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临床试验/NCT05104697
NCT05104697已完成不适用

TMS for Improving Response Inhibition in Adolescents With OCD

Bradley Hospital2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Change in Response Time on Stop Trials of the Stop Signal Task

研究概览

简要总结

The study will examine whether inhibition of the pre-supplementary motor area (pSMA) using transcranial magnetic stimulation (TMS) normalizes activity in pSMA-connected circuits, improves response inhibition, and reduces compulsions in adolescents with OCD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 13-18 years
  • Presence of OCD, as indicated by score on the Children's Yale-Brown Obsessive-Compulsive Scale
  • Patient and one parent speak English fluently (to ensure comprehension of study measures and instructions
  • Right-handed
  • If taking psychotropic medications, these have been stable for > 6 weeks and are expected to remain stable for the approximately 3-week study protocol
  • If currently in psychotherapy, symptom improvement has plateaued (no improvement in the past 6 weeks and symptoms expected to remain stable for the approximately 3-week study protocol)

排除标准

  • • Medical conditions contraindicated for TMS or EEG, including history of intracranial pathology, increased intracranial pressure, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, possible pregnancy (female of childbearing age not using effective contraception), or any other serious medical condition (note that medical history will be reviewed by a study physician prior to TMS administration)
  • Metal in the head, except mouth (e.g., cochlear implant, implanted brain stimulators, aneurysm clips)
  • Active suicidality or psychosis
  • Existing diagnosis of Bipolar disorder, Autism Spectrum Disorder, mental retardation, or cognitive disability
  • Substance abuse or dependence
  • Taking a stimulant medication (and unwilling to forgo on study visit days)
  • Taking medication with the potential to lower seizure threshold (e.g., neuroleptics, antipsychotics)
  • Patient is a ward of the state
  • Family history of epilepsy
  • History of syncope

结局指标

主要结局

Change in Response Time on Stop Trials of the Stop Signal Task

时间窗: Change from pre (within 1 hour before) to post (within 1 hour after) intervention

Computerized task, where shorter response time (in milliseconds) indicates better performance

Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG)

时间窗: Change from pre (within 1 hour before) to post (within 1 hour after) intervention

Electroencephalogram (EEG) measured amplitude on successful stop trials of the stop signal task (SST). Calculated by averaging the epochs of successful stop trials time-locked to the stop signal from the midline electrode (Cz).

次要结局

  • Self-report Symptom Question(post (within 1 hour after) intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristen Benito

Associate Professor (Research)

Bradley Hospital

研究点 (2)

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