Mini Theta Burst TMS to Promote Brain Plasticity Indexed by fMRI in MDD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen
研究概览
简要总结
This is not a treatment study.
In this study, the researchers are primarily interested in examining whether functional MRI (fMRI)-guided transcranial magnetic stimulation (TMS) may be more effective than traditional TMS methods at temporarily influencing neural circuit communication. The investigators test this by combining TMS and fMRI technologies to probe and modulate brain activity.
If the novel fMRI-guided TMS stimulation used in this study is more effective than traditional methods, future studies may utilize similar personalized TMS targeting methods to yield even better clinical outcomes.
详细描述
This study will involve a baseline Magnetic Resonance Imaging (MRI) scan, Transcranial Magnetic Stimulation (TMS), and TMS interleaved with functional MRI (fMRI) scans.
After screening, eligible participants will undergo a 1-hour MRI scan, encompassing structural and functional scans to establish TMS stimulation targets for subsequent visits. During the baseline TMS/fMRI session or pre-intervention TMS/fMRI, single pulses of TMS and a short round of repetitive TMS (rTMS) will be administered to the participant's individualized target while functional MRI scans (fMRI) are collected. Following this, participants will commence a short TMS intervention regimen involving daily rTMS over 3 consecutive days. The day after the intervention, participants will undergo another TMS/fMRI session, or the post-intervention TMS/fMRI, to capture potential changes from the 3-day intervention.
Clinical assessments will be conducted at baseline before the first TMS/fMRI session and again after the final TMS/fMRI session to assess symptom changes.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 60 years old, inclusive
- •Right-handed
- •Currently experiencing a major depressive episode (MDD)
- •Capacity to give informed consent and follow study procedures
- •Command of English language to understand/ respond to written and verbal instructions
排除标准
- •MRI contraindications (i.e., metal in body, claustrophobia, etc.)
- •TMS contraindications (i.e., seizure disorder)
- •Diagnosis of exclusionary psychiatric disorder (i.e., schizophrenia, bipolar)
- •Current use of psychiatric medication and unable/ willing to safely withdraw
- •Refusal to abstain from alcohol or drugs for duration of study
- •Medication use that reduces seizure threshold
- •Medication that interferes with blood flow (i.e., opioids, antihypertensive)
- •Known neurological disorder or significant disability that interferes with study procedures
- •Woman who is pregnant or breastfeeding
结局指标
主要结局
Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen
时间窗: 5 days
Change in subgenual anterior cingulate evoked response (fMRI BOLD) at all four timepoints across the two TMS/fMRI scan sessions: pre-intervention and preceding a single round of iTBS in the scanner (pre-tx, pre-iTBS); pre-intervention, following single iTBS in the scanner (pre-tx, post-iTBS); post intervention, preceding iTBS in the scanner (post-tx, pre-iTBS); and post-intervention, post-iTBS in the scanner (post-tx, post-iTBS). Greater negative change is associated with more clinical improvement.
次要结局
- Change in Depression, Anxiety and Stress Scale (DASS-21) Score Pre/Post the 3-Day TMS Intervention Regimen(Up to one week)
研究者
Desmond Oathes
Assistant Professor of Psychiatry
University of Pennsylvania