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Идёт набор NCT06105164

Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans

Без фазы С лечением Appetitive Behavior Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Repetitive Transcranial Magnetic Stimulation (rTMS), Sham repetitive Transcranial Magnetic Stimulation (rTMS).
Кому может быть актуально
Состояния в реестре: Appetitive Behavior, Obesity. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study satiety in healthy individuals. TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study, the investigators will be stimulating the brain to learn more about the role of the cerebellum in satiety.

Подробное описание

The purpose of this study is to conduct a circuit manipulation experiment to test the hypothesis that targeting the cerebellum can alter activity in response to food cues to advance the understanding of the involvement of the cerebellar-striatal circuit in feeding behavior.

Participants will undergo an initial screening session to complete informed consent and undergo baseline assessments including physical activity and food craving. Participants will additionally undergo an MRI scan that includes structural and resting-state functional magnetic resonance imaging (rsfMRI). These rsfMRI imagines will be used to isolate individual resting state networks for targeting of rTMS modulation.

Participants will then complete two separate testing sessions involving MRI imaging and food intake assessments before and after rTMS. One visit will involve consumption of a filling meal; the other visit will be completed following an overnight fast.

Вмешательства

  • Устройство Repetitive Transcranial Magnetic Stimulation (rTMS)
    rTMS is a technique of TMS that allows for selective external manipulation of neural activity in a non-invasive manner. During rTMS a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field, which in turn induces electrical current in neurons and allows for modulation of neural circuitry. Intermittent theta burst stimulation (iTBS) consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 60
  • Устройство Sham repetitive Transcranial Magnetic Stimulation (rTMS)
    rTMS is a technique of TMS that allows for selective external manipulation of neural activity in a non-invasive manner. During rTMS a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field, which in turn induces electrical current in neurons and allows for modulation of neural circuitry. Intermittent theta burst stimulation (iTBS) consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 60

Первичные конечные точки

  • Change in BOLD response in the cerebellum [Срок оценки: 30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)]
  • Change in BOLD response in the ventral striatum [Срок оценки: 30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)]
  • Change in food reward valuation [Срок оценки: up to 60 minutes pre-TMS and up to 60 minutes post-TMS, at each of two main study visits (fed, fasted)]
  • Ad libitum snack food intake [Срок оценки: baseline, up to 60 minutes post-TMS at each of two main study visits (fed, fasted)]

Критерии участия

Критерии включения

  • Healthy individuals aged 18 to 65
  • BMI of 20-35.0 kg/m2
  • Normal or corrected-to-normal vision
  • Good general health
  • Ability to understand and willingness to sign written informed consent document

Критерии исключения

  • Current and/or past medical conditions
  • Current and/or past eating disorder
  • On a restricted diet and/or taking weight loss medication(s)
  • History of bariatric surgery
  • Weight fluctuation >3% in past 3 months
  • Recent history of illicit recreational drug abuse
  • Current nicotine use
  • Intellectual disability
  • Conditions that might result in increased risks of side effects or complications from TMS or MRI

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Другое

Центры проведения

США · 2 центра
  • McLean Hospital — Belmont
  • Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT06105164 · 2023P002811

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗