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Circuity-guided Repetitive Transcranial Magnetic Stimulation (rTMS) for Tobacco Use in Veterans: A Comparison of Insula-rTMS and Prefrontal-rTMS

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Cigarette smoking is a significant public health concern for Veterans. Encouraging smoking cessation continues to be a top priority for the Veterans' Administration as Veterans who use tobacco experience negative health effects, including cancer, heart disease, and mental disorders. Despite the efficacy of current evidence-based pharmacotherapies and psychotherapies for smoking cessation, alternative treatments are critically needed. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive form of brain stimulation, US FDA-approved for smoking cessation. In this protocol, the investigators propose comparing the two rTMS protocols (standard TMS vs. precision TMS) to find a better treatment parameter for smoking cessation in Veterans. Identifying an efficacious rTMS protocol would benefit Veterans who want to quit smoking.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Veteran

• Individuals who smoke 10 or more cigarettes per day and have a CO level \> 10 ppm indicative of recent smoking

• Those who have not received substance abuse treatment within the previous 30 days

• Those who have been stable on psychotropic medications for at least three months

• For females, those who test non-pregnant and use adequate birth control

• Those who are willing to provide informed consent

• Those who can comply with protocol requirements and likely complete all study procedures

• Those who are motivated to quit smoking (based on responses of very likely or somewhat likely in the motivation questionnaire

Locations
United States
South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
RECRUITING
Charleston
Contact Information
Primary
Xingbao Li, MD MS
xingbao.li@va.gov
(843) 577-5011
Backup
Aimee L Mcrae-Clark, PharmD
Aimee.McRae-Clark@va.gov
(843) 792-5216
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2030-08-31
Participants
Target number of participants: 56
Treatments
Active_comparator: Deep rTMS
The first group will receive 10 Hz DTMS (standard TMS) with a protocol of 3 seconds on, 15 seconds off, and a total of 1800 pulses/session, lasting 18 minutes, targeting the bilateral insula and lateral prefrontal cortex.
Experimental: Precision TMS
The other group will receive 10 Hz personalized-image-guided and Efield-modeling dose rTMS (precision TMS) with a protocol of 5 seconds on, 10 seconds off, and a total of 3000 pulses/session, lasting 15 minutes, targeting the left dorsolateral prefrontal cortex (DLPFC).
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov