Effect of the Transcranial Direct Current Stimulation (tDCS) on Dependent Smoking People

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation de l'Effet de la Stimulation Transcranienne en Courant Continu Chez Les Personnes Tabagiques dépendantes

Conditions
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Tobacco Abuse Smoke

Intervention / Treatment
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* Device: transcranial Direct Current Stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: pregnancy and/or lactation presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker...)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anodal tDCS on left DLPFC (F3)<br>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. | Device: transcranial Direct Current Stimulation (tDCS)<br>* After locating the stimulation areas, treatment will be delivered during 30-minute session. Treatment will be occur 1 session per day during 10 days (5 days per week during 2 successive weeks). Subjects will be monitored during tDCS for any side effects or adverse events.<br>* Other names: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany);|
| Sham Comparator: sham tDCS on left DLPFC (F3)<br>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. | Device: transcranial Direct Current Stimulation (tDCS)<br>* After locating the stimulation areas, treatment will be delivered during 30-minute session. Treatment will be occur 1 session per day during 10 days (5 days per week during 2 successive weeks). Subjects will be monitored during tDCS for any side effects or adverse events.<br>* Other names: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany);|
| Active Comparator: anodal tDCS on right DLPFC (F4)<br>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. | Device: transcranial Direct Current Stimulation (tDCS)<br>* After locating the stimulation areas, treatment will be delivered during 30-minute session. Treatment will be occur 1 session per day during 10 days (5 days per week during 2 successive weeks). Subjects will be monitored during tDCS for any side effects or adverse events.<br>* Other names: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany);|
| Sham Comparator: sham tDCS on right DLPFC (F4)<br>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. | Device: transcranial Direct Current Stimulation (tDCS)<br>* After locating the stimulation areas, treatment will be delivered during 30-minute session. Treatment will be occur 1 session per day during 10 days (5 days per week during 2 successive weeks). Subjects will be monitored during tDCS for any side effects or adverse events.<br>* Other names: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in craving evaluated by item 1 of Fagerström test | before and after the 10 sessions | baseline, day 10 and 1 month post-ttt | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco, craving, tDCS, attentional tasks