- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01072617
Cerebellar rTMS for the Treatment of Schizophrenic Patients
Safety and Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02215
- Beth Israel Deaconess Medical Center
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age between 18-65 years
- Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)
Exclusion Criteria:
- Prior neurosurgical procedures
- Any history of seizure
- Previous head injury
Contraindication to TMS:
- Implanted pacemaker
- Medication pump
- Vagal stimulator
- Deep brain stimulator
- Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
- Signs of increased intracranial pressure
- TENS unit and ventriculo-peritoneal shunt
- Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
- Advanced liver, kidney, cardiac, or pulmonary disease as defined clinically or a terminal medical diagnosis consistent with survival < 1 year
- A history of significant alcohol or drug abuse in the prior six months
- No focal cortical insult can be present, including tumor or vascular malformation
- Patients may not be actively enrolled in a separate intervention study
Patients unable to undergo a brain MR:
a. claustrophobia refractory to anxiolytics ferromagnetic metal in the body such as a prosthetic heart valve, a pacemaker, or a brain aneurysm clip).
- Change in antipsychotic medication during the last 4 weeks
- Any emergency psychiatry department visit during the last 4 weeks
- Been an inpatient in a psychiatry clinic within the last month
- Any other axis I diagnosis
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Safety of rTMS in schizophrenia patients
Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days
|
Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity. Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Adverse Events
Временное ограничение: 3 weeks
|
Adverse event collection at baseline, daily for 5 days during treatment, every other day by phone until the final assessment at week 1 follow up visit.
|
3 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Временное ограничение: Baseline, 5 days (post-treatment), 1 week post treatment
|
Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia.
The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity.
Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment.
The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.
|
Baseline, 5 days (post-treatment), 1 week post treatment
|
|
Positive and Negative Syndrome Scale (PANSS) - Negative Subscale
Временное ограничение: Baseline, 5 days (post-treatment), 1 week post treatment
|
Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia.
The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity.
Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment.
The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.
|
Baseline, 5 days (post-treatment), 1 week post treatment
|
|
Positive and Negative Syndrome Scale (PANSS) - General Subscale
Временное ограничение: Baseline, 5 days (post-treatment), 1 week post treatment
|
Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia.
The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity.
Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment.
The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.
|
Baseline, 5 days (post-treatment), 1 week post treatment
|
Соавторы и исследователи
Следователи
- Главный следователь: Alvaro Pascual-Leone, MD, PhD, Beth Israel Deaconess Medical Center
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2007P000395
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. .