Recruiting

TMS

Sponsor:

Medical University of South Carolina

Code:

NCT04903028

Conditions

Tobacco Use

Cigarette Smoking

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Accepted

Interventions

Sham rTMS

Active rTMS 10 Hz DLPFC

Study Details

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.

Conditions

Tobacco Use

Cigarette Smoking

Study ID

NCT04903028

Start date

May 15, 2021

Status verified date

Apr, 2026

Completion date

Apr 4, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Accepted

Inclusion Criteria

  • Be between the ages of 22 and 70 years old.
  • Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level \> 10 ppm indicative of recent smoking.
  • Have not received substance abuse treatment within the previous 30 days.
  • Meet the criteria for tobacco use disorder as determined by DSM-5.
  • Be in stable mental and physical health.
  • If female, test non-pregnant and use adequate birth control.
  • Show no evidence of focal or diffuse brain lesions on MRI.
  • Be willing to provide informed consent.
  • Be able to comply with protocol requirements and likely to complete all study procedures.
  • Be 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., presence of metal in the skull, orbital or intracranial cavity, or having claustrophobia).
  • Contraindication to rTMS.
  • 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.
  • Lifetime history of major Axis I disorders such as: bipolar affective disorder (BPAD), schizophrenia, post-traumatic stress disorder (PTSD), dementia, suicidal ideation or major depression.
  • Self-report of \>21 standard alcohol drinks per week in any week in the 30 days prior to screening.
  • Use of other forms of nicotine delivery, such as nicotine patches, electronic cigarettes, gum, nasal spray, inhalers, and nicotine lozenges.
  • Use of other tobacco products, including cigars, cigarillos, chew, snuff, and pouches/snus.
  • Previous treatment with TMS.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: 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 comparator: 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.

Interventions

Sham rTMS

Two electrodes on the scalp will be connected to transcutaneous electrical nerve stimulation.

Active rTMS 10 Hz DLPFC

10 Hz repetitive transcranial magnetic stimulation (rTMS) will be delivered over left dorsolateral prefrontal cortex (DLPFC).

Primary outcome measure

  • 4 week continue quit rate [ Time Frame: 20 weeks ]
  • Task-functional connectivity from functional magnetic resonance imaging (fMRI) [ Time Frame: 4 week ]
  • Cigarette per day [ Time Frame: 20 weeks ]
  • Adverse Event [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Xingbao Li, MD, MSCR, MS

843-792-5729lixi@musc.edu

Rebecca Keneally

843-792-0136keneally@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Xingbao Li, M.D

843 7925729lixi@musc.edu

Principal Investigator:

Xingbao Li, M.D

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Xingbao Li, MD, MSCR, MS

843-792-5729lixi@musc.edu

Rebecca Keneally

843-792-0136keneally@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Tobacco use disorder, rTMS, 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 Medical University of South Carolina on 2026-04-16.