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

C

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

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)

Trial contacts and locations

2

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Central trial contact

Emmanuel Haffen, Prof; Magali Nicolier, PhD

Data sourced from clinicaltrials.gov

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