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Набор по приглашению NCT07467473

Causal Role of Rostromedial Prefrontal Cortex for Positive Savoring in Depression

Без фазы С лечением Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst

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: Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation.
Кому может быть актуально
Состояния в реестре: Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst, Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst, Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is a non-invasive brain stimulation and neuroimaging study that will examine how activity in the medial prefrontal cortex influences reward processing, particularly positive savoring, in individuals with depression. The central question is whether modulating medial prefrontal brain regions using transcranial magnetic stimulation (TMS) alters neural and behavioral responses to rewards. Brain activity will be recorded using both electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) while participants perform reward tasks. The primary objectives are to (1) identify patterns of brain activity linked to impaired reward processing in depression using EEG and fMRI, and (2) determine the causal role of specific prefrontal areas in these processes through targeted TMS. The methods include four sessions over four weeks: a clinical assessment, EEG recording during reward tasks after participants learn/practice positive savoring, an fMRI session, and a TMS session combined with EEG while participants practice positive savoring and perform reward tasks during EEG.

Вмешательства

  • Устройство Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation
    For accelerated intermittent theta burst stimulation (aiTBS), stimulation intensity will be set at 80% resting motor threshold (rMT), a level that has been established to be safe and effective. aiTBS will consist of bursts containing 3 pulses at 50 Hz. Bursts will be delivered at 5 Hz for 2 seconds at 80% of rMT, followed by 8 seconds without stimulation. This pattern will continue for 60 cycles (1800 pulses), for a total elapsed time of 10 minutes. Participants will be randomized to receive aiT

Первичные конечные точки

  • Late Positive Potential during Positive Savoring [Срок оценки: From baseline EEG to post-stimulation EEG approximately 2 weeks apart]
Вторичные конечные точки (1)
  • Positive Affect Ratings on the Positive and Negative Affect Schedule (PANAS) [Срок оценки: From the start to the end of a 3 hour study visit]

Критерии участия

Критерии включения

  • Between the ages of 18 and 65
  • Able to provide informed consent
  • Have normal or corrected vision
  • Right handed
  • Willing to comply with all study procedures and be available for the duration of the study
  • Speak and understand English
  • Not color blind
  • Acceptable suicide risk as determined by less than 5 on the Depression Symptom Index Suicidality Subscale (DSI-SS)
  • A diagnosis of major depressive disorder (current episode) on the Structured Clinical Interview for the DSM-5 (SCID-5)
  • Between the ages of 18 and 65

Критерии исключения

  • ADHD (currently under treatment)
  • Neurological disorders and conditions. Including but not limited to: history of epilepsy, seizures (except childhood febrile seizures), dementia, history of stroke, Parkindon's disease, multiple sclerosis, cerebral aneurysm, brain tumors
  • Medical or neurological illness or treatment for a medical disorder that could interfere with study participation. For example, unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment
  • Prior brain surgery
  • Any brain devices/implants, including cochlear implants and aneurysm clips, cardiac pacemaker, or any other implanted electronic device
  • History of current traumatic brain injury
  • Pregnancy (for females)
  • Claustrophobia
  • DSM-5 diagnosis of present moderate or severe substance use disorder or alcohol use disorder, and past severe substance use disorder or alcohol use disorder, bipolar disorder, or psychotic disorder
  • Based on the use of MRI, additional exclusion criteria are considered. These include participants having ferrous metal in their body, having non-removable jewelry that is ferrous, having tattoos on the face or neck, history of being a metal worker or having an eye injury involving metal
  • Anything that in the opinion of the investigator would place the participant at increased risk or preclude the participant's full compliance with or completion of the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Florida State University — Tallahassee

Идентификаторы

NCT: NCT07467473 · STUDY00006827

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗