Recruiting

TMS vs. rTMS

Sponsor:

VA Office of Research and Development

Code:

NCT07050862

Conditions

Tabacco Use Disorder

rTMS

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Personalized-image-guided and E-field-modeling dose rTMS (precision TMS)

Study Details

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.

Conditions

Tabacco Use Disorder

rTMS

Study ID

NCT07050862

Start date

Jul 1, 2026

Status verified date

Jul, 2026

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Apr 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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, the investigators 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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

Transcranial Magnetic Stimulation

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.

Personalized-image-guided and E-field-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.

Primary outcome measure

  • Cigarettes per day (CPD) [ Time Frame: The cigarettes per day will be measured up to 3 weeks for the outcome 1 ]
  • Brain Imaging Outcomes - Cue Craving Scans [ Time Frame: 3-weeks ]

Central Contacts and Locations

Central contacts

Xingbao Li, MD MS

(843) 577-5011xingbao.li@va.gov

Aimee L Mcrae-Clark, PharmD

(843) 792-5216Aimee.McRae-Clark@va.gov

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Recruiting

Charleston, South Carolina, United States, 29401-5703

Contacts

R. Amanda C LaRue, PhD

(843) 789-6707Rutha.Larue@va.gov

Sarah A Jackson, BA MA

(843) 789-6700sarah.jackson@va.gov

Principal Investigator:

Xingbao Li, MD MS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

  • Tabacco use disorder
  • Veterans
  • Transcranial Magnetic Stimulation
  • Smoking Cessation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-04.