Identify the Optimal TMS Target to Modulate Reward Activity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorRutgers, The State University of New Jersey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Active TMSExperimental treatment 1 intervention
Group B: Sham TMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Event-related Brain Potential: Reward Positivity

The reward positivity is an event-related brain potential (ERP) sensitive to reward feedback. The reward positivity will be measured during the T-maze task, where participants will receive feedback (Reward, No-reward) following choices. ERPs will be created for each electrode and participant by averaging the single-trial EEG according to feedback type (Reward, No-reward). The reward positivity will be evaluated by subtracting the Reward feedback ERPs from the corresponding No-reward feedback ERPs. The size of the reward positivity will then be determined by identifying the maximum absolute amplitude of the difference wave within a 200-to 400-msec window after feedback onset and evaluated along electrodes Fz, FCz, and Cz. The reward positivity will be measured for each proposed DLPFC target across active and sham groups of dependent smokers. The reward positivity will be used to measure the efficacy of the DLPFC target to modulate reward activity.

Time frame
Day 0 (day of testing)

Secondary outcomes

1

Approach Learning

Approach learning will be measured using a Probabilistic Selection task (PST), in which subjects are shown pairs of arbitrary stimuli and must learn by trial-and-error to select one of each pair. During an initial learning phase participants are exposed to three pairs of stimuli, each of the three pairs is rewarded on 80%, 70%, and 60% of the trials. Subjects learn by feedback that some stimuli are associated with more positive feedback (Approach) and that some stimuli are associated with more negative feedback (Avoidance). To determine whether subjects learn more from positive (approach) or negative (avoidance) feedback, during a subsequent testing phase they are required to choose between novel stimulus pairs. Approach learning (accuracy and reaction time) for each proposed DLPFC target across active and sham groups will be measured during the testing phase. Avoidance learning performance will be used to measure the efficacy of the DLPFC target to modulate decision making.

Time frame
Day 0 (day of testing)
2

Avoidance Learning

Avoidance learning will be measured using a Probabilistic Selection task (PST), in which subjects are shown pairs of arbitrary stimuli and must learn by trial-and-error to select one of each pair. During an initial learning phase participants are exposed to three pairs of stimuli, each of the three pairs is rewarded on 80%, 70%, and 60% of the trials. Subjects learn by feedback that some stimuli are associated with more positive feedback (Approach) and that some stimuli are associated with more negative feedback (Avoidance). To determine whether subjects learn more from positive (approach) or negative (avoidance) feedback, during a subsequent testing phase they are required to choose between novel stimulus pairs. Avoidance learning (accuracy and reaction time) for each proposed DLPFC target across active and sham groups will be measured during the testing phase. Avoidance learning performance will be used to measure the efficacy of the DLPFC target to modulate decision making.

Time frame
Day 0 (day of testing)
3

Nicotine Craving

The level of craving will be assessed in dependent smokers using the short version of the Tobacco Craving Questionnaire (TCQ), a 12-item scale that assesses state levels of craving. TCQ will be measured at the start of each session, and following each Block of TMS (once for each DLPFC target). We will compared the TCQ score from pre-TMS (start of session) to post-TMS.

Time frame
Day 0 (day of testing - before and after TMS)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.