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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
107
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Massachusetts
-
Belmont、Massachusetts、アメリカ、02478
- McLean Hospital
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
偽コンパレータ：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.
他の名前：
|
|
アクティブコンパレータ：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.
他の名前：
|
|
偽コンパレータ：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.
他の名前：
|
|
アクティブコンパレータ：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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Michael Rohan, PhD、McLean Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2007年11月1日
一次修了 (実際)
2011年3月1日
研究の完了 (実際)
2013年3月1日
試験登録日
最初に提出
2007年12月18日
QC基準を満たした最初の提出物
2007年12月18日
最初の投稿 (見積もり)
2007年12月21日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年5月16日
QC基準を満たした最後の更新が送信されました
2016年4月12日
最終確認日
2016年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。