Recruiting

Personalized TMS vs. Standard TMSModulating Neural Mechanisms of Reward Processing in Tobacco Users

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07812753

Conditions

Tobacco Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

PRIME TMS

Standard TMS

Study Details

Brief summary:

The goal of this clinical trial is to learn if a personalized, brain-scan-guided form of transcranial magnetic stimulation (TMS) works better than a standard TMS approach at changing reward-related brain activity in adults who smoke cigarettes. The main questions it aims to answer are:

Does personalized TMS produce a greater change in reward-related brain activity than the standard approach? Does personalized TMS lead to a greater reduction in cravings and cigarette smoking than the standard approach?

Researchers will compare personalized TMS, which targets a treatment location chosen from each participant's own brain scan, to a standard TMS approach, which targets a location based on anatomical landmarks, to see if the personalized approach produces stronger effects on brain reward activity and smoking behavior.

Participants will:

Complete an magnetic resonance imaging (MRI) brain scan and questionnaires about their smoking habits and mood Be randomly assigned to receive either personalized TMS or the standard TMS approach Attend 15 TMS treatment sessions over 3 weeks (Monday through Friday), including brain wave (EEG) recordings and craving check-ins before and after each session Return for follow-up visits 1 week and 1 month after finishing treatment

Conditions

Tobacco Use Disorder

Study ID

NCT07812753

Start date

Jul 24, 2026

Status verified date

Sep, 2026

Completion date

Jul 15, 2029

Anticipated

Primary completion date

Jul 15, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

Be between the ages of 18 and 60 years old
Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level greater than 10 ppm indicative of recent smoking
Have not received substance abuse treatment within the previous 30 days
Meet criteria for Tobacco Use Disorder as determined by the Mini International Neuropsychiatric Interview (MINI): meeting 4 or more of the 11 diagnostic symptoms of Tobacco Use Disorder within a 12-month period
If female, test non-pregnant
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 a response of "very likely" or "somewhat likely" on the Motivation to Stop Scale (scores 4-7)

Exclusion Criteria:

Meeting MINI diagnostic criteria for any non-tobacco substance use disorder other than Caffeine Use Disorder, Cannabis Use Disorder - Mild, or Alcohol Use Disorder - Mild (Mild defined as meeting 2 to 3 of the 11 diagnostic symptoms within a 12-month period)
Contraindications to MRI (e.g., metal in the skull, orbital, or intracranial cavity, or claustrophobia)
Contraindication to repetitive TMS
History of autoimmune, endocrine, viral, or vascular disorders affecting the brain
History or MRI evidence of a neurological disorder causing 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 as confirmed by the MINI, including bipolar affective disorder, schizophrenia, post-traumatic stress disorder, suicidal ideation, or major depression
Current use of tobacco cessation pharmacotherapies, including nicotine patches, electronic cigarettes, gum, nasal spray, inhalers, nicotine lozenges, varenicline, or bupropion
Previous treatment with TMS

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: PRIME TMS (Personalized Connectivity-Based Targeting)

Participants receive 15 sessions of 10 Hz repetitive TMS over 3 weeks (Monday-Friday), delivered at 110% of resting motor threshold. The stimulation target is an individualized dorsolateral prefrontal cortex location identified from each participant's diffusion-weighted MRI as having maximal structural connectivity to the midcingulate cortex. Stimulation is delivered concurrently with a brief reward-based cognitive task performed during inter-train intervals, intended to engage the brain's reward circuitry during treatment.

active comparator: Standard TMS (Anatomical Targeting)

Participants receive 15 sessions of 10 Hz repetitive TMS over 3 weeks (Monday-Friday), delivered at 110% of resting motor threshold. The stimulation target is a dorsolateral prefrontal cortex location identified using standardized anatomical landmarks on structural MRI, without individualized connectivity mapping. Stimulation is delivered without a concurrent cognitive task. This approach reflects a well-established TMS protocol with a long-standing published safety and efficacy record.

Interventions

PRIME TMS

Repetitive TMS (10 Hz, 3,000 pulses per session, 110% resting motor threshold) delivered via a figure-8 coil using robotic neuronavigation. The stimulation target is an individualized dorsolateral prefrontal cortex location identified from each participant's diffusion-weighted MRI as having maximal structural connectivity to the midcingulate cortex. Delivered over 15 sessions across 3 weeks, concurrently with a brief reward-based cognitive task performed during inter-train intervals.

Standard TMS

Repetitive transcranial magnetic stimulation (10 Hz, 3,000 pulses per session, 110% resting motor threshold) delivered via a figure-8 coil using robotic neuronavigation. The stimulation target is a dorsolateral prefrontal cortex location identified using standardized anatomical landmarks on structural MRI, without individualized connectivity mapping. Delivered over 15 sessions across 3 weeks, without a concurrent cognitive task.

Primary outcome measure

Change in Reward Positivity Amplitude [ Time Frame: Baseline (Day 1, prior to Session 1) and Day 19 (within 3 days following completion of the 15-TMS sessions course), approximately Weeks 1 and 6 ]

Central Contacts and Locations

Central contacts

TRAVIS BAKER, PhD

9733533385 travis.e.baker@rutgers.edu

Locations

Rutgers University Center for Molecular and Behavioral Neuroscience

Recruiting

Newark, New Jersey, United States, 07102

Contacts

Travis Baker, PhD

9733533385 travis.e.baker@rutgers.edu

travis.e.baker@rutgers.edu

Principal Investigator:

Travis E Baker, PhD

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Keywords

Transcranial magnetic stimulation
Tobacco use disorder
Smoking cessation
reward processing
brain connectivity
Electroencephalography
Neuromodulation
Craving

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-09-10.