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

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Tobacco Abuse Smoke

Treatments: Device: transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02867514

P/2012/133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 4 patient groups

anodal tDCS on left DLPFC (F3)

Active Comparator group

Description:

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.

Treatment:

Device: transcranial Direct Current Stimulation (tDCS)

sham tDCS on left DLPFC (F3)

Sham Comparator group

Description:

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.

Treatment:

Device: transcranial Direct Current Stimulation (tDCS)

anodal tDCS on right DLPFC (F4)

Active Comparator group

Description:

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.

Treatment:

Device: transcranial Direct Current Stimulation (tDCS)

sham tDCS on right DLPFC (F4)

Sham Comparator group

Description:

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.

Treatment:

Device: transcranial Direct Current Stimulation (tDCS)