NCT07487454尚未招募不适用
Sham-Controlled Rapid-Acting Neuromodulation for Depression
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Montgomery-Åsberg Depression Rating Scale (MADRS)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Able to provide informed consent
- •18-65 years old
- •Meets MDD criteria per the Mini International Neuropsychiatric Interview (MINI)
排除标准
- •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.
研究组 & 干预措施
Active iTBS
Experimental
The active iTBS group will receive 10 hourly intermittent theta burst stimulation (iTBS) sessions per day for 5 consecutive days.
干预措施: intermittent theta burst stimulation (Device)
Sham iTBS
Sham Comparator
Participants assigned to the sham group will receive 10 hourly sham sessions per day for 5 consecutive days.
干预措施: Sham (No Treatment) (Device)
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: Baseline through study completion, 1 year
Change in depressive symptoms (MADRS scores)
次要结局
- Change in large-scale brain network connectivity measured by fMRI(Baseline through study completion, 1 year)
- Change in electroencephalography (EEG) spectral power(Baseline through study completion, 1 year)
- Change in facial and vocal affective expression(Baseline through study completion, 1 year)
研究者
研究点 (1)
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