Cognition and Behavior With Sham Accelerated TMS

Официальное название

Studies of Cognition and Behavior Using Sham Accelerated Transcranial Magnetic Stimulation

Обзор

The goal of this clinical study is to understand how a person's expectations about treatment can influence their mood, motivation, and reactions to everyday rewards. The study includes young people ages 15-25 who will complete a sham (placebo) version of an accelerated transcranial magnetic stimulation (TMS) treatment. No active brain stimulation is given. The main questions this study aims to answer are: 1. Do expectancy and treatment beliefs change during and after an accelerated sham TMS schedule? 2. Do these expectations influence mood, reward processing, or craving? 3. Does a more intensive schedule of sham sessions lead to different expectancy effects than a slower, once-daily schedule? Participants will: * Complete baseline clinical assessments and an MRI session * Undergo five days of accelerated sham TMS (no active brain stimulation is delivered) * Complete post-treatment MRI and follow-up assessments at 1 week and 4 weeks

Вмешательства

• Устройство Transcranial Magnetic Stimulation Sham
  All study participants will receive sham TMS (no active stimulation will be provided).

Первичные конечные точки

• Accelerated sham TMS feasibility [Срок оценки: From enrollment to end of study at 5 weeks]
• Change in treatment expectancy and beliefs [Срок оценки: From enrollment to end of study at 5 weeks]
• Change in reward sensitivity [Срок оценки: From enrollment to end of study at 5 weeks]
• Change in craving and engagement [Срок оценки: From enrollment to end of study at 5 weeks]

Вторичные конечные точки (4)

• Changes in depressive symptoms [Срок оценки: From enrollment to end of study at 5 weeks]
• Changes in mania symptoms [Срок оценки: From enrollment to end of study at 5 weeks]
• Changes in suicidality [Срок оценки: From enrollment to end of study at 5 weeks]
• Change in quality of life and functioning [Срок оценки: From enrollment to end of study at 5 weeks]

Критерии участия

Критерии включения

• English speaking
• Able to provide informed consent (and assent if < 18 years)
• 15-25 years old
• Slight-to-severe symptoms of depression

Критерии исключения

• Past exposure to Transcranial Magnetic Stimulation
• Unable to consent (due to medical condition, psychosis, substance use, etc)
• Acute suicidal crisis or with active medical illness that would interfere with participation
• Contraindications to receiving MRI as determined by screening questionnaires (Contraindications for MRI include metal in the body related to an injury or surgery, for example, surgical clips, metal fragments in the eyes, or piercings that cannot be removed. Subjects with braces or permanent retainers will not be scanned, because the effects on image signal are not well understood and may affect comparability between subjects and scan sites. Participants will be excluded for major neurological problems, such as seizure disorder, traumatic brain injury with loss of consciousness, or sensory problems that may impair task performance, such as blindness.)
• Participation in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• UC Davis Medical Center — Sacramento

Идентификаторы

NCT: NCT07397858 · 2375938

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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