Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06323057
Other study ID # Pro2022000444_CLFMT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 14, 2024
Est. completion date April 30, 2025

Study information

Verified date March 2024
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Our specific aim is to examine the effects of TMS on reward processing during goal-directed behavior. In these experiments the investigators will utilize a scalp-recorded brain oscillation called frontal midline theta that is believed to index the sensitivity of the cingulate cortex to reward feedback. Here the investigators will asked whether this electrophysiological signal can be modulated up or down using TMS while participants engage in decision making tasks, and if so, whether it would affect the encoding of rewards and subsequent choices during task performance.


Description:

The design is primarily a randomized control-trial design (2 sessions), testing the effects of single-pulse TMS on reward processing during goal-directed behavior tasks. Subjects will be randomly assigned to an peak or trough group. All participants will be asked to complete two TMS sessions within two weeks. For each TMS session, participants will receive either Active TMS or Sham TMS. For each TMS session, the TMS coil will be placed 1cm above the scalp over a left frontal region (electrode location F3). Subjects will be randomly assigned to an active or sham condition for each session. At the start of the first TMS session, participants will be fitted with an EEG cap and engage in a virtual T-maze reward task. The T-maze task will be divided into 30 blocks of trials. For the first block of 10 trials, a single TMS pulse will be delivered over the DLPFC immediately following trial-to-trial feedback and at the desired theta phase. Reward stimulus (apple or orange) will indicate whether the participant will receive 5 or 0 cents on that trial. Immediately following this block, subjects will complete 5 trials with no modulation. This block sequence will repeat for 30 blocks for a total of 300 pulses delivered and 450 T-maze trials completed (duration 15 minutes: 300 TMS trials, 150 no-TMS trials). TMS pulse delivery will be open for 1 second and only 1 pulse will be delivered within this time range. Following the T-maze, participants will engage in the probabilistic selection task. During the learning phase of the PST, subjects will again receive a single TMS pulse at the desired theta phase following feedback onset. A total of 240 pulses will be delivered and 240 learning phase trials will be completed before subjects perform the test phase (duration 15-20 minutes). Identical protocol will be applied to the second Sham session (1-week later). Participants will be debriefed and compensated for their participation.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Be between the ages of 18 and 55 years old. - Be in stable mental and physical health. - If female, test non-pregnant. - Be willing to provide informed consent. - Be able to comply with protocol requirements and likely to complete all study procedures. Exclusion Criteria: - 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. - Life time history of mental disorders such as: Bipolar Affective disorder (BPAD), Schizophrenia, Post-traumatic Stress disorder (PTSD) or Dementia or Major Depression. - uninterruptable central nervous system medication

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Single pulse TMS to the frontal cortex
Single pulse TMS will be delivered to the left frontal cortex, and stimulation intensity will be at 110% of resting motor threshold.

Locations

Country Name City State
United States Rutgers University - Newark Newark New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Event-related Brain Oscillation: Frontal Midline Theta Frontal-midline theta (FMT: 4-8 hz) is a scalp recorded brain oscillation sensitive to the processing of reward stimulus presented during decision making tasks. FMT will be measured during the presentation of the reward stimulus (Reward, No-reward) during task performance. A time-frequency analysis will be used to measure FMT power for each electrode by averaging the single-trial EEG according to feedback type (reward and no-reward). The size of the FMT will be determined by identifying the maximum amplitude of the FMT response and evaluated at frontal electrodes. The FMT will be measured for each proposed phase target group across active and sham conditions, and used to measure the efficacy of the TMS target to modulate brain activity associated with reward processing. [Time Frame: Day 0 (day of testing)]
Primary Reward learning Decision making behavioral measures of interest consist of learning and test phase accuracy, reaction time, and post-error reaction time (?RT, subsequent negative feedback trial RT minus the current trial RT, with higher values reflecting greater adaption or slowing). [Time Frame: Day 0 (day of testing)]
See also
  Status Clinical Trial Phase
Completed NCT04612842 - Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI) N/A
Active, not recruiting NCT05516264 - Behavioural and Physiological Responses to Dog Visits in Nursing Homes N/A
Completed NCT05152342 - Reducing Stigma Among Individuals With Addiction and Staff in the Criminal Justice System N/A
Enrolling by invitation NCT05092100 - Neural Mechanisms for Reducing Interference During Episodic Memory Formation N/A
Completed NCT03216213 - Evaluating Attitudes Towards Organ Donation in Singapore N/A
Completed NCT04656574 - The Effects of Sımulatıon Used in Vagınal Chıldbırth on Malpractıce Tendency And Perceptıons of Care Behavıors N/A
Enrolling by invitation NCT05319821 - PA Moves Trial - PCP Participants N/A
Not yet recruiting NCT03266666 - Welcome to WellnessRX: Steps Toward a Healthier Life! N/A
Completed NCT03003923 - Promoting Vegetable Intake in Preschool Aged Children N/A
Completed NCT02267265 - Pilot Study of Novel Postpartum Educational Video Intervention N/A
Completed NCT01629069 - A Transplant or Cancer Resilience Intervention N/A
Completed NCT02934165 - Safety Skills Training For Parents of Preschool Children N/A
Completed NCT01945645 - Ready to Act - Health Education in People With Hyperglycaemia N/A
Completed NCT00056940 - Prevention of Violent Behavior Among Children N/A
Recruiting NCT03912597 - VR-assisted Curriculum on Depression for Stigma Reduction N/A
Completed NCT04525703 - Pathways for Parents After Incarceration Feasibility Study N/A
Completed NCT06217289 - A Study on Behavior of Healthcare Professionals Who Handle Oral Solid Drug
Completed NCT04078633 - Innovative Hand Washing Interventions for Internally Displaced Populations in Ethiopia N/A
Completed NCT03687658 - Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating N/A
Completed NCT04826276 - Effects of Smoking State on Decision Making N/A