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

August 16, 2016 updated by: Centre Hospitalier Universitaire de Besancon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France
        • Recruiting
        • CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)
        • Contact:
      • Paris, France
        • Not yet recruiting
        • Assistance Publique - Hopitaux de Paris
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Device: 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.
Other Names:
  • EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)
SHAM_COMPARATOR: 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.
Device: 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.
Other Names:
  • EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)
ACTIVE_COMPARATOR: 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.
Device: 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.
Other Names:
  • EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)
SHAM_COMPARATOR: 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.
Device: 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.
Other Names:
  • EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Emmanuel Haffen, Prof, CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

July 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (ESTIMATE)

August 16, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2012/133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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