Produção Nacional
Revisado por pares
Preliminary characteristic of 45 patient of the study placebo-controlled, randomized, double-blind clinical trial to assess the safety and efficacy of using Deep Transcranial Magnetic Stimulation (EMTp) in smoking cessation.
2020; Elsevier BV; Volume: 13; Issue: 6 Linguagem: Inglês
10.1016/j.brs.2020.06.025
ISSN1935-861X
AutoresBianca Boura Bellini, Jaqueline Schölz Issa, Débora Arnaut, Tetsuya Abe, Rodrigo Lancelote Alberto, Carlotta Ferrari, Andrea Fontes Jafet, MJ Teixeira, Marco Antônio Marcolin,
Tópico(s)Transcranial Magnetic Stimulation Studies
ResumoBACKGROUND: Transcranial Magnetic Stimulation (TMS) is a non invasive technique to modulate neuronal activity. TMS and Deep TMS are promising tools to treat nicotine addiction. This study aims to evaluate the efficacy/safety of dTMS on smoking cessation. OBJECTIVE: Preliminary descriptive analysis. METHODS: Inclusion criteria: to smoke more than 10 cigarettes/day, over 1 year with no interruption above 3months; both gender; aged between 22-70 years. Exclusion criteria: psychiatric disorders other than depression and/or anxiety (HAM-D<15, HAM-A<25); Mini Mental Status Exam (MMSE) score < 24; TMS safety concerns (ex. pacemakers); Motor Threshold above 83. Sample: 100 patients. Design: 15 daily/sessions + 6 sessions, over 12 weeks. TMS Parameters: 10HZ, 3 sec on, 15 seconds off, 1,800 pulses/session, targeting bilaterally PFC and Insula, H-ADD coil. Tobacco provocation cues just before the session. RESULTS: At screening phases, 445 patients were evaluated; 28,5% gave up participating; 61,3% were excluded by study criteria. 54 patients were eligible (10.1%), therefore 9 screening failure. Randomized group had 45 patients to receive intervention: active dTMS or sham. 8 patients stopped smoking (18.2%). None of them had weight gain. Drop out rate were 31.8%. 22 patients completed the 21 sessions without successful stopping smoking (50 % of randomized group) The demographic characteristics showed: • 22,2 men x 77,8 women • 98% with high school completed • 77,8% actively working, 15,5% retired, 6,7% unemployed • Age statistical average of 46 years There was no statistically significant difference in the HAM-D and HAM-A scales between the groups (success or not). The final means indicate values within the normal range on both scales. DISCUSSION: Since smoking is highly comorbid it has been extremely difficult to find an eligible sample for this type of controlled study. Besides this, high dropout rate may reflect the attrition of the smokers what is well known in literature. It may also be linked to the availability of candidates to fulfill 21 treatment visits plus 3 neuro-psychologic evaluation visits. The weight gain is an important aspect of all smoking treatment and also more expressive in those who try to stop smoking spontaneously. Thus, it is very interesting to find no weight gain during the cessation process over all 8 successful patients; however we cannot yet associate it definitely with the method because the study is still blind.
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