Identify the Optimal TMS Pulse Protocol to Modulate Reward Activity

Part of paid clinical trials in Newark, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06695884
Status
Recruiting
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Conditions

  • Nicotine Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Excitatory TMS
    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).
  • Experimental: Inhibitory TMS
    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).

Primary Outcome Measure

Event-related Brain Potential: Reward Positivity [ Time Frame: Day 0 (day of testing) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers University - NewarkNewarkNew Jersey07102
Travis E Baker, PhD
[email protected]
973-353-5485

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By research site
Rutgers University - Newark· Newark, NJ

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