NCT01560351终止不适用
Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
The aim of this study is to evaluate the effect of repeated low-frequency Transcranial Magnetic Stimulation (rTMS) of the right dorsolateral prefrontal cortex, combined with gambling cues, on gambling craving. Participants are pathological gamblers. A single real stimulation and a single shame stimulation are administered in a random order for each participant (cross-over study).
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
- Double (Participant, Investigator)
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
- 否
入选标准
- •Pathological gambler (DSM-IV criteria)
- •Seeking treatment at the University Hospital of Nantes
- •Right-handed
- •18-65 years old
- •Increase in the intensity (at least 50%) of the gambling craving with gambling cues
- •Non-inclusion criteria:
- •pregnant woman
- •no effective contraception
- •Substance use disorders (excluding nicotine)
- •Benzodiazepine use
- •Chronic neurological disease
- •History of head injury
- •History of neurosurgery
- •Cochlear implant or other metal objects in the head
- •History of Transcranial Magnetic Stimulation or repeated Transcranial
- •Magnetic Stimulation
- •Difficult to read or write French
排除标准
- •Occurrence of side effects (like seizures)
- •Psychoactive substance use 12 hours before the rTMS (excluding nicotine)
研究组 & 干预措施
rTMS
Experimental
Session of repeated low-frequency Transcranial Magnetic Stimulation
干预措施: rTMS (Device)
Placebo
Sham Comparator
Sessions of sham rTMS
干预措施: rTMS (Device)
结局指标
主要结局
Visual Analogue Scale (VAS)
Cue-induced craving is evaluated using a VAS, immediately before and immediately after the administration of the craving cues, and immediately after the rTMS session (real and sham).
次要结局
- Visual Analogue Scale (VAS)
- Gambling Craving Scale (GACS)
- blood pressure
- heart rate
研究者
研究点 (1)
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