RTMS Targets Neural Circuits for Smoking Cessation
- Conditions
- Tobacco UseCigarette Smoking
- Interventions
- Device: Sham rTMSDevice: Active rTMS 10 Hz DLPFC
- Registration Number
- NCT04903028
- Lead Sponsor
- Medical University of South Carolina
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham rTMS Sham rTMS Investigators will use electrode stimulation with 10 Hz over DLPFC, total 3000 pulses. The sham-TMS scalp discomfort was matched to that of active TMS. During real TMS there was no current flowing through the scalp electrodes. Active rTMS 10 Hz DLPFC Active rTMS 10 Hz DLPFC A stimulation frequency of 10 Hz, pulse train duration (on time) of 5 seconds, inter-train interval (off time) of 10 seconds (15 second cycle time), E-field-modeling to determine TMS intensity and coil orientation, total of 60 trains, session time of 15 minutes, and 3000-total pulses per day, will be delivered over the left DLPFC.
- Primary Outcome Measures
Name Time Method 4 week continue quit rate 20 weeks Measured by self-report of smoking abstinence in the past 4 weeks and confirmed using urine cotinine measurement.
Cigarette per day 20 weeks Cigarette per day (CPD) is measured to index smoking reduction and cigarette consumption.
Adverse Event 4 weeks Participants will be asked about adverse events (AE) each visit during treatment. AEs will be measured each TMS treatment visit.
Task-functional connectivity from functional magnetic resonance imaging (fMRI) 4 week The strength of functional connectivity is used to present the brain activities. The fMRI scans will be measured before the first TMS, after 2 weeks TMS and after the last TMS treatment.
- Secondary Outcome Measures
Name Time Method Craving for cigarettes 4 weeks Measured with a visual analog scale (VAS). The VAS has 1-7 score. The minimum is 1 which means the lowest craving for smoking. The maximum value is 7 which is the highest craving for cigarettes. Participants will be asked to complete the scale each treatment visit.
Prolonged abstinence rate from end of treatment (Week 4) to end of follow-up (Week 20). 20 weeks Measured by self-report of smoking abstinence and confirmed using urine cotinine measurement.
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States