rTMS for Tobacco Use in Veterans
Circuity-guided Repetitive Transcranial Magnetic Stimulation (rTMS) for Tobacco Use in Veterans: A Comparison of Insula-rTMS and Prefrontal-rTMS
2 other identifiers
interventional
56
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2025
CompletedFirst Posted
Study publicly available on registry
July 3, 2025
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2030
Study Completion
Last participant's last visit for all outcomes
August 31, 2030
April 8, 2026
April 1, 2026
3.8 years
May 15, 2025
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cigarettes per day
The investigators will compare the reduction of cigarette consumption between the two treatment groups at the end of the 3-week rTMS treatment. A higher reduction of CPD means a better treatment result.
The cigarettes per day will be measured up to 3 weeks for the outcome 1
Brain Imaging Outcomes - Cue Craving Scans
fMRI scans of all Veterans to look at brain function connectivity. The investigators will compare the changes of brain activity between two treatment conditions.
3-weeks
Secondary Outcomes (10)
7-day continuous quit rate (CQR)
10 week
Likert Visual Analog Cue Craving Scale
10 weeks
Fagerstrom Test for Nicotine Dependence (FTND)
10 weeks
Minnesota Nicotine Withdrawal Scale-Revised
10 weeks
Questionnaire of Smoking Urges- Brief (QSU-B )
10 weeks
- +5 more secondary outcomes
Study Arms (2)
Deep rTMS
ACTIVE COMPARATORDThe 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.
Precision TMS
EXPERIMENTALThe 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 DLPFC.
Interventions
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.
with a protocol of 5 seconds on, 10 seconds off, and a total of 3000 pulses/session, lasting 15 minutes, targeting the left DLPFC.
Eligibility Criteria
You may qualify if:
- Veteran
- Males and females between the ages of 18 and 70
- 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
You may not qualify if:
- Current moderate to severe substance use of any psychoactive substances other than nicotine or caffeine, as defined by DSM-V criteria
- Contraindications to MRI (e.g., metal in the skull, orbital or intracranial cavity, or claustrophobia)
- Contraindications to rTMS (history of a seizure or epilepsy)
- A history of autoimmune, endocrine, viral, or vascular disorders affecting the brain
- History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment
- Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea
- Major Axis I disorders diagnosed according to DSM-V criteria, such as bipolar affective disorder, schizophrenia, dementia, or major depression
- Regarding the Veteran population, we will enroll smokers who have PTSD
- Current use of other forms of nicotine delivery, such as nicotine patches or electronic cigarettes
- Currently prescribed bupropion and/or varenicline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703, United States
Related Publications (3)
Li X, Hartwell KJ, Henderson S, Badran BW, Brady KT, George MS. Two weeks of image-guided left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation improves smoking cessation: A double-blind, sham-controlled, randomized clinical trial. Brain Stimul. 2020 Sep-Oct;13(5):1271-1279. doi: 10.1016/j.brs.2020.06.007. Epub 2020 Jun 10.
PMID: 32534252BACKGROUNDLi X, Hartwell KJ, Owens M, Lematty T, Borckardt JJ, Hanlon CA, Brady KT, George MS. Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. Biol Psychiatry. 2013 Apr 15;73(8):714-20. doi: 10.1016/j.biopsych.2013.01.003. Epub 2013 Feb 26.
PMID: 23485014BACKGROUNDLi X, Toll BA, Carpenter MJ, Nietert PJ, Dancy M, George MS. Repetitive Transcranial Magnetic Stimulation for Tobacco Treatment in Cancer Patients: A Preliminary Report of a One-Week Treatment. J Smok Cessat. 2022 Jul 11;2022:2617146. doi: 10.1155/2022/2617146. eCollection 2022.
PMID: 35909440BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xingbao Li, MD
Ralph H. Johnson VA Medical Center, Charleston, SC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Single (Outcomes Assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2025
First Posted
July 3, 2025
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
April 30, 2030
Study Completion (Estimated)
August 31, 2030
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share