NCT06347055招募中不适用
Neuronavigated Non-invasive Brain Stimulation for Nicotine Dependence.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Acute effects of cTBS on cognitive control
研究概览
简要总结
The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Nicotine Dependence as measured by: Smoke ≥ 8 cigarettes/day for ≥ 2 yrs, expired carbon monoxide (CO) concentration of ≥ 10 ppm, positive urine cotinine test and FTND score ≥ 3 Or ≥ 15 uses of electronic cigarette/day for ≥ 1 year, positive urine cotinine test, and PS-ECDI score ≥ 3
- •English Fluency
- •Functional Vision (with corrective lenses as needed)
排除标准
- •Use of psychotropic and antiepileptic medications in the last month
- •Presence of an untreated illness or serious medical condition
- •History of major neurological illness
- •Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for >15 min., implanted electronic device, metal in the head) or MRI.
- •Any use of substances that lower seizure threshold.
- •Current or past psychosis
- •Electroconvulsive therapy in the past 6 months
- •Unstable cardiac disease or hypertension, severe renal or liver insufficiency, or sleep apnea
- •BAC greater than 0.
- •Positive urine pregnancy test
- •Any other concern that in the investigator's opinion would impact participant safety, study instruction compliance, or confound the interpretation of the study results.
结局指标
主要结局
Acute effects of cTBS on cognitive control
时间窗: 1 hour after receiving cTBS
between-arm differences in neurocognitive task performance as measured by percent correct on an inhibitory control task and self reported craving on a regulation of craving task.
次要结局
- Exploratory: Acute effects of cTBS on fMRI brain response(1 hour after receiving cTBS)
研究者
Brett Froeliger
Professor
University of Missouri-Columbia
研究点 (2)
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