Causal Role of Frontostriatal Circuitry in Goal-directed Behavior

NCT05593965 | Completed Results FDA Device

• 2 other identifiers: 22-24301K99MH126161-01A1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to investigate the causal role that frontostriatal circuitry plays in goal-directed behavior. The participants will perform a reward-based decision-making task. During the task, cross-frequency patterned rhythmic transcranial magnetic stimulation (TMS) will be delivered at delta-beta frequency, a control-frequency, or an active sham to either the dorsolateral or medial prefrontal cortex (PFC). Electroencephalography will be collected concurrent with stimulation. Structural and functional magnetic resonance imaging (MRI) will be collected during performance of the reward-based decision-making task to localize the stimulation targets.

Conditions

Executive Function

Outcome Measures

Primary Outcomes (1)

• Percentage of the Trials That the Participant Chooses to Perform the Hard Task

  In the Expenditure of Effort for Reward Task, participants are faced with a decision on every trial: to choose an easy task with a low effort exertion for a chance at winning a low amount of money and a hard task with a high effort exertion for a chance at winning a greater amount of money. The incentive for the high effort exertion is changed on each trial and the participant gets physically tired from repeated effort exertion. Goal-directed behavior was calculated as the percentage of trials in which the participant decides to perform the most difficult effort exertion task in the Expenditure of Effort for Reward Task. A higher percentage equates to more goal-directed behavior and is favorable.

  2 hours during the 1st intervention and 2 hours during the 2nd intervention

Secondary Outcomes (1)

• Coupling Strength Between Low-frequency Prefrontal Signals and High-frequency Posterior Signals

  2 hours during the 1st intervention and 2 hours during the 2nd intervention

Study Arms (2)

TMS to lateral prefrontal cortex followed by TMS to medial prefrontal cortex

EXPERIMENTAL

Participants will receive TMS while performing a reward-based decision-making task. In the first stimulation session, the TMS coil will be placed over the lateral prefrontal cortex on the scalp. In the second session, the TMS coil will be placed over the medial prefrontal cortex on the scalp. during every session, subjects receive Delta-beta patterned TMS, Theta-gamma patterned TMS, and Arrhythmic TMS.

Device: Delta-beta TMS; Device: Theta-gamma TMS; Device: Arrhythmic TMS

TMS to medial prefrontal cortex followed by TMS to lateral prefrontal cortex

EXPERIMENTAL

Participants will receive TMS while performing a reward-based decision-making task. In the first stimulation session, the TMS coil will be placed over the medial prefrontal cortex on the scalp. In the second session, the TMS coil will be placed over the lateral prefrontal cortex on the scalp. during every session, subjects receive Delta-beta patterned TMS, Theta-gamma patterned TMS, and Arrhythmic TMS.

Device: Delta-beta TMS; Device: Theta-gamma TMS; Device: Arrhythmic TMS

Interventions

Delta-beta TMS DEVICE

TMS will be delivered in a delta-beta pattern in which triplets of pulses delivered at 20 Hz (50 milliseconds between each pulse) are sent every 3 Hz (333 milliseconds between the start of each triplet).

TMS to lateral prefrontal cortex followed by TMS to medial prefrontal cortex; TMS to medial prefrontal cortex followed by TMS to lateral prefrontal cortex

Theta-gamma TMS DEVICE

TMS will be delivered in a theta-gamma pattern in which triplets of pulses delivered at 50 Hz (20 milliseconds between each pulse) are sent every 5 Hz (200 milliseconds between the start of each triplet).

TMS to lateral prefrontal cortex followed by TMS to medial prefrontal cortex; TMS to medial prefrontal cortex followed by TMS to lateral prefrontal cortex

Arrhythmic TMS DEVICE

TMS will be delivered in an arrhythmic pattern in which pulses are delivered with a random inter-pulse interval. The number of pulses and duration is matched to that of the Delta-beta TMS and Theta-gamma TMS.

TMS to lateral prefrontal cortex followed by TMS to medial prefrontal cortex; TMS to medial prefrontal cortex followed by TMS to lateral prefrontal cortex

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Between the ages of 18 and 35
• Right handed
• Able to provide informed consent
• Willing to comply with all study procedures
• Available for the duration of the study
• Speak and understand English.

You may not qualify if:

• Attention Deficit Hyperactivity Disorder (currently under treatment)
• Neurological disorders and conditions, including, but not limited to: History of epilepsy Seizures (except childhood febrile seizures)
• Dementia
• History of stroke
• Parkinson's disease
• Multiple sclerosis
• Cerebral aneurysm
• Brain tumors
• Medical or neurological illness or treatment for a medical disorder that could interfere with study participation (e.g., unstable cardiac disease, human immunodeficiency virus or acquired immunodeficiency syndrome, malignancy, liver or renal impairment)
• Prior brain surgery
• Any brain devices/implants, including cochlear implants and aneurysm clips
• Cardiac pacemaker
• Any other implanted electronic device
• History of current traumatic brain injury
• (For females) Pregnancy or breast feeding

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Results Point of Contact

• Title: Justin Riddle, PhD
• Organization: University of North Carolina at Chapel Hill

justin_riddle@med.unc.edu

(919) 966-4584

Study Officials

• Flavio Frohlich, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: January 10, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 17, 2024
• Results First Posted: July 17, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 9 months and continuing for 36 months following publication
• Access Criteria: Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board, Independent Ethics Committee, or Research Ethics Board and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill.

Locations

US (1)