Targeting Fronto-Striatal Neural Circuitry Using Repetitive Transcranial Magnetic Stimulation to Reduce Irritability
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Frontostriatal connectivity
研究概览
简要总结
This pilor study will use repetitive Transcranial Magnetic Stimulation (rTMS) as a noninvasive circuit-based neural modulation to test frontostriatal circuitry as a potential target to reduce irritability.
详细描述
Aim 1: To establish frontostriatal (dACC, dlPFC, striatum) circuitry as the neural circuitry mediating frustration.
Aim 2: To modulate the neural circuitry of frustration and evaluate the neural, behavioral, and affective responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •able to give informed consent in English
- •elevated levels of irritability, defined as scoring ≥5 on the Affective Reactivity Index (ARI)
- •Absence of cognitive impairment. Must have an IQ equivalent of ≥ 70 on the WASI
- •Absence of MRI or TMS contraindications
排除标准
- •History of any neurological disorder that would increase seizure risk from rTMS such as stroke, brain lesions, previous neurosurgery, any history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month.
- •First-degree family history of any neurological disorder with a potentially hereditary basis, including epilepsy or multiple sclerosis.
- •Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes rTMS or MRI administration.
- •Current use of any investigational drug or of anti or pro-convulsive action.
- •Use of benzodiazepines.
- •Lifetime history of schizophrenia, bipolar disorder, mania, autism spectrum disorder, intellectual disability, hypomania, or post-traumatic stress disorder.
- •History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack.
- •Participation in any TMS session less than 2 weeks prior to admission. (No TMS exposure for treatment purposes in the last 6 months.)
- •History or current substance use disorder, excluding cannabis use disorder.
- •Major medical illnesses.
- •An acute risk of hurting themselves or others.
- •Pregnant or lactating women.
- •Participant-reported history of severe claustrophobia.
- •Excessive weight beyond the MRI limit (> 450 lbs)
结局指标
主要结局
Frontostriatal connectivity
时间窗: Day 1-3
Frontostriatal connectivity easured using fMRI during a frustration task. The unit of measure is degrees of functional connectivity.
Grip force (an index of motor activity)
时间窗: Day 1-3
Grip force measured using a dynamometer during a frustration task. The unit of measure is pounds of force.
Self-reported frustration and unhappiness
时间窗: Day 1-3
Self-reported frustration and unhappiness measured using self-rated Likert scales from 1 to 9 during a frustration task. Total score range 1-9 with higher scores indicating more frustration and unhappiness.
次要结局
未报告次要终点