MPFC Theta Burst Stimulation as a Tool to Affect Rational Decision Making
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
- 是
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
研究组 & 干预措施
Real TBS to the mPFC
The type of stimulation to be used will be intermittent theta burst (iTBS) stimulation to the mPFC with a figure 8 coil (Coil Cool-B65 A/P). Participants will receive three 3-minute sessions of iTBS (600 pulses; 190s; 120% resting motor threshold) with 10-15-minute breaks in between each session or more per participant preference.
干预措施: Real TBS to mPFC (Device)
Sham TBS to the mPFC
The MagVenture MagPro system has an integrated, active sham which passes current through two surface electrodes placed on the scalp. The electrodes will be placed on the left frontalis muscle for all sessions. A patient identification card will randomize participants to receive either sham or active stimulation in the first session.This system maintains blinding by a gyroscope in the coil which indicates to the clinical staff whether the coil should be rotated up or down for this participant once the card is entered into the machine. One side of the coil is active, the other is sham. The integrity of the double blind procedure will be assessed by asking the patients and study personnel rate their confidence regarding whether they thought they received real or sham. (Scale 1-10)
干预措施: Sham TBS to mPFC (Device)
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