Identify the Optimal TMS Pulse Protocol to Modulate Reward Activity

Last updated: November 15, 2024
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tobacco Use Disorder

Stimulant Use Disorder

Treatment

Transcranial Magnetic Stimulation

Clinical Study ID

NCT06695884
Pro2022000444_TBSrTMS
  • Ages 18-55
  • All Genders

Study Summary

Our 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. Our secondary objective will be to measure the protocols' 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 2 sessions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Nicotine dependent individuals (according to the Alcohol, Smoking and SubstanceInvolvement 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 studyprocedures.

Exclusion

Exclusion Criteria:

  1. Contraindication to MRI (e.g., presence of metal in the skull, orbits orintracranial cavity, claustrophobia).

  2. Contraindication to rTMS (history of neurological disorder or seizure, increasedintracranial 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 diffusebrain 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 MajorDepression.

  6. uninterruptable central nervous system medication

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: Transcranial Magnetic Stimulation
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
August 31, 2025

Study Description

The design is primarily a randomized control-trial design (2 sessions), comparing the effects excitatory and inhibitory TMS protocols applied to a prefrontal TMS target on reward processing in smokers. Eligible smokers will be invited to attend two experimental sessions over a 1-month period, and asked to abstain from smoking 4 hrs prior to each session. For Sessions A and B, participants will be asked to provide their consent, CO levels and complete the TCQ. Compliance with the 4-hour abstinence period will be defined as breath CO less than 13 ppm. Participants will then be randomly selected to participate in Condition 1a or Condition 1b. All procedures between the two conditions will be identical except for the contrasting TMS protocols (Condition 1a: excitatory protocols, Condition 1b: inhibitory protocols) and the rewards presented in the T-maze task (Condition 1a: monetary rewards, Condition 1b: monetary rewards with cigarette cues). To streamline these studies, the left DLPFC target will be based on conventional DLPFC targeting methods (electrode position F3). For Condition 1a, the protocol administered in Session A and B will be randomized so that participants will either receive 3600 pulses of 10-Hz TMS or 3600 pulses of cTBS. For each session, participants will first engage in one block of T-maze trials (100 trials: Baseline measure). In Condition 1a, participants are told that the reward stimulus indicated 5 cents and that the presentation of the no-reward stimulus indicated the alley was empty (0 cents). Following this block of trials, participants will either receive 10-Hz TMS or cTBS over the predefined DLPFC target (F3), and then asked to complete 3 additional Blocks of the T-maze (300 trials: post-TMS). Immediately after participants complete the T-maze, subjects will be asked to complete the PST and TCQ. At the end of the Session A, participants will complete Session B on a separate day (all procedures identical as Session A). Session A and Session B will be separated by at least 2 days to minimize carryover effects. For Condition 1b, the protocol administered in Session A and B will be randomized so that participants will either receive 600 or 1200 pulses of iTBS. For each session, participants will first engage in one block of T-maze trials (100 trials: Baseline). In Condition 1b, participants are told that the reward stimulus indicated 5 cents and that the presentation of the no-reward stimulus indicated the alley was empty (0 cents). Each reward and no-reward stimulus will be paired with a cigarette cue. Following this block of trials, participants will either receive 600 or 1200 pulses of iTBS over the predefined DLPFC target (electrode F3), and then asked to complete 3 additional Blocks of the T-maze (300 trials: Post-TMS). Immediately after participants complete the T-maze, subjects will be asked to complete the PST and the TCQ. At the end of the Session A, participants will complete Session B on a separate day (all procedures identical as Session A). Session A and Session B will be separated by at least 2 days to minimize carryover effects.

Connect with a study center

  • Rutgers University - Newark

    Newark, New Jersey 07102
    United States

    Active - Recruiting

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