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临床试验/NCT05917002
NCT05917002撤回不适用

MPFC Theta Burst Stimulation as a Tool to Affect Rational Decision Making

Medical University of South Carolina0 个研究点目标入组 30 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
30
主要终点
Baratt Impulsiveness Scale

研究概览

简要总结

This is a study to investigate if a device that temporarily changes brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how healthy participants make decisions. This study involves 2 visits to MUSC that will each take between 2-3 hours. This study is not a treatment study, but it could help inform studies investigating treatment in the future. Participants in this study will be compensated for their time.

详细描述

This study aims to investigate whether a single session of excitatory repetitive transcranial magnetic stimulation (rTMS) compared to electrical sham stimulation to the medial prefrontal cortex (mPFC) facilitates rational decision making. Our prior data suggests that decisions are biased depending on if the available options are presented with a negative or positive connotation (even in the case of mathematical equivalence). Work by us and others has demonstrated that even if both options are equal, the negatively framed choice is most often avoided.

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, Investigator)

盲法说明

This study is double blinded. Both the investigators and the participants will be blinded as to which method of stimulation they receive first.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Is able to read consent document and provide informed consent
  • English is first or primary language

排除标准

  • • Current psychiatric disorder (as defined by DSM-5 and determined using standardized self-report instruments)
  • Suicide attempt in the past year
  • Lifetime diagnosis of psychotic disorder or bipolar mania
  • Presence of neurological disorder that contraindicates TMS or neurophysiological recording:
  • Seizure disorder
  • Lifetime history of traumatic brain injury with loss of consciousness
  • Neurodegenerative disorder (e.g., Alzheimer's Disease, Parkinson's Disease, Frontotemporal Dementia)
  • Presence of standard contraindications for rTMS
  • Currently pregnant
  • Significant sensitivity to noise
  • Medical treatments or conditions that lower seizure threshold
  • History of severe brain injury
  • History of seizures/epilepsy
  • Currently taking chronic opiate medications or substances
  • Inability or unwillingness of subject to give informed consent

结局指标

主要结局

Baratt Impulsiveness Scale

时间窗: Change assessed at visit 1 (day 1) and visit 2 (day 2)

Change in 30-item self-report scale that is commonly used to measure impulsiveness. Participants respond to each item using a 4-point Likert scale: 1 (rarely/never), 2 (occasionally), 3 (often), and 4 (almost always/always).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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