Identify the Optimal TMS Pulse Protocol to Modulate Reward Activity

NCT06695884 | Recruiting FDA Device

• 1 other identifier: Pro2022000444_TBSrTMS
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal will be to identify the optimal pulse protocol by systematically measuring the efficacy of various theta burst stimulation and repetitive rTMS protocols to increase and decrease the reward positivity in dependent smokers. The secondary objective will be to measure the protocols' effectiveness to increase decision-making capacity using the probabilistic selection task (PST). The 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 \[TCQ\]. The investigators plan to accomplish these three objectives using a randomized, controlled experiment involving 2 sessions.

Conditions

Nicotine Use Disorder

Keywords

transcranial magnetic stimulation; reward processing; EEG; smoking

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 pulse protocol across condition 1a and condition 1b of dependent smokers. The reward positivity will be used to measure the efficacy of the pulse protocol to modulate reward activity.

  Day 0 (day of testing)

Secondary Outcomes (1)

• Approach Learning

  Day 0 (day of testing)

Other Outcomes (1)

• Nicotine Craving

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

Study Arms (2)

Excitatory TMS

EXPERIMENTAL

For condition 1a, 3600 pulses of 10-Hz TMS or 3600 pulses of cTBS. 10 Hz rTMS (110% RMT stimulation intensity; 10 Hz frequency; 5 s on and 26 s off; 3600 pulses per session; total duration of 40 min). cTBS (80% RMT, (3 pulses at 50 Hz with a repeated frequency of 5 Hz, 200 ms intervals, containing 1800 pulses, 60 second break, 1800 pulses; total duration of 5 minutes).

Device: Transcranial Magnetic Stimulation

Inhibitory TMS

EXPERIMENTAL

For condition 1b, 600 or 1200 pulses of iTBS. iTBS will be administered at 80% of each participant's RMT in a burst-firing pattern (3 pulses at 50 Hz) for a 2 s train, followed by an 8 s period of rest. Across sessions, participants will receive one of two iTBS protocols (randomized): 600 pulses (190 s) or 1200 pulses (570 s).

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

TMS will be delivered using a robotic neuronavigation system (Smartmove, ANT). Stimulation intensity will be standardized. Stimulation will be delivered to the L-DLPFC using a active/placebo figure-8 coil and a magventure TMS device.

Excitatory TMS; Inhibitory 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; Smoking

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Travis E Baker, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Travis E Baker, PhD

CONTACT

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

Emily Zhang

CONTACT

973-353-3509; travis.e.baker@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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)