MPFC Theta Burst Stimulation as a Tool to Affect Rational Decision Making

NCT ID: NCT05917002

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-08-01

Brief Summary

This is a study to investigate if a device that temporarily changes brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how healthy participants make decisions. This study involves 2 visits to MUSC that will each take between 2-3 hours. This study is not a treatment study, but it could help inform studies investigating treatment in the future. Participants in this study will be compensated for their time.

Detailed Description

This study aims to investigate whether a single session of excitatory repetitive transcranial magnetic stimulation (rTMS) compared to electrical sham stimulation to the medial prefrontal cortex (mPFC) facilitates rational decision making. Our prior data suggests that decisions are biased depending on if the available options are presented with a negative or positive connotation (even in the case of mathematical equivalence). Work by us and others has demonstrated that even if both options are equal, the negatively framed choice is most often avoided.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Real TBS to the mPFC

The type of stimulation to be used will be intermittent theta burst (iTBS) stimulation to the mPFC with a figure 8 coil (Coil Cool-B65 A/P). Participants will receive three 3-minute sessions of iTBS (600 pulses; 190s; 120% resting motor threshold) with 10-15-minute breaks in between each session or more per participant preference.

Group Type: EXPERIMENTAL

Real TBS to mPFC

Intervention Type: DEVICE

This will be delivered with the Magventure MagPro System; (double blinded using the integrated active sham system).

Sham TBS to the mPFC

The MagVenture MagPro system has an integrated, active sham which passes current through two surface electrodes placed on the scalp. The electrodes will be placed on the left frontalis muscle for all sessions. A patient identification card will randomize participants to receive either sham or active stimulation in the first session.This system maintains blinding by a gyroscope in the coil which indicates to the clinical staff whether the coil should be rotated up or down for this participant once the card is entered into the machine. One side of the coil is active, the other is sham. The integrity of the double blind procedure will be assessed by asking the patients and study personnel rate their confidence regarding whether they thought they received real or sham. (Scale 1-10)

Group Type: SHAM_COMPARATOR

Sham TBS to mPFC

Intervention Type: DEVICE

This will be delivered with the Magventure MagPro System; (double blinded using the integrated active sham system). The Magventure MagPro system has an integrated active sham that passes current through two surface electrodes placed on the scalp. The electrodes are placed on the left frontalis muscle under the coil for both the real and sham stimulation sessions.

Interventions

Real TBS to mPFC

This will be delivered with the Magventure MagPro System; (double blinded using the integrated active sham system).

Intervention Type: DEVICE

Sham TBS to mPFC

This will be delivered with the Magventure MagPro System; (double blinded using the integrated active sham system). The Magventure MagPro system has an integrated active sham that passes current through two surface electrodes placed on the scalp. The electrodes are placed on the left frontalis muscle under the coil for both the real and sham stimulation sessions.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Is able to read consent document and provide informed consent
• English is first or primary language

Exclusion Criteria

• • Current psychiatric disorder (as defined by DSM-5 and determined using standardized self-report instruments)

• Suicide attempt in the past year
• Lifetime diagnosis of psychotic disorder or bipolar mania
• Presence of neurological disorder that contraindicates TMS or neurophysiological recording:
• Seizure disorder
• Lifetime history of traumatic brain injury with loss of consciousness
• Neurodegenerative disorder (e.g., Alzheimer's Disease, Parkinson's Disease, Frontotemporal Dementia)
• Presence of standard contraindications for rTMS
• Currently pregnant
• Significant sensitivity to noise
• Medical treatments or conditions that lower seizure threshold
• History of severe brain injury
• History of seizures/epilepsy
• Currently taking chronic opiate medications or substances
• Inability or unwillingness of subject to give informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa McTeague, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Other Identifiers

Pro00126644

Identifier Type: -

Identifier Source: org_study_id