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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

Tracking Information
First Submitted Date  ICMJE August 11, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date August 17, 2016
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
craving evaluated by item 1 of Fagerström test [ Time Frame: Day 30 ]
before and after the 10 sessions
Change History Complete list of historical versions of study NCT02867514 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Transcranial Direct Current Stimulation (tDCS) on Dependent Smoking People
Official Title  ICMJE Evaluation de l'Effet de la Stimulation Transcranienne en Courant Continu Chez Les Personnes Tabagiques dépendantes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Abuse Smoke
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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.
    Intervention: Device: transcranial Direct Current Stimulation (tDCS)
  • 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.
    Intervention: Device: transcranial Direct Current Stimulation (tDCS)
  • 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.
    Intervention: Device: transcranial Direct Current Stimulation (tDCS)
  • 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.
    Intervention: Device: transcranial Direct Current Stimulation (tDCS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 11, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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...)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867514
Other Study ID Numbers  ICMJE P/2012/133
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE Assistance Publique - Hôpitaux de Paris
Investigators  ICMJE
Principal Investigator: Emmanuel Haffen, Prof Centre Hospitalier Universitaire de Besancon
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP