Use of Magnetic Resonance Imaging and Continuous Theta Burst Stimulation for Catatonia in Autism
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Bush Francis catatonia rating scale
研究概览
简要总结
Despite the significant morbidity and mortality associated with catatonia in autism, no diagnostic research has attempted to identify biomarkers for catatonia. This application will use a participant's own individual brain magnetic resonance image to target the primary motor strip with transcranial magnetic stimulation; to determine if hyper-excitability of the brain directly correlates with symptoms of catatonia and social-emotional impairment in autism. Completion of this project would result in the first study to associate hyper-excitability of the brain with catatonia and core features of autism; findings which are likely to have a significant impact on the health and well-being of autistic individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •History of substance abuse/dependence,
- •History of concomitant major medical/neurologic illness
- •History of seizure within one calendar year
- •History of traumatic brain injury
- •Pregnant or currently breastfeeding
- •Are psychiatrically or medically unstable as determined by the investigator clinical evaluation
- •Prescribed medication contraindicated in TMS
- •Have a history of TMS treatment.
- •Are diagnosed with a syndrome which results in ASD symptoms as preliminary research suggests individuals with these diagnoses have differing biomarker responses to TMS.26
- •Children below the age of fifteen will also be excluded because of decreased likelihood of remaining still in the MRI scanner, as well as for scientific reasons surrounding unknown variability for key variables during pubertal onset.
- •MRI scanning also introduces exclusionary criteria for conditions contraindicated to MRI, thus individuals with any bodily metal, history of claustrophobia, or pacemakers will be excluded.
- •Expresses dissenting behaviors as outlined below.
结局指标
主要结局
Bush Francis catatonia rating scale
时间窗: This examination will be performed twice over the study period. The first examination will occur at the initial visit (baseline). The second examination will occur prior to the TMS procedure. There will be no follow up examination after study completion.
A systematic and standardized physical examination to assess for catatonic symptomology. The minimum score is 0, a positive screen is a score is greater than or equal to 2, and the maximum score is 69. A higher score is associated with more significant catatonic symptomology.
The change in motor evoked potentials elicited from transcranial magnetic stimulation
时间窗: Following the application of cTBS, batches of 10 MEPs will be measured every 20 minutes for a total of 120 minutes. ∆MEP amplitude will be calculated at each 20 minute interval.
Three batches of 10 MEPs will be recorded before cTBS and used as a baseline measure of motor evoked potentials.
次要结局
- Cortical silent period duration from transcranial magnetic stimulation(Obtained during TMS procedure)
- Social responsiveness scale, 2nd edition(Administered at the second research visit along with psychological testing. The second research session will include additional baseline testing. This test will be done before the TMS procedure is performed. It will not be repeated.)
研究者
Joshua Ryan Smith, MD
Assistant Professor of Psychiatry and Behavioral Sciences
Vanderbilt University Medical Center