Optimizing TMS Pulse Protocols for Reward Processing in Smokers

Determining the Optimal Pulse Protocol for TMS Induced Change in Reward Positivity

This study is trying out different brain stimulation techniques to see if they can help smokers manage their cravings and make better decisions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Rutgers, The State University of New Jersey (other)
• Locations: 1 site (Newark, New Jersey)
• Trial ID: NCT06695884 on ClinicalTrials.gov

What this trial studies

This study aims to identify the most effective transcranial magnetic stimulation (TMS) pulse protocols to modulate reward activity in nicotine-dependent individuals. It will involve a randomized controlled design with two sessions, where participants will receive either excitatory or inhibitory TMS protocols while engaging in decision-making tasks. The study will also assess the impact of these protocols on craving levels and decision-making capacity. Participants will be required to abstain from smoking for four hours prior to each session to ensure accurate measurement of outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are nicotine-dependent individuals aged 18 to 55 who are in stable mental and physical health.

Not a fit: Patients with contraindications to MRI or rTMS, or those with a history of neurological disorders, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for nicotine use disorder by enhancing reward processing and decision-making in smokers.

How similar studies have performed: Other studies have shown promise in using TMS for modulating reward processing, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
2. 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).
3. History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
4. History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
5. Life time history of mental disorders such as: Bipolar Affective disorder (BPAD), Schizophrenia, Post-traumatic Stress disorder (PTSD) or Dementia or Major Depression.
6. uninterruptable central nervous system medication

Where this trial is running

Newark, New Jersey

• Rutgers University - Newark — Newark, New Jersey, United States (RECRUITING)

Study contacts

• Principal investigator: Travis E Baker, PhD — Rutgers University
• Study coordinator: Travis E Baker, PhD

Conditions: Nicotine Use Disorder, transcranial magnetic stimulation, reward processing, EEG, smoking