Skip to main content
Clinical Trials/NCT05766254
NCT05766254
Recruiting
Not Applicable

Identify the Optimal TMS Target to Modulate Midcingulate Reward Activity in Smokers

Rutgers, The State University of New Jersey1 site in 1 country36 target enrollmentMarch 24, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nicotine Use Disorder
Sponsor
Rutgers, The State University of New Jersey
Enrollment
36
Locations
1
Primary Endpoint
Event-related Brain Potential: Reward Positivity
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Detailed Description

The design is primarily a randomized control-trial design (3 sessions), comparing the effects 10-Hz rTMS applied to four prefrontal TMS targets based on fMRI, cortical thickness (CT), diffusion-weighted imaging (DWI) and resting state functional connectivity (RSFC) on reward processing across two groups of smokers - Active TMS group and Sham TMS group. For Session A, participants will be scanned using a 3 Tesla MRI system and will receive a structural (T1), fMRI, DWI, and resting-state FC scan. Following Session A, all participants will be asked to complete two Ri-TMS sessions within two weeks and will be instructed to abstain from smoking for 4 hours before the start of each scheduled session. Session B and C: Distinct prefrontal target regions will be identified for each subject based on CT, fMRI, DWI, and RSFC data. At the start of Session B, a target will be randomly assigned to each subject using a random permuted block method. For Sessions B and C, participants will be asked to provide their consent, CO levels, and complete the craving questionnaire (TCQ). At the start of Session B, participants will be fitted with an EEG cap and engage in a virtual T-maze feedback task. The task will be divided into two blocks (200 trials per block: 10 minutes per block). At the start of Block 1, the robotic arm will position the TMS coil \<1 cm over Target 1. Next, 50 rTMS pulses will be delivered at 110% of participants' rMT at 10- Hz continuously over Target 1 immediately before every 10 trials of the T-maze (5 seconds of TMS, 30 seconds of task). A total of 1000 pulses will be delivered to Target 1 and 200 T-maze trials completed (duration 10-15 minutes). Immediately after, subjects will be asked to complete a probabilistic selection task (PST) to measure post-stimulation effects on decision-making performance (duration, 15 minutes). Following the completion of the PST, subjects will be given a 5 minute rest-break and participants will be asked to fill out the TCQ. At the start of Block 2, the robotic arm will position the TMS coil \<1 cm over Target 2, and 50 rTMS pulses will be delivered immediately before every 10 trials of the T-maze task. A total of 1000 pulses will be delivered to Target 2 and 200 T-maze trials completed (duration 10 minutes). Following Target 2 stimulation, subjects will be asked to complete the PST (duration, 15 minutes) and asked to fill out the TCQ. At the end of the Session B, participants will be scheduled to return to the laboratory to complete Session C on a separate day. An identical protocol will be applied to Session C with the exception that TMS pulses will be deliver to Target 3 and Target 4.

Registry
clinicaltrials.gov
Start Date
March 24, 2023
End Date
September 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Travis Baker, PhD

Assistant Professor

Rutgers, The State University of New Jersey

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Event-related Brain Potential: Reward Positivity

Time Frame: Day 0 (day of testing)

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.

Secondary Outcomes

  • 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 Sites (1)

Loading locations...

Similar Trials