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

Not Applicable

• Conditions: Tobacco Abuse Smoke
• Interventions: Device: transcranial Direct Current Stimulation (tDCS)

• Registration Number: NCT02867514
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-03
• Status Verified: 2016-08
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-16
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anodal tDCS on left DLPFC (F3)	transcranial Direct Current Stimulation (tDCS)	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.
sham tDCS on left DLPFC (F3)	transcranial Direct Current Stimulation (tDCS)	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.
sham tDCS on right DLPFC (F4)	transcranial Direct Current Stimulation (tDCS)	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.
anodal tDCS on right DLPFC (F4)	transcranial Direct Current Stimulation (tDCS)	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.

Primary Outcome Measures

Name	Time	Method
change from baseline in craving evaluated by item 1 of Fagerström test	baseline, day 10 and 1 month post-ttt	before and after the 10 sessions

Trial Locations

Locations (2)

Assistance Publique - Hôpitaux de Paris; 🇫🇷 Paris, France

CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808); 🇫🇷 Besancon, France