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临床试验/NCT05631548
NCT05631548已完成不适用

Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年2月23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
6
试验地点
2
主要终点
Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEG

研究概览

简要总结

The purpose of this study is to assess the effects of active intermittent theta burst stimulation (iTBS) to dorsomedial prefrontal cortex (dmPFC) on electroencephalogram (EEG) measures of reward sensitivity and cue reactivity and cocaine craving in cocaine users

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • CUD diagnosis

排除标准

  • moderate or severe criteria for substances other than cocaine, cannabis, or nicotine
  • unstable psychiatric disorder
  • medical conditions contraindicated to TMS (e.g., medical implants, history of seizure or seizure disorder, medications lowering the seizure threshold, neurological conditions, moderate-to-severe heart disease)
  • pregnancy
  • hairstyles incompatible with the EEG net
  • head injury with loss of consciousness

结局指标

主要结局

Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEG

时间窗: Immediately after iTBS session

The Doors Task will be used to elicit the Reward Potential (RewP) component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up (win) or if they did not find the prize by a red arrow pointing down (loss). The amplitude of the RewP in microvolts in response to feedback is reported.

Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by EEG

时间窗: Immediately after iTBS session

The Picture Viewing Task will be used to elicit the late positive potential (LPP), reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slideshow of images including pleasant, unpleasant, neutral, and cocaine-related images. The amplitude of the LPP in microvolts in response to visual stimuli is reported.

次要结局

  • Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS)(Immediately after iTBS session)
  • Cognitive Function as Assessed by the The Montreal Cognitive Assessment (MoCA)(Immediately after iTBS session)
  • Pain as Assessed by the Visual Analog Scale (VAS)(Immediately after iTBS session)
  • Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)(Baseline(before iTBS session))

研究者

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

Heather E. Webber, PhD

Instructor

The University of Texas Health Science Center, Houston

研究点 (2)

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