Evaluation de l'Effet de la Stimulation Transcranienne en Courant Continu Chez Les Personnes Tabagiques dépendantes
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- change from baseline in craving evaluated by item 1 of Fagerström test
研究概览
简要总结
The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left vs right CDLPF of tobacco-dependent subjects compared to the application of a placebo tDCS (sham procedure) on the craving, which is evaluated by the item 1 of Fagerström test between day 1 and day 10. Craving is also evaluated 1 month post-treatment.
详细描述
Tobacco is the second leading cause of death worldwide. It is currently responsible for the death of one in 10 adults (about 5 million deaths per year) and it is the fourth disease risk factor in the world. Many methods to quit smoking are available but in all cases, relapse is a common phenomena. The main risk factor for relapse is craving. So, acting on the craving seems essential to modulate tobacco consumption. Many functional neuroimaging studies have established a neuroanatomical substrate for craving process, in particularly dorsolateral prefrontal cortex (DLPFC), accessible par neuromodulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fagerström score ≥ 5
- •Q-MAT score ≥ 6
- •smoking subjects from 10 to 30 cigarettes a day
- •right-handed subjects
- •w/o severe progressive somatic pathology (especially tumor diseases, degenerative diseases)
- •Hamilton Depression Rating Scale-17 score <18
排除标准
- •pregnancy and/or lactation
- •presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker...)
研究组 & 干预措施
anodal tDCS on left DLPFC (F3)
tDCS is a non-invasive neuromodulation method, which delivers a constant current of low intensity (1 mA) during 30 min for 10 sessions. Anode is placed on the scalp facing on left DLPFC and cathode on right DLPFC.
干预措施: transcranial Direct Current Stimulation (tDCS) (Device)
sham tDCS on left DLPFC (F3)
tDCS differs from active tDCS by the interruption of stimulation after 15 sec and reactivation of the stimulation 15 sec before the end of the session (30 min - 10 sessions). Anode is placed on the scalp facing on left DLPFC and cathode on right DLPFC.
干预措施: transcranial Direct Current Stimulation (tDCS) (Device)
anodal tDCS on right DLPFC (F4)
tDCS is a non-invasive neuromodulation method, which delivers a constant current of low intensity (1 mA) during 30 min for 10 sessions. Anode is placed on the scalp facing on right DLPFC and cathode on left DLPFC.
干预措施: transcranial Direct Current Stimulation (tDCS) (Device)
sham tDCS on right DLPFC (F4)
tDCS differs from active tDCS by the interruption of stimulation after 15 sec and reactivation of the stimulation 15 sec before the end of the session (30 min - 10 sessions). Anode is placed on the scalp facing on right DLPFC and cathode on left DLPFC.
干预措施: transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
change from baseline in craving evaluated by item 1 of Fagerström test
时间窗: baseline, day 10 and 1 month post-ttt
before and after the 10 sessions
次要结局
未报告次要终点