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

NCT ID: NCT02867514

Last Updated: 2016-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-07-31

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.

Conditions

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Tobacco Abuse Smoke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

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.

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.

Group Type SHAM_COMPARATOR

transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

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.

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.

Group Type SHAM_COMPARATOR

transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

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.

Interventions

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transcranial Direct Current Stimulation (tDCS)

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.

Intervention Type DEVICE

Other Intervention Names

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EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)

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...)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel Haffen, Prof

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Besancon

Locations

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CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)

Besançon, , France

Site Status RECRUITING

Assistance Publique - Hôpitaux de Paris

Paris, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Emmanuel Haffen, Prof

Role: CONTACT

+33381219007

Magali Nicolier, PhD

Role: CONTACT

+33381219007

Facility Contacts

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Emmanuel HAFFEN, MD PhD

Role: primary

+33381218154

Magali NICOLIER, PhD

Role: backup

+33381219007

Frank Bellivier, MD PhD

Role: primary

(0)1 40 05 42 25 ext +33

Other Identifiers

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P/2012/133

Identifier Type: -

Identifier Source: org_study_id

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