Modulating Neural Mechanisms of Reward Processing in Tobacco Users

Conditions

• Tobacco Use Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• PRIME TMS — DEVICE
  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 — DEVICE
  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.

Study Details

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

Key Dates

First listed

Sep 10, 2026

Start date

Jul 24, 2026

Status verified

Sep 2026

Primary completion

Jul 15, 2029

Completion

Jul 15, 2029

Study Design

Enrollment

54 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

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.

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

• TRAVIS BAKER, PhD
  9733533385
  [email protected]

Locations (1)

Find similar trials in Newark, NJ

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