Study has been FDA approved
Smoking is the leading cause of preventable deaths in the world. Each year, an estimated 443,000 people die prematurely from smoking or exposure to secondhand smoke, and another 8.6 million live with a serious illness caused by smoking. Smoking is not merely a destructive habit, but also a serious addiction. More than 85 percent of those who try to quit on their own relapse, most within a week.
The subjective and physiological effects of smoking are caused by the central actions of nicotine. Nicotine, like other drugs of abuse, activates the mesolimbic dopamine system, which originates in the ventral tegmental area (VTA) and projects to reward-related brain areas such as the prefrontal cortex (PFC), nucleus accumbens (NAc), amygdala and hippocampus. Decreased activity of the brain reward system during nicotine withdrawal has been associated closely with craving, relapse and continued nicotine.
rTMS May Be Useful in Treating Addicition
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive means of stimulating cortical neurons. Several lines of evidence suggest that rTMS over the prefrontal cortex (PFC) can affect processes involved in nicotine addiction. High-frequency rTMS of the prefrontal cortex (PFC) has been shown to be useful in treating addiction.
Secondly, stimulation of the dorsolateral PFC (DLPFC) can affect cue-induced craving. A course of rTMS sessions of the left DLPFC inhibits craving induced by smoking related cue. Direct current stimulation (DCS) of both left and right DLPFC reduces alcohol and nicotine craving induced by drug-associated cues.
Brainsway hypothesized that a course of deep high-frequency using a specific coil for deep stimulation, over the right and left lateral PFC and insula may reduce nicoteen craving. Deep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS, which allows direct stimulation of deep neuronal pathways. This new form of TMS makes use of Brainsway’s novel H-coils.
Preliminary Study Shows Promising Results
A preliminary study using the DTMS system was conducted at Beer Yaakov Mental Health Center (Beer Yaakov, Israel). The study found that using the H coil at 10 Hz in conjunction with a smoking cue produced very effective results.
We are now enrolling patients into a new study that will compare smoking cessation in two groups of subjects. One group will be assigned to the DTMS treatment (HADD-coil), and the other group will be assigned to the sham treatment (sham coil). The treatment group will receive 3 weeks of daily DTMS treatments with the HADD-coil, followed by 3 weekly DTMS treatments, for a total of 18 treatment sessions and 1800 magnetic stimulations per treatment session. The control group will receive the same treatments with a sham coil, for a total of 18 treatment sessions.
Participants will be asked to select a target quit date and to refrain from smoking nicotine for at least two hours prior to the baseline visit and prior to each treatment session. Prior to treatment stimulation onset, a smoking related cue will be presented to the subject. Immediately after the offset of the smoking cue presentation (while memory is reactivated) active or sham DTMS stimulation will be administered.
Participants will be asked to keep a record of their smoking behavior on a diary card. At each of the weekly visits, smoking behavior will be evaluated. All participants will receive counseling (at no cost) to help support them during their quit efforts.
Actively Enrolling Now
At the end of the 6-week period, participants who had quit smoking will be scheduled for a follow-up visit at 4 months (from the screening visit). Those who continue to smoke will complete an “end of study” form and will not be required to return for further follow-up. Participants will be given $20 per visit. For further information please complete the form below or contact Aron Tendler MD at (561)333-8884 or firstname.lastname@example.org.