Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device (LFMS)
12 апреля 2016 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
107
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Massachusetts
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Belmont, Massachusetts, Соединенные Штаты, 02478
- McLean Hospital
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 70 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Фальшивый компаратор: 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.
Другие имена:
|
|
Активный компаратор: 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.
Другие имена:
|
|
Фальшивый компаратор: 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.
Другие имена:
|
|
Активный компаратор: 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.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression
Временное ограничение: 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.
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Once just before and once just after treatment
|
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Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Michael Rohan, PhD, McLean Hospital
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 ноября 2007 г.
Первичное завершение (Действительный)
1 марта 2011 г.
Завершение исследования (Действительный)
1 марта 2013 г.
Даты регистрации исследования
Первый отправленный
18 декабря 2007 г.
Впервые представлено, что соответствует критериям контроля качества
18 декабря 2007 г.
Первый опубликованный (Оценивать)
21 декабря 2007 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
16 мая 2016 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
12 апреля 2016 г.
Последняя проверка
1 апреля 2016 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2006-P-001655
- Stanley Grant 07TGS-1045 (Другой номер гранта/финансирования: Stanley Grant 07TGS-1045)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Low Field Magnetic Stimulation Device
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University of CopenhagenЗавершенный