NCT04903028

RTMS Targets Neural Circuits for Smoking Cessation

RTMS Manipulates Imbalanced Drive-reward and Executive Control Circuitry for Smoking Cessation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers. In this study, investigators will use brain MRI to guide TMS therapy for smoking cessation.

Detailed description

Smoking cessation is difficult, despite the demonstrated efficacy of several pharmacotherapeutic agents and cognitive behavioral therapies. This may be due to imbalanced neuronal circuits, including elevated functional connectivity in the drive-reward circuit (medial orbital frontal cortex \[mOFC\] to nucleus accumbens \[NAc\]) and decreased functional connectivity in the executive control circuit (dorsolateral prefrontal cortex\[ DLPFC\] to NAc). Repetitive transcranial magnetic stimulation (rTMS) is a new class of therapeutics that has already displayed remarkable potential for producing novel, non-pharmacological interventions for neuropsychiatric disorders. Previous studies have reported that rTMS decreased cue craving, reduced cigarette consumption, and increased smoking quit rate in tobacco use disorders(TUDs). However, the treatment parameters and exact mechanism for rTMS increasing smoking quit rate need further refinement. The goal of this study is to develop a circuit-based precision rTMS therapy for smoking cessation further. In the 3-year UH3 phase, investigators will conduct a randomized, double-blinded, sham-controlled trial of rTMS in 64 treatment-seeking tobacco use disorders (TUDs) smokers. Participants will be randomized to one of two conditions: 1\. Sham rTMS, or 2. Active 10 Hz personalized-fMRI and E-field-modeling guided rTMS over the left dorsolateral prefrontal cortex (DLPFC). All participants will receive 20 daily sessions of rTMS over 4 weeks. Functional MRI scans will be performed prior to the first TMS treatment, after TMS session 10, and after the last TMS treatment session. All participants will have a one-week follow-up and 4 monthly follow-up visits (after the last TMS session 1 week, 1 month, 2 months, 3 months, and 4 months) after the last TMS session.

Conditions

• Tobacco Use
• Cigarette Smoking

Interventions

Type	Name	Description
DEVICE	Sham rTMS	Two electrodes on the scalp will be connected to transcutaneous electrical nerve stimulation.
DEVICE	Active rTMS 10 Hz DLPFC	10 Hz repetitive transcranial magnetic stimulation (rTMS) will be delivered over left dorsolateral prefrontal cortex (DLPFC).

Timeline

• Start date: 2021-05-15
• Primary completion: 2027-02-28
• Completion: 2027-04-04
• First posted: 2021-05-26
• Last updated: 2026-04-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study