NCT02867514

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

3.3 years

First QC Date

August 11, 2016

Last Update Submit

August 16, 2016

Conditions

Tobacco Abuse Smoke

Keywords

tobaccocravingtDCSattentional tasks

Outcome Measures

Primary Outcomes (1)

  • change from baseline in craving evaluated by item 1 of Fagerström test

    before and after the 10 sessions

    baseline, day 10 and 1 month post-ttt

Study Arms (4)

anodal tDCS on left DLPFC (F3)

ACTIVE COMPARATOR

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)

sham tDCS on left DLPFC (F3)

SHAM COMPARATOR

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)

anodal tDCS on right DLPFC (F4)

ACTIVE COMPARATOR

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)

sham tDCS on right DLPFC (F4)

SHAM COMPARATOR

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)

Interventions

transcranial Direct Current Stimulation (tDCS)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.

Also known as: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)
anodal tDCS on left DLPFC (F3)anodal tDCS on right DLPFC (F4)sham tDCS on left DLPFC (F3)sham tDCS on right DLPFC (F4)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy and/or lactation
  • presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Besançon, France

RECRUITING

Assistance Publique - Hôpitaux de Paris

Paris, France

NOT YET RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Emmanuel Haffen, Prof

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Haffen, Prof

CONTACT

+33381219007emmanuel.haffen@univ-fcomte.fr

Magali Nicolier, PhD

CONTACT

+33381219007mnicolier@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

March 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 17, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)