Sham-Controlled Rapid-Acting Neuromodulation for Depression

Обзор

The goal of this study is to learn whether 5 days of accelerated intermittent theta burst stimulation (iTBS), a rapid form of transcranial magnetic stimulation (TMS), which is a non-invasive procedure that uses magnetic fields to stimulate brain activity, works to treat depression in adults. The main questions it aims to answer are: * Does accelerated iTBS reduce depressive symptoms compared to sham (placebo) stimulation? * Are there measurable brain, biological, and digitally measured emotion changes associated with treatment response? Participants will: * Be randomly assigned to receive either active iTBS or sham stimulation * Receive 10 stimulation sessions per day for 5 consecutive days (total of 50 sessions) * Complete MRI brain scans and EEG recordings before and after treatment * Provide blood and saliva samples to measure biological markers * Complete depression rating scales and questionnaires at baseline, during treatment, and at follow-up visits * Use a secure mobile app to record brief facial and vocal samples during the 5-day treatment and at follow-up visits * Return for follow-up visits at 1 week and at 1, 3, 6, and 12 months after treatment

Вмешательства

• Устройство intermittent theta burst stimulation
  The TMS protocol involves delivering sessions of intermittent theta burst stimulation (iTBS) of 60 cycles of 10 bursts of three pulses at 50 Hz delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. Stimulation sessions will be delivered hourly. Ten sessions will be applied per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses in total). Stimulation will be delivered at 90% resting motor threshold (rMT). For safety, stimulation will never be delivered above 120% rM
• Устройство Sham (No Treatment)
  Participants assigned to the sham group will receive treatment using a sham TMS coil. This coil looks and sounds similar to the active coil but does not deliver magnetic pulses to the brain.

Первичные конечные точки

• Montgomery-Åsberg Depression Rating Scale (MADRS) [Срок оценки: Baseline through study completion, 1 year]

Вторичные конечные точки (3)

• Change in large-scale brain network connectivity measured by fMRI [Срок оценки: Baseline through study completion, 1 year]
• Change in electroencephalography (EEG) spectral power [Срок оценки: Baseline through study completion, 1 year]
• Change in facial and vocal affective expression [Срок оценки: Baseline through study completion, 1 year]

Критерии участия

Критерии включения

• English speaking
• Able to provide informed consent
• 18-65 years old
• Meets MDD criteria per the Mini International Neuropsychiatric Interview (MINI)

Критерии исключения

• Unable to consent (due to medical condition, acute psychosis, substance use, etc)
• Use of benzodiazepines or medications that would interfere with TMS treatment as per PI discretion
• Active substance use or severe substance use that in the opinion of the PI would interfere with study participation
• Untreated, active psychosis
• Female patient who is breastfeeding, pregnant or who is planning a pregnancy during the study
• Contraindications to receiving TMS and/or MRI as determined by screening questionnaires
• 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UC Davis Medical Center — Sacramento

Идентификаторы

NCT: NCT07487454 · 2398605

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗