- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01861639
Stability of rTMS on Cognition and Brain Networks on Healthy Subjects.
Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Cognition and Brain Networks in Healthy Subjects in 2 Sessions 15 Days Apart
Episodic and working memory processes are the most affected cognitive domains in Alzheimer's Disease (AD) and its early stage, Mild Cognitive Impairment (MCI).
Transcranial Magnetic Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing "virtual and transient lesions", mimicking those observed in MCI. It has proven repeatedly its capacity to interfere with encoding-retrieval memory task. However, to date, only few imaging data exist on the cerebral pathways involved in encoding memory task. Moreover, the stability of TMS effects over time remains to be investigated. If proven to be a stable interfering challenge, TMS could be used to investigate the potential restoring effect of new medication in AD.
The study is the pilot study of a larger clinical trial which aims to prove the utility of rTMS as a potential model for prediction of clinical efficacy using a combination of cognitive and neuroimaging endpoints.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Healthy male subjects aged between 18 and 40 years-old inclusive.
- Education level: at least secondary.
- Right-handed (Edinburgh Handedness Inventory).
- The subjects are in good health on the basis of the medical interview (medical history, symptoms), the physical examination and vital signs.
- No history of psychiatric disorders (assessed by Structured Clinical Interview for DSM IV Disorders (SCID) for Barcelona and by the Mini International Neuropsychiatric Interview (MINI) for Marseille).
- No history of neurological disorders
- No history of concussion (cranial or facial trauma) without or with loss of consciousness.
- Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor...).
- Subject without lesion on MRI.
- Subject without abnormal electrical activities on standard clinical EEG.
- No history of drug or alcohol abuse.
- No smoker or ≤ 5 cg/ day.
- The subject can complete the neuropsychological test battery during the training session.
- Subject without contraindication to MRI.
- The subject is able to read and understand the Information Form and comply with the protocol instructions and restrictions.
- The subject is covered by a social insurance.
- The subject has provided written informed consent.
Exclusion Criteria:
- History or presence of psychiatric illness (Psychiatric interview).
- History or presence of neurologic illness.
- The subject, in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
- The subject participates in another clinical trial or is still being within a washout period of 1 month since last taking of a previous clinical trial, or subjects who have received more than 4500 Euros in the previous 12 months for participating in clinical trials.
- Presence of metallic objects within the body.
- Subjects with pacemaker.
- Claustrophobia.
- Individual and familial history of epileptic seizure.
- Any medication listed (see annexe) in the safety guidelines published by the Safety of TMS Consensus Group (Rossi et al., 2009) will be forbidden.
- Subject with a correct hit rate during the retrieval session of the memory task
Учебный план
Как устроено исследование?
Детали дизайна
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: ineffective rTMS - Active TBS - fMRI
|
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold.
Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC.
Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
Functional MRI data will be acquired during the performance of the memory task.
Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
|
Экспериментальный: Effective rTMS - Active TBS - fMRI
|
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC.
Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
Functional MRI data will be acquired during the performance of the memory task.
Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold.
Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
|
Фальшивый компаратор: ineffective rTMS - Sham TBS - fMRI
|
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold.
Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
Functional MRI data will be acquired during the performance of the memory task.
Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
A Sham stimulation will be applied over the L-DLPFC.
a placebo coil will be used.
|
Фальшивый компаратор: Effective rTMS - Sham TBS - fMRI
|
Functional MRI data will be acquired during the performance of the memory task.
Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold.
Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
A Sham stimulation will be applied over the L-DLPFC.
a placebo coil will be used.
|
Экспериментальный: ineffective rTMS - Active TBS - EEG
|
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold.
Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC.
Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented.
EEG imaging data will be acquired during the memory task.
|
Экспериментальный: Effective rTMS - Active TBS - EEG
|
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC.
Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold.
Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented.
EEG imaging data will be acquired during the memory task.
|
Фальшивый компаратор: ineffective rTMS - Sham TBS - EEG
|
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold.
Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
A Sham stimulation will be applied over the L-DLPFC.
a placebo coil will be used.
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented.
EEG imaging data will be acquired during the memory task.
|
Фальшивый компаратор: Effective rTMS - Sham TBS - EEG
|
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold.
Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
A Sham stimulation will be applied over the L-DLPFC.
a placebo coil will be used.
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented.
EEG imaging data will be acquired during the memory task.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Outputs of the memory task
Временное ограничение: up to Day 15
|
outputs: number of correct answers during the retrieval event-related task (Hit rate) and the rate of false recognition of novel pictures (False Alarms rate).
|
up to Day 15
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
CANTAB task
Временное ограничение: Day 1 and Day 15
|
|
Day 1 and Day 15
|
Gene expression
Временное ограничение: Day 1
|
Interest genes expression will be investigated depending on the impact of TMS on behavioral and functional brain responses.
|
Day 1
|
Imaging
Временное ограничение: Day1 and Day 15
|
Functional MRI (Barcelona): modifications will be highlighted by changes in Blood Oxydation level Dependence (BOLD)signal patterns EEG (Marseille): modifications will be highlighted by changes in EEG markers |
Day1 and Day 15
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Christine Audebert, Cic-Cpcet
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 (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- WP1P003
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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. .
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