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

NCT05917002 | Withdrawn DMC

• 1 other identifier: Pro00126644
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Baratt Impulsiveness Scale

  Change in 30-item self-report scale that is commonly used to measure impulsiveness. Participants respond to each item using a 4-point Likert scale: 1 (rarely/never), 2 (occasionally), 3 (often), and 4 (almost always/always).

  Change assessed at visit 1 (day 1) and visit 2 (day 2)

Study Arms (2)

Real TBS to the mPFC

EXPERIMENTAL

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.

Device: Real TBS to mPFC

Sham TBS to the mPFC

SHAM COMPARATOR

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)

Device: Sham TBS to mPFC

Interventions

Real TBS to mPFC DEVICE

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

Real TBS to the mPFC

Sham TBS to mPFC 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.

Sham TBS to the mPFC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Officials

• Lisa McTeague, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study is double blinded. Both the investigators and the participants will be blinded as to which method of stimulation they receive first.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to receive active or sham stimulation either first or second. All participants will receive active and sham during the study, only the order will be randomized.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: June 23, 2023
• Study Start: August 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09