NCT04316338撤回不适用
Intermittent Theta-Burst Stimulation to Target Irritability in Adults With ASD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Aberrant Behavior Checklist-irritability subscale (ABC-I)
研究概览
简要总结
This study aims to demonstrate the feasibility, tolerability, safety and preliminary efficacy of 6 weeks of fMRI-guided iTBS delivered to personalized regions of the prefrontal cortex (PFC) in adults with ASD in reducing irritability in adults with ASD.
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
- 22 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ASD or Asperger's based on DSM-5 criteria as confirmed by a qualified clinician (including Dr. Fung), and if necessary the administration of Autism Diagnostic Interview-Revised (ADI-R) and/or Autism Diagnostic Observation Schedule-Generic (ADOS-G)
- •Adults who are physically healthy.
- •No significant current psychosocial stressors per history.
- •Full scale IQ >
- •ABC-I score of 18 or greater.
- •if the participant is taking medication, they must be stable on this medication regiment for at least 4 weeks prior to baseline and agree to stay on these medications for the duration of the trial
排除标准
- •(f) Pre-term birth (<34 weeks' gestation) (g) Low birth weight (<2000 g). (h) DSM-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or schizophrenia.
- •(i) Current use of benzodiazepines. (j) Use of other medications that modulate the GABA(A) receptor within 4 weeks of scanning (8 weeks for fluoxetine).
- •(k) History of alcoholism or substance abuse. (l) Active medical problems such as unstable seizures, congenital heart disease, endocrine disorders.
- •(m) Significant sensory impairments such as blindness or deafness. (n) Contraindication for MRI. (o) Pregnancy. (p) evidence of genetic syndrome.
结局指标
主要结局
Aberrant Behavior Checklist-irritability subscale (ABC-I)
时间窗: Change across time: Baseline minus immediately after final treatment
A parent/caregiver/clinician completed checklist (58-item) with an irritability subscale (15-item). Each item has a maximum score of 3, meaning that the irritability subscale has a maximum score of 45 and minimum score of 0. Higher scores indicate higher levels of irritability.
次要结局
- Self-injury questionnaire (SIQ)(Baseline, immediately after treatment, one month after treatment.)
- THE MODIFIED OVERT AGGRESSION SCALE (MOAS)(Baseline, immediately after treatment, one month after treatment.)
- Difficulties in Emotion Regulation Scale(Baseline, immediately after treatment, one month after treatment.)
- Montgomery-Åsberg Depression Rating Scale (MADRS)(Baseline, immediately after treatment, one month after treatment.)
- Repetitive Behavior Scale-Revised (RBS-R)(Baseline, immediately after treatment, one month after treatment.)
- Functional connectivity between areas involved in negative emotion regulation(Baseline, immediately after treatment, one month after treatment.)
- EEG recordings(Baseline, immediately after treatment, one month after treatment.)
- Aberrant Behavior Checklist-irritability subscale (ABC-I)(Change across time: Baseline minus one month after treatment)
- Irritability Questionnaire(Baseline, every week of treatment (1-6), immediately after treatment, one month after treatment.)
- The Adult Autism Quotient (AQ)(Baseline, immediately after treatment, one month after treatment.)
- Magnetic resonance spectroscopy (MRS)(Baseline, immediately after treatment, one month after treatment.)
研究者
Lawrence Fung
Assistant Professor
Stanford University
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