Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device (LFMS)
2016年4月12日 更新者：Michael Rohan、Mclean Hospital
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
107
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
-
Belmont、Massachusetts、美国、02478
- McLean Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosis of Major Depressive Disorder or Bipolar Disorder; must be currently depressed
- May be medicated or unmedicated
Exclusion Criteria:
- Contraindication for MRI due to metal in eyes/head
- Claustrophobia.
- Inability to lie flat.
- History of brain injury.
- Pregnant
- Current drug use/abuse/dependence
- History of polysubstance use
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
假比较器：Sham (inactive) Treatment BPD
20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
|
The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches.
It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m.
Subjects will receive one 20 minute treatment.
其他名称：
|
|
有源比较器：Active LFMS treatment in BPD
20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
|
The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches.
It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m.
Subjects will receive one 20 minute treatment.
其他名称：
|
|
假比较器：Sham LFMS Comparator: in MD
20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
|
The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches.
It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m.
Subjects will receive one 20 minute treatment.
其他名称：
|
|
有源比较器：Experimental LFMS: in MD
20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
|
The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches.
It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m.
Subjects will receive one 20 minute treatment.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression
大体时间：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.
|
Once just before and once just after treatment
|
|
Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder
大体时间：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.
|
Once just before and once just after treatment
|
|
Visual Analog Scale (VAS) in Subjects With Bipolar Depression
大体时间：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.
|
Once just before and once just after treatment
|
|
Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder
大体时间：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.
|
Once just before and once just after treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.
大体时间：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.
|
Once just before and once just after treatment
|
|
Visual Analog Scale (VAS): Combined Diagnostic Groups.
大体时间：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.
|
Once just before and once just after treatment
|
|
Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.
大体时间：Once just before and once just after treatment
|
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely.
Positive and Negative scores are calculated and reported separately and range from 10-50.
Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
|
Once just before and once just after treatment
|
|
Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.
大体时间：once pre and once post LFMS treatment
|
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely.
Positive and Negative scores are calculated and reported separately and range from 10-50.
Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
|
once pre and once post LFMS treatment
|
|
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.
大体时间：Once just before and once just after treatment
|
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely.
Positive and Negative scores are calculated and reported separately and range from 10-50.
Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
|
Once just before and once just after treatment
|
|
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder
大体时间：Once just before and once just after treatment
|
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely.
Positive and Negative scores are calculated and reported separately and range from 10-50.
Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
|
Once just before and once just after treatment
|
|
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression
大体时间：once pre and once post LFMS treatment
|
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely.
Positive and Negative scores are calculated and reported separately and range from 10-50.
Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
|
once pre and once post LFMS treatment
|
|
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder
大体时间：once pre and once post LFMS treatment
|
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely.
Positive and Negative scores are calculated and reported separately and range from 10-50.
Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
|
once pre and once post LFMS treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michael Rohan, PhD、McLean Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Carlezon WA Jr, Rohan ML, Mague SD, Meloni EG, Parsegian A, Cayetano K, Tomasiewicz HC, Rouse ED, Cohen BM, Renshaw PF. Antidepressant-like effects of cranial stimulation within a low-energy magnetic field in rats. Biol Psychiatry. 2005 Mar 15;57(6):571-6. doi: 10.1016/j.biopsych.2004.12.011.
- Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. doi: 10.1176/appi.ajp.161.1.93.
- Rohan ML, Yamamoto RT, Ravichandran CT, Cayetano KR, Morales OG, Olson DP, Vitaliano G, Paul SM, Cohen BM. Rapid mood-elevating effects of low field magnetic stimulation in depression. Biol Psychiatry. 2014 Aug 1;76(3):186-93. doi: 10.1016/j.biopsych.2013.10.024. Epub 2013 Nov 12.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年11月1日
初级完成 (实际的)
2011年3月1日
研究完成 (实际的)
2013年3月1日
研究注册日期
首次提交
2007年12月18日
首先提交符合 QC 标准的
2007年12月18日
首次发布 (估计)
2007年12月21日
研究记录更新
最后更新发布 (估计)
2016年5月16日
上次提交的符合 QC 标准的更新
2016年4月12日
最后验证
2016年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.