Accelerated iTBS in Smoking Cessation
Condition: Nicotine Dependence; Smoking Cessation
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Cigarette smoking is one of the foremost causes of preventable disease and premature death.
      In 2014, 68% of adult smokers wanted to quit smoking and in 2017, 55.1% of adult smokers had
      made a quit attempt. However, only a small percentage of adult smokers (7,4%) achieved to
      quit smoking.

      Transcranial magnetic stimulation (TMS) is a novel, powerful, non-invasive brain stimulation
      therapy. This study used Theta Burst Stimulation (TBS), a newer form of rTMS protocol that
      can be delivered in a shorter duration compared to the standard rTMS protocol, while
      delivering a comparable number of pulses. It is a tolerable, powerful, and useful tool in
      non-invasive brain stimulation therapies.

      This double-blind randomized control trial evaluated the efficacy of 4 iTBS sessions per day
      during 5 consecutive days over the left DLPFC in smoking cessation. Moreover, it investigated
      whether the exposure to smoking-related cues during the rTMS treatment, compared to neutral
      cues impact cigarette craving.
    

Detailed description: 
      Cigarette smoking is one of the foremost causes of preventable disease and premature death.
      In 2014, 68% of adult smokers wanted to quit smoking and in 2017, 55.1% of adult smokers had
      made a quit attempt. However, only a small percentage of adult smokers (7,4%) achieved to
      quit smoking. Behavioral and psychological interventions, pharmacological interventions as
      well as nicotine replacement therapy are some of the most used interventions for smoking
      cessation with medium to low success rates. Nonetheless, in recent years there has been
      growing interest in new, alternative, and effective treatments for smoking cessation.

      Transcranial magnetic stimulation (TMS) is a novel, powerful, non-invasive brain stimulation
      therapy. TMS non-invasively (transcranially) delivers magnetic pulses to a brain region,
      inducing electric a current that can depolarize neurons and induce action potentials. This
      study used Theta Burst Stimulation (TBS), a newer form of rTMS protocol that can be delivered
      in a shorter duration compared to the standard rTMS protocol, while delivering a comparable
      number of pulses. It is a tolerable, powerful, and useful tool in non-invasive brain
      stimulation therapies.

      This double-blind randomized control trial evaluated the efficacy of 4 iTBS sessions per day
      during 5 consecutive days over the left DLPFC in smoking cessation. Moreover, it investigated
      whether the exposure to smoking-related cues during the rTMS treatment, compared to neutral
      cues impact cigarette craving. The investigators hypothesized that twenty sessions of
      accelerated theta burst simulation over the left DLPFC while exposed to smoking-related cues,
      would reduce cigarette consumption and cigarette cravings, accompanied by reduced stress and
      motivation to quit smoking, compared to both active and sham stimulation with neutral-cues.

      A total of 104 cigarettes smokers, who wanted to quit smoking, were enrolled and were
      randomly divided into the three experimental groups: the first group received active aiTBS
      stimulation while watching neutral videos, the second group received active aiTBS stimulation
      while watching smoking-related videos and the last group received sham stimulation while
      watching smoking-related videos. Primary and secondary measurements were performed at the
      baseline, during the treatment period, at one week, one month and six months post rTMS
      treatment.
    

Intervention name(s): Active intermittent theta burst stimulation; Sham intermittent theta burst stimulation
Intervention type(s): Device; Device
Intervention description(s): An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.; An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment