Direct Transcranial Electrical Stimulation in Tobacco Addiction (tDCS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Direct Current Stimulation.
- Who it may be relevant to
- Registry conditions: Adults (Male and Female Subjects) With Tobacco Dependence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effect of Transcranial Direct Current Stimulation (tDCS) in Nicotine-Dependent Tobacco Users
Overview
In summary, there are currently many therapeutic tools for achieving some degree of control or even cessation of tobacco addictive use. No single therapy seems to have proven itself sufficiently effective to be the preferred treatment axis in the management of this addiction. We can also point out that so far the main treatments aimed at reducing or controlling the craving phenomenon are of a pharmacological nature, thus exposing the participants to the side effects inherent to this type of treatment. In this perspective, the establishment of non invasive brain stimulation (TdCS), acting in a targeted manner on craving and whose effects would be mild and transient, appears quite justified, especially in addition to psychotherapy. In the context of the management of addictive pathologies, the choice of smoking dependence seems relevant to us insofar as this addiction represents a major public health problem.
Interventions
- Other Transcranial Direct Current Stimulation
tDCS sessions (with Direct Transcranial Electrical Stimulation (tDCS) device - Neuroelectrics
Primary outcome measures
- Fagerström score (3 is the highest score and O the lowest one for item 1. A score of 1 or 2 means low dependence (for item 1 only as well as if you use the total score) [Time frame: 15 days]
Secondary outcome measures (1)
- tobacco consumption [Time frame: 15 days]
Eligibility criteria
Inclusion criteria
- Men and women over the age of 18
- Nicotine dependent subjects according to the Fagerström test (score ≥5)
- Subjects consuming daily tobacco.
- Subjects understanding and reading French and able to express themselves in this language.
- Signed informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study and agrees to participate in the study and to comply with the requirements and limitations of this study
- Affiliation to the French social security scheme or beneficiary of such a scheme.
- No other method to decrease or stop smoking at the same time as the study.
Exclusion criteria
- Guardianship
- Pregnant or lactating woman
- Patient under AME
- Subject being in the exclusion period of another study or provided for by the "National Volunteer File".
- Subjects with intracranial hypertension
- Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator.
- Treatment with buproprion or varenicline in progress
- Episode or family history of epilepsy, convulsion.
- Disease causing damage to the brain (aneurysm, tumor, ...).
- Cochlear or ocular implant.
- Stimulator or cardiac defibrillator.
- Presence of metal in the skull (clip on aneurysm, prosthesis, ...).
- Eczema on the scalp.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Psychiatrie Adultes Et Addictologie — Paris
Identifiers
NCT: NCT04209153 · APHP190731 · 2019-A01946-51