Asthma Clinical Trial
Official title:
Multidisciplinary Tools for Improving the Efficacy of Public Prevention Measures Against Smoking
This study will develop and experimentally test the efficiency of a neurofeedback training protocol vs. varenicline use for smoking cessation.
This study will develop and experimentally test the efficiency of a neurofeedback(NF)
training protocol for smoking cessation. As non-pharmacological, non-invasive and painless
brainwave technique, NF contributes to teach individuals how they can take the control of
their mind through operant conditioning. NF regulates brain function in natural way. Studies
have reported an 80% rate of reducing or eliminating the need for traditional medication14.
Therefore, other nicotine substitutes (such as varenicline) which may carry their own
toxicity risk factor may become redundant. The protocol will include 5 bio- and 25
Neuro-feedback sessions, lasting approximately 36 months.
The electrophysiological evaluation of the efficacy of the intervention will include EEG
resting state and a multifeature Mismatch Negativity (MMN) evoked response measurements
before and after the participation of human volunteers. These data will be analyzed in terms
of cortical activation patterns and cortical connectivity. Questionnaires will be used to
collect behavioral and psychometric data regarding smoking related behaviors. Additionally, a
clinical evaluation including spirometry, exhaled carbon monoxide, total antioxidant
capacity, vitamine E, and cotinine will be conducted. The data will be collected prior,
during, after the completion of the study and after a one-year follow up.
The Neurofeedback intervention will be compared to a different group of participants that
will follow an intervention based on varenicline use for approximately 3 months. The
electrophysiological evaluation of the efficacy of the intervention will include EEG resting
state and a sleep polysomnography measurement. Questionnaires and clinical evaluation include
the same measurements as the neurofeedback intervention but only in 3 time points: prior,
during, after the completion of the study.
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