Repetitive Transcranial Magnetic Stimulation (rTMS) for Nicotine Addiction
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Cigarette smoking remains a significant public health concern. A magnetic field applied to
      the outside of the skull can produce electrical activity in the brain without significant
      pain or the need for anesthesia. Sessions of magnetic stimulation or superficial stimulation
      that does not reach the brain will be used to determine if magnetic stimulation can reduce
      cue-induced craving and cigarettes consumption in adult nicotine-dependent cigarette smokers.
      This project may lead to a new therapy for smoking cessation.
    

Detailed description: 
      Cigarette smoking causes significant morbidity and mortality in the United States. Smoking
      cessation is difficult, with the average smoker attempting to quit five times before
      permanent success. Moreover, the majority of smoking quit attempts result in relapse. Brain
      stimulation for smoke cessation is an exciting new area that builds on advancing neuroscience
      knowledge concerning the functional neurocircuitry of addiction. Cortical stimulation can now
      be performed non-invasively by transcranial magnetic stimulation (TMS). A few studies have
      shown that TMS can reduce cue-elicited craving in smokers. Previous research by our group has
      shown that a single session of 15 minutes high frequency (10 Hz) repetitive TMS (rTMS) at
      100% motor threshold over the left dorsal lateral prefrontal cortex (an area that is likely
      involved in inhibiting craving) can reduce cue-induced craving compared to sham TMS. However,
      methodological concerns surrounding these preliminary findings limit definitive conclusions
      about the effectiveness of TMS over a longer period of time. This R21 proposal will integrate
      more rigorous experimental conditions, a true double-blind methodology, MRI guided
      stimulation site and a longer-term follow-up assessment. Using rigorous double-masked methods
      and MRI guided stimulation site, we propose that using active rTMS or sham rTMS, to determine
      whether 10 sessions over a two week period consisting of 15 minute high frequency rTMS can
      reduce cue-induced craving and cigarette consumption for cigarette smokers. The project will
      also optimize rational rTMS parameters to make TMS to an efficacious treatment for nicotine
      dependence. In the two years of project, we plan to recruit 42 treatment-seeking
      nicotine-dependent cigarette smokers, both males and females of all ethnic and racial groups
      between the ages of 18 and 60 to participate in the study. The 42 participants will be
      randomly assigned to receive active prefrontal TMS or sham prefrontal TMS. The data from this
      R21 will provide the information needed for launching a definitive larger-scale investigation
      into potential clinical applications of TMS in smoke cessation. The results from this pilot
      will also likely supply substantial information about the utility of cortical stimulation for
      smoke cessation.
    

Intervention name(s): Transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TMS; nicotine dependence; smoking cessation