Identify the Optimal TMS Target to Modulate Reward Activity

NCT05766254 | Recruiting DMC FDA Device

• 1 other identifier: Pro2022000444
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Our primary goal will be to identify the optimal prefrontal-cingulate target by systematically measuring the efficacy of various image-based targeting techniques to increase the reward positivity using the 10-Hz TMS protocol in dependent smokers. Our secondary objective will be to measure the targets' effectiveness to increase decision-making capacity using the probabilistic selection task (PST). Our third objective will be to specifically assess whether the TMS targets has a differential impact on state levels of craving relative to baseline (Tobacco Craving Questionnaire \[TCQ\]. We plan to accomplish these three objectives using a randomized, controlled experiment involving 3 sessions.

Conditions

Nicotine Use Disorder

Keywords

transcranial magnetic stimulation; reward processing; EEG; neuroimaging

Outcome Measures

Primary Outcomes (1)

• Event-related Brain Potential: Reward Positivity

  The reward positivity is an event-related brain potential (ERP) sensitive to reward feedback. The reward positivity will be measured during the T-maze task, where participants will receive feedback (Reward, No-reward) following choices. ERPs will be created for each electrode and participant by averaging the single-trial EEG according to feedback type (Reward, No-reward). The reward positivity will be evaluated by subtracting the Reward feedback ERPs from the corresponding No-reward feedback ERPs. The size of the reward positivity will then be determined by identifying the maximum absolute amplitude of the difference wave within a 200-to 400-msec window after feedback onset and evaluated along electrodes Fz, FCz, and Cz. The reward positivity will be measured for each proposed DLPFC target across active and sham groups of dependent smokers. The reward positivity will be used to measure the efficacy of the DLPFC target to modulate reward activity.

  Day 0 (day of testing)

Secondary Outcomes (3)

• Approach Learning

  Day 0 (day of testing)

• Avoidance Learning

  Day 0 (day of testing)

• Nicotine Craving

  Day 0 (day of testing - before and after TMS)

Study Arms (2)

Active TMS

EXPERIMENTAL

Participants in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined prefrontal target for a total of 1000 pulses. Within each of the two TMS sessions, two targets will be stimulated.

Device: Active 10-Hz TMS to the DLPFC

Sham TMS

SHAM COMPARATOR

Identical parameters will be applied to the SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation.

Device: Sham TMS-DLPFC

Interventions

Active 10-Hz TMS to the DLPFC DEVICE

The active group will receive 10hz TMS stimulation. Participants in the active stimulation group will receive10-Hz TMS to left DLPFC. The LDLPFC will be based on 4 targeting neuroimaging methods (cortical thickness, fMRI, diffusion imaging, functional connectivity). TMS will be delivered using a robotic neuronavigation system (Smartmove, ANT). Stimulation intensity will be standardized at 110% of RMT and adjusted to the skull to cortical surface based on e-field calculations (simnibs). Stimulation will be delivered to the L-DLPFC using a active/placebo figure-8 coil and a magventure TMS device.

Active TMS

Sham TMS-DLPFC DEVICE

The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.

Sham TMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Nicotine dependent individuals (according to the Alcohol, Smoking and Substance Involvement Screening Test nicotine dependence score).
• Be between the ages of 18 and 55 years old.
• Not received substance abuse treatment within the previous 30 days.
• Be in stable mental and physical health.
• If female, test non-pregnant.
• No evidence of focal or diffuse brain lesion on MRI.
• Be willing to provide informed consent.
• Be able to comply with protocol requirements and likely to complete all study procedures.

You may not qualify if:

• Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
• Contraindication to rTMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \> 15 minutes, implanted electronic device, metal in the head, or pregnancy).
• History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
• History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
• Life time history of mental disorders such as: Bipolar Affective disorder (BPAD), Schizophrenia, Post-traumatic Stress disorder (PTSD) or Dementia or Major Depression.
• uninterruptable central nervous system medication

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University - Newark

Newark, New Jersey, 07102, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Travis E Lalta, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Travis E Baker, PhD

CONTACT

973-353-5485; travis.e.baker@rutgers.edu

Nicole Lalta

CONTACT

973-353-3509; nicole.lalta@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant) Participants will be blinded as to TMS condition (active or sham)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 13, 2023
• Study Start: March 24, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)