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

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ClinicalTrials.gov Identifier: NCT02867514
Recruitment Status : Unknown
Verified August 2016 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : August 16, 2016
Last Update Posted : August 17, 2016
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.

Condition or disease Intervention/treatment Phase
Tobacco Abuse Smoke Device: transcranial Direct Current Stimulation (tDCS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation de l'Effet de la Stimulation Transcranienne en Courant Continu Chez Les Personnes Tabagiques dépendantes
Study Start Date : March 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

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 Name: 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 Name: 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 Name: 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 Name: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867514


Contacts
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Contact: Emmanuel Haffen, Prof +33381219007 emmanuel.haffen@univ-fcomte.fr
Contact: Magali Nicolier, PhD +33381219007 mnicolier@chu-besancon.fr

Locations
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France
CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808) Recruiting
Besancon, France
Contact: Emmanuel HAFFEN, MD PhD    +33381218154    emmanuel.haffen@univ-fcomte.fr   
Contact: Magali NICOLIER, PhD    +33381219007    mnicolier@chu-besancon.fr   
Principal Investigator: Emmanuel HAFFEN, MD PhD         
Assistance Publique - Hôpitaux de Paris Not yet recruiting
Paris, France
Contact: Frank Bellivier, MD PhD    (0)1 40 05 42 25 ext +33    frank.bellivier@inserm.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Emmanuel Haffen, Prof Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02867514     History of Changes
Other Study ID Numbers: P/2012/133
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
tobacco
craving
tDCS
attentional tasks
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders