Studies of Cognition and Behavior Using Sham Accelerated Transcranial Magnetic Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Accelerated sham TMS feasibility
研究概览
简要总结
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:
- Do expectancy and treatment beliefs change during and after an accelerated sham TMS schedule?
- Do these expectations influence mood, reward processing, or craving?
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Able to provide informed consent (and assent if < 18 years)
- •15-25 years old
- •Slight-to-severe symptoms of depression
排除标准
- •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
研究组 & 干预措施
Open label sham
All study participants will receive sham TMS (no active stimulation will be provided).
干预措施: Transcranial Magnetic Stimulation Sham (Device)
结局指标
主要结局
Accelerated sham TMS feasibility
时间窗: From enrollment to end of study at 5 weeks
Proportion of participants who complete the accelerated sham TMS protocol, defined as completion of all scheduled stimulation sessions. Feasibility will be assessed using session attendance logs and protocol completion records.
Change in treatment expectancy and beliefs
时间窗: From enrollment to end of study at 5 weeks
Change in treatment expectancy and beliefs score from baseline to end of study at 5 weeks, as measured by the Credibility/Expectancy Questionnaire (CEQ). Outcomes will be quantified as the difference in total CEQ score between time points. CEQ scores range from 1 to 9 for treatment credibility and expectancy, with higher scores indicating greater perceived credibility/ expectancy.
Change in reward sensitivity
时间窗: From enrollment to end of study at 5 weeks
Change in reward sensitivity will be assessed as the difference in scores from baseline to 5-week follow-up on validated self-report measures, including the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), the Snaith-Hamilton Pleasure Scale (SHAPS), and the Temporal Experience of Pleasure Scale (TEPS). SPSRQ scores range from 0-24 for each subscale, TEPS scores range from 18-108, and SHAPS scores range from 14-56, with higher scores indicating greater sensitivity to reward/punishment, pleasure capacity, and anhedonia, respectively.
Change in craving and engagement
时间窗: From enrollment to end of study at 5 weeks
Changes in cravings and engagement with reinforcing stimuli will be assessed as the difference in scores from baseline to 5-week follow-up on various self-report measures and tasks. Craving will be assessed using a behavioral craving task, with outcomes quantified as change in task-derived craving ratings or performance metrics from baseline to follow-up. Substance use will additionally be assessed as change in drug use frequency and quantity over the study period.
次要结局
- Changes in depressive symptoms(From enrollment to end of study at 5 weeks)
- Changes in mania symptoms(From enrollment to end of study at 5 weeks)
- Changes in suicidality(From enrollment to end of study at 5 weeks)
- Change in quality of life and functioning(From enrollment to end of study at 5 weeks)
研究者
Maitri Khanna
Co-Principal Investigator
University of California, Davis