Mechanistic Circuit Markers of Transcranial Magnetic Stimulation Outcomes in Pharmacoresistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Go-NoGo elicited neural circuit function
研究概览
简要总结
This study is currently recruiting Veterans only. The objective of this observational study is to test whether neuroimaging biomarkers of repetitive transcranial magnetic stimulation (TMS) can be prospectively replicated in a large ecologically valid sample. We focus on cognitive network connectivity as a predictive biomarker of the clinical effect of TMS, and as a response biomarker of change with TMS. We address this objective through a pragmatic approach in which we recruit patients undergoing routine clinical care and program evaluation in a Veterans Administration multi-site clinical TMS program.
详细描述
Although repetitive transcranial magnetic stimulation (TMS) is becoming a gold standard treatment for pharmacoresistant depression, we lack neural target biomarkers for identifying who is most likely to respond to TMS and why. To address this gap in knowledge this observational study evaluates neural targets defined by activation and functional connectivity of the dorsolateral prefrontal cortex-anchored cognitive control circuit, regions of the default mode network and attention circuit, and interactions with the subgenual anterior cingulate.
The study evaluates whether these targets and interactions between them change in a dose-dependent manner, whether changes in these neural targets correspond to changes in cognitive behavioral performance, and whether baseline and early change in neural target and cognitive behavioral performance predict subsequent symptom severity, suicidality, and quality of life outcomes.
This study is designed as a pragmatic, mechanistic observational trial partnering with the National Clinical TMS Program of the Veteran's Health Administration.
All veterans will receive a clinical course of TMS as part of their routine care. Those who agree to enrollment in the observational study will be assessed at 'baseline' prior to commencement of their TMS treatment, 'first week' after initiation of TMS (targeting five sessions) and 'post-treatment' at the completion of TMS (targeting 30 sessions).
Veterans will be assessed using functional magnetic resonance imaging (fMRI), a cognitive behavioral performance battery, and established questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 years and older
- •Meets Diagnostic and Statistical Manual edition 5 (DSM-5) criteria for Major Depressive Disorder (MDD) (as documented by the treating physician)
- •Meet study criteria for pharmacoresistance in accordance with the Clinical transcranial magnetic stimulation (TMS) Program (i.e. failed at least one antidepressant in the current episode)
- •Ability to obtain a motor threshold (MT) prior to the start of treatment
- •Stable medical conditions and ability to maintain stability on current medication regimen for the duration of treatment
- •Ability to participate in a daily treatment regimen
- •Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments
排除标准
- •History of seizure disorder
- •Structural or neurologic abnormalities present or in close proximity to the treatment site
- •History of brain surgery
- •Pacemaker or medical infusion device (unless magnetic resonance imaging compatible)
- •History of traumatic brain injury within 60 days of the start of treatment
- •Severe or uncontrolled alcohol or substance use disorders
- •Active withdrawal from alcohol or substances
- •Implanted device in the head
- •Metal in the head
- •Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments, or unable and/or unlikely to follow the study protocols
- •Lifetime history of bipolar I disorder
- •Inability to speak, read or understand English
- •Plans to move out of the area during the study period
- •Clinician and/or Investigator discretion for clinical safety or protocol adherence
结局指标
主要结局
Go-NoGo elicited neural circuit function
时间窗: Up to 8 weeks
Activation and connectivity assessed using functional magnetic resonance imaging during a GoNoGo task
N-Back elicited neural circuit function
时间窗: Up to 8 weeks
Activation and connectivity assessed using functional magnetic resonance imaging during an N-Back task
Resting state neural circuit function
时间窗: Up to 8 weeks
connectivity assessed using functional magnetic resonance imaging during a resting condition
Go-NoGo elicited neural circuit function
时间窗: Baseline
Activation and connectivity assessed using functional magnetic resonance imaging during a GoNoGo task
Go-NoGo elicited neural circuit function
时间窗: Up to 2 weeks
Activation and connectivity assessed using functional magnetic resonance imaging during a GoNoGo task
N-Back elicited neural circuit function
时间窗: Baseline
Activation and connectivity assessed using functional magnetic resonance imaging during an N-Back task
N-Back elicited neural circuit function
时间窗: Up to 2 weeks
Activation and connectivity assessed using functional magnetic resonance imaging during an N-Back task
Resting state neural circuit function
时间窗: Baseline
connectivity assessed using functional magnetic resonance imaging during a resting condition
Resting state neural circuit function
时间窗: Up to 2 weeks
connectivity assessed using functional magnetic resonance imaging during a resting condition
次要结局
- Continuous Performance Test(Up to 8 weeks)
- Daily function related to quality of life(Up to 8 weeks)
- Symbol Digit Coding Test(Up to 8 weeks)
- Suicidal ideation(Up to 8 weeks)
- Stroop Test(Up to 8 weeks)
- Depressive Symptoms(Up to 8 weeks)
- Shifting Attention Test(Up to 8 weeks)
- Symbol Digit Coding Test(Baseline)
- Symbol Digit Coding Test(Up to 2 weeks)
- Stroop Test(Baseline)
- Stroop Test(Up to 2 weeks)
- Shifting Attention Test(Baseline)
- Shifting Attention Test(Up to 2 weeks)
- Continuous Performance Test(Baseline)
- Continuous Performance Test(Up to 2 weeks)
- Depressive Symptoms(Baseline)
- Depressive Symptoms(Up to 2 weeks)
- Daily function related to quality of life(Baseline)
- Daily function related to quality of life(Up to 2 weeks)
- Suicidal ideation(Baseline)
- Suicidal ideation(Up to 2 weeks)
研究者
Leanne Williams
Professor
Stanford University