Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) in Subjects With Bipolar Depression
研究概览
简要总结
This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some of the symptoms of depression in bipolar disorder or major depression.
详细描述
This study involves a screening visit with the study physician and a treatment visit. Participants will be asked to complete several questionnaires about their mood during both visits. The treatment visit will involve use of the LFMS device. Participants will place the top of their head inside the device for approximately 20 minutes. Participants will receive either the actual treatment or a sham treatment and will not know which they receive. This device produces weak electromagnetic fields. There is no discomfort or even sensation caused by the device. The device has been declared to be a "non-significant risk device" by the FDA, and there are no known risks associated with its use.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major Depressive Disorder or Bipolar Disorder; must be currently depressed
- •May be medicated or unmedicated
排除标准
- •Contraindication for MRI due to metal in eyes/head
- •Claustrophobia.
- •Inability to lie flat.
- •History of brain injury.
- •Current drug use/abuse/dependence
- •History of polysubstance use
研究组 & 干预措施
Sham (inactive) Treatment BPD
20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
干预措施: Low Field Magnetic Stimulation Device (Device)
Active LFMS treatment in BPD
20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
干预措施: Low Field Magnetic Stimulation Device (Device)
Sham LFMS Comparator: in MD
20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
干预措施: Low Field Magnetic Stimulation Device (Device)
Experimental LFMS: in MD
20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
干预措施: Low Field Magnetic Stimulation Device (Device)
结局指标
主要结局
Visual Analog Scale (VAS) in Subjects With Bipolar Depression
时间窗: Once just before and once just after treatment
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder
时间窗: Once just before and once just after treatment
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression
时间窗: Once just before and once just after treatment
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder
时间窗: Once just before and once just after treatment
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
次要结局
- Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.(Once just before and once just after treatment)
- Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.(Once just before and once just after treatment)
- Visual Analog Scale (VAS): Combined Diagnostic Groups.(Once just before and once just after treatment)
- Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.(once pre and once post LFMS treatment)
- Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression(once pre and once post LFMS treatment)
- Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.(Once just before and once just after treatment)
- Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder(Once just before and once just after treatment)
- Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder(once pre and once post LFMS treatment)
研究者
Michael Rohan
Imaging Physicist
Mclean Hospital