What this study is
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.
What's being tested
- Active 10-Hz TMS to the DLPFC
Intervention · 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.
- Sham TMS-DLPFC
Intervention · 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.
Study details
- Official title
- Identify the Optimal TMS Target to Modulate Midcingulate Reward Activity in Smokers
- Sponsor
- Rutgers, The State University of New Jersey
- Conditions
- Nicotine Use Disorder
- Enrolling
- 36 people
- Starts
- 2023-03-24
- Est. completion
- 2026-09
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 55 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openRutgers University - Newark
Newark, New Jersey, United States
- Travis E Baker, PhD · Contact973-353-5485travis.e.baker@rutgers.edu
- Nicole Lalta · Contact973-353-3509nicole.lalta@rutgers.edu
Recruiting
Study team
Sponsor
Rutgers, The State University of New Jersey
Study ID Pro2022000444
Principal investigator
Travis E Lalta, PhD
Rutgers University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.