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

Primary Purpose

Tobacco Abuse Smoke

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation (tDCS)
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Abuse Smoke focused on measuring tobacco, craving, tDCS, attentional tasks

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts 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...)

Sites / Locations

  • CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)Recruiting
  • Assistance Publique - Hôpitaux de Paris

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

anodal tDCS on left DLPFC (F3)

sham tDCS on left DLPFC (F3)

anodal tDCS on right DLPFC (F4)

sham tDCS on right DLPFC (F4)

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

change from baseline in craving evaluated by item 1 of Fagerström test
before and after the 10 sessions

Secondary Outcome Measures

Full Information

First Posted
August 11, 2016
Last Updated
August 16, 2016
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02867514
Brief Title
Effect of the Transcranial Direct Current Stimulation (tDCS) on Dependent Smoking People
Acronym
TabaSCo
Official Title
Evaluation de l'Effet de la Stimulation Transcranienne en Courant Continu Chez Les Personnes Tabagiques dépendantes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Abuse Smoke
Keywords
tobacco, craving, tDCS, attentional tasks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anodal tDCS on left DLPFC (F3)
Arm Type
Active Comparator
Arm 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.
Arm Title
sham tDCS on left DLPFC (F3)
Arm Type
Sham Comparator
Arm 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.
Arm Title
anodal tDCS on right DLPFC (F4)
Arm Type
Active Comparator
Arm 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.
Arm Title
sham tDCS on right DLPFC (F4)
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)
Intervention Description
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.
Primary Outcome Measure Information:
Title
change from baseline in craving evaluated by item 1 of Fagerström test
Description
before and after the 10 sessions
Time Frame
baseline, day 10 and 1 month post-ttt

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel Haffen, Prof
Phone
+33381219007
Email
emmanuel.haffen@univ-fcomte.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Magali Nicolier, PhD
Phone
+33381219007
Email
mnicolier@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Haffen, Prof
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)
City
Besancon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel HAFFEN, MD PhD
Phone
+33381218154
Email
emmanuel.haffen@univ-fcomte.fr
First Name & Middle Initial & Last Name & Degree
Magali NICOLIER, PhD
Phone
+33381219007
Email
mnicolier@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Emmanuel HAFFEN, MD PhD
Facility Name
Assistance Publique - Hôpitaux de Paris
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Bellivier, MD PhD
Phone
(0)1 40 05 42 25 ext +33
Email
frank.bellivier@inserm.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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