Identify the Optimal TMS Target to Modulate Reward Activity

Part of paid clinical trials in Newark, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05766254
Status
Recruiting
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Conditions

  • Nicotine Use Disorder

Eligibility Criteria

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

Interventions

  • Active 10-Hz TMS to the DLPFC — 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 — 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

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.

Key Dates

Start date
Mar 24, 2023
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

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

Arms

  • Experimental: Active TMS
    Participants in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined prefrontal target for a total of 1000 pulses. Within each of the two TMS sessions, two targets will be stimulated.
  • Sham Comparator: Sham TMS
    Identical parameters will be applied to the SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation.

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
Nicole Lalta
[email protected]
973-353-3509

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By research site
Rutgers University - Newark· Newark, NJ

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