementias.
- •Subjects will meet DSM-IV criteria for Bipolar Disorder Type I or II, Major Depressive Disorder, Post Traumatic Stress Disorder, or Obsessive Compulsive Disorder, and be currently depressed.
- •Subject must have a Ham-D score > 17, YMRS score < 7 (bipolar subjects only), and a MADRS score >
- •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).
- •Mixed mood state or rapid cycling.
- •Presence of a pacemaker, neurostimulator, or metal in head or neck.
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale (MADRS)score
时间窗: at baseline and at week 3
MADRS scores will be compared between the baseline and week 3, one week after the final treatment.
Change in Positive-Negative Affect Scale (PANAS)score
时间窗: at baseline and at one and at week 3
PANAS scores will be compared between the baseline and week 3, one week after the final treatment.
次要结局
- Immediate mood improvement as measured by the difference in post and pre treatment PANAS ratings(at baseline and immediately before and after each treatment, 6 treatments across 2 weeks)
- Change in Positive-Negative Affect Scale (PANAS)score.(at baseline and at one and at week 4)
- Change in Montgomery-Asberg Depression Rating Scale (MADRS)score(at baseline and at week 4)
研究者
Michael Rohan
Imaging Physicist
Mclean Hospital