Deep TMS for Smoking Cessation: Outcomes From a Phase IV Registry Study of the H4 Coil

Journal: Transcranial Magnetic Stimulation 3 (2025)

Authors: Tendler A, Daniel S, Roth Y, Pell G, Bermudes R, Hanlon C

Background:

In 2020, Deep Transcranial Magnetic Stimulation (Deep TMS) gained FDA clearance for short-term smoking cessation, demonstrating efficacy comparable to pharmacotherapies with minimal side effects.  

Objective:

This Phase IV registry study aimed to assess the real–world feasibility and efficacy of Deep TMS for smoking cessation. 

Methods:

Patients were prospectively enrolled from 22 clinical sites. TMS was delivered per protocol (H4 Coil, 15 sessions given 5 days per week followed by 3 sessions given 1 day per week, 120% resting motor threshold, 10Hz, 60 trains, 15 sec intertrain interval, 1800 pulses). Smoking cue-exposure was given before each treatment. Exhaled carbon monoxide levels and craving levels were evaluated throughout the trial. General linear models with repeated measures were used to quantify changes in smoking and craving over time. 

Results:

The 68 individuals enrolled smoked an average of one pack daily for 28.5 years, with five prior quit attempts. Thirty-six individuals completed the first 15 sessions per protocol (53%), wherein 49% achieved full smoking cessation (as verified by timeline follow back and exhaled carbon monoxide) (F=9.5, p=0.004). There was also a significant decrease in cigarette craving across the group (F=6.2, p=0.02). The primary motivation of the ITT group and quitters was health concerns. A rebate incentive program increased the quit rate by 10%. 

Conclusions:

Fifteen sessions of Deep TMS was effective for short–term smoking cessation among refractory chronic smokers. Lack of insurance coverage in the United States, however, limits access to this treatment. Addressing this obstacle is crucial to broader adoption of TMS for smoking cessation. 

Read full article